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2010
Report
M
E D I C I N E S
I N
D
E V E L O P M E N T
F O R
Mental Illnesses
P R E S E N T E D
B Y
A M E R I C A
’
S
P H A R M A C E U T I C A L
R E S E A R C H
C O M P A N I E S
Pharmaceutical Research Companies Are Developing
More Than 300 Medicines to Treat Mental Illnesses
A
merica’s pharmaceutical research and biotechnology companies are currently developing 313
medicines to help the nearly 60 million American
adults today suffering from some form of mental illness—
from Alzheimer’s disease to depression and from
schizophrenia to addictive disorders, such as dependence
on alcohol or drugs. All of the medicines are either in
clinical trials or awaiting review by the Food and Drug
Administration.
Over the past half century, pharmaceutical research has
helped transform mental illnesses from misunderstood
causes of shame and fear into often highly treatable conditions. For example, medicines for treating depression are
helping thousands of people suffering from this disease live
productive lives. Breakthrough schizophrenia medicines
enable most patients to be treated in the community rather
than institutional settings, and medicines for Alzheimer’s
disease are helping elderly people maintain their independence longer.
Despite such progress, mental illnesses continue to
exact a heavy human and economic toll. The National
Institute of Mental Health (NIMH) estimates that 1 in 4
American adults suffer from a diagnosable mental disorder. According to the World Health Organization, more
than 300 million people worldwide suffer from a mental
health disorder. Mental illness, including suicide, accounts
for more than 15 percent of the burden of disease in
established market economies, which is more than the
disease burden caused by all cancers. According to a
study funded by the NIMH, serious mental illnesses cost
the United States more than $317 billion annually in lost
wages, health care expenditures and disability benefits.
New medicines today in the research and development
pipeline offer hope of reducing the human and economic
costs of mental illnesses. They include: 71 for depression
(mood disorders), which affects nearly 21 million Americans;
33 for addictive disorders, including dependence on
alcohol, tobacco or illicit drugs; 38 medicines for anxiety
disorders, which affect more than 40 million adults ages
18 and older; 90 for dementias, including Alzheimer’s
disease, which affects more than 5 million Americans;
and 54 for schizophrenia, which strikes some 2.4 million
American adults each year. Other potential medicines
target attention-deficit/hyperactivity disorder, autism,
eating disorders, personality disorders, premenstrual
disorders and sleep disorders.
MEDICINES
ILLNESSES*
IN
DEVELOPMENT
Addictive Disorders
FOR
MENTAL
33
Anxiety Disorders
38
Attention-Deficit/
Hyperactivity Disorder
20
90
Dementias
Depression
Developmental
Disorders
71
6
33
Eating Disorders
Personality Disorders
2
Premenstrual Disorders
2
Schizophrenia
54
21
Sleep Disorders
Other
3
* Some medicines are in development for more than one disorder.
Examples of some medicines now being tested to treat
mental illnesses include:
• A medicine to potentially treat the varied symptoms
associated with schizophrenia, with diminished side
effects common with current treatments.
• A medicine designed to remove beta amyloid protein
from the brain and prevent or reverse progression of
Alzheimer’s disease.
Researching and developing new medicines remains a
risky investment and lengthy process—costing, on average,
$1.3 billion and taking between 10 and 15 years to
bring a new medicine to patients. But advances in our
understanding of mental illnesses and how to treat them
have allowed America’s pharmaceutical research and
biotechnology companies to conduct the cutting-edge
research needed to reduce the destructive toll of these
disorders and to allow more patients to lead healthier,
happier, more productive lives.
David E. Wheadon, M.D.
Senior Vice President,
Scientific & Regulatory Affairs
PhRMA
Medicines in Development for
Mental Illnesses
ADDICTIVE DISORDERS
Product Name
Sponsor
Indication
Development Status*
468816
GlaxoSmithKline
Rsch. Triangle Park, NC
nicotine dependence
Phase II
(888) 825-5249
618334
GlaxoSmithKline
Rsch. Triangle Park, NC
drug dependence
Phase I
(888) 825-5249
AFQ056
Novartis Pharmaceuticals
East Hanover, NJ
smoking withdrawal
(see also developmental disorders)
Phase I completed
(888) 669-6682
alcohol
dependence
therapy
Eli Lilly
Indianapolis, IN
alcohol dependence
Phase I
(800) 545-5979
alcohol
dependence
therapy
Eli Lilly
Indianapolis, IN
alcohol dependence
Phase I
(800) 545-5979
ALKS 29
(baclofen/ALKS 33
combination)
Alkermes
Cambridge, MA
alcohol dependence
Phase I/II
(617) 494-0171
ALKS 33
Alkermes
Cambridge, MA
Phase II
(617) 494-0171
-------------------------------------------------------------------------------------Phase I
drug dependence,
(617) 494-0171
impulse control disorder
ARD-1600
(nicotine
inhalation)
Aradigm
Hayward, CA
nicotine dependence
Phase I
(510) 265-9000
CPP-109
(vigabatrin)
Catalyst Pharmaceutical
Coral Gables, FL
cocaine dependence
(Fast Track)
Phase II
(305) 529-2522
DOV-102677
DOV Pharmaceutical
Little Falls, NJ
alcohol dependence
Phase I
(732) 907-3600
EMB-001
Embera NeuroTherapeutics cocaine dependence
Shreveport, LA
KRL-901
Krele Pharmaceuticals
Saddle River, NJ
alcohol dependence
in clinical trials
(212) 923-3400
lobeline
Yaupon Therapeutics
Radnor, PA
methamphetamine dependence
(see also ADHD)
Phase II
(610) 975-9290
lofexidine
US WorldMeds
Louisville, KY
opioid dependence
Phase III
(502) 753-2094
MK-0594
Merck
Whitehouse Station, NJ
alcohol dependence
Phase II
(800) 672-6372
MS-166
MediciNova
San Diego, CA
opioid dependence
Phase II
(858) 373-1500
alcohol dependence
Phase I completed
(318) 213-0198
* For more information about a specific medicine in this report, please call the telephone number listed.
2
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Mental Illnesses 2010
ADDICTIVE DISORDERS
Product Name
Sponsor
Indication
nalmefene
Lundbeck
Deerfield, IL
alcohol dependence
Phase III
(800) 455-1141
-------------------------------------------------------------------------------------nicotine dependence
Phase II
(800) 455-1141
Namenda®
memantine
Forest Laboratories
New York, NY
impulse control disorder
(compulsive gambling)
Phase II
(800) 947-5227
NanoBUP™
buprenorphine/
naloxone
Nanotherapeutics
Alachua, FL
opioid dependence
Phase I completed
(386) 462-9663
neboglamine
(CR 2249)
Rottapharm | Madaus
Monza, Italy
cocaine dependence
Phase II
www.rotta.com
NIC 002
Novartis Pharmaceuticals
East Hanover, NJ
nicotine dependence
Phase II
(888) 669-6682
NicVAX™
nicotine abuse
vaccine
GlaxoSmithKline
Rsch. Triangle Park, NC
Nabi Biopharmaceuticals
Boca Raton, FL
nicotine dependence
(Fast Track)
Phase III
(888) 825-5249
OpRA
Eli Lilly
Indianapolis, IN
alcohol dependence
Phase II
(800) 545-5979
Probuphine®
bupenorphine
Titan Pharmaceuticals
South San Francisco, CA
opioid dependence
Phase III
(650) 244-4990
Risperdal® Consta® Johnson & Johnson
risperidone
Pharmaceutical Research
(injectable)
& Development
Raritan, NJ
methamphetamine dependence
(see also schizophrenia)
Phase II
(800) 817-5286
SCH 900435
Merck
Whitehouse Station, NJ
alcohol dependence
(prevention of relapse)
(see also schizophrenia)
Phase II
(800) 672-6372
Seroquel XR®
quetiapine
fumarate
extended-release
AstraZeneca
Wilmington, DE
alcohol dependence
(see also anxiety disorders,
depression, personality disorders)
Phase II completed
(800) 236-9933
SYN-117
Roche
Nutley, NJ
Synosia Therapeutics
South San Francisco, CA
drug dependence
(see also anxiety disorders)
Phase I/II
(973) 235-5000
(650) 244-4850
TA-CD
(cocaine abuse
vaccine)
Celtic Pharma
Hamilton, Bermuda
cocaine dependence
Phase II
www.celticpharma.com
TO-2060
(olanzepine/
ondansetron)
Transcept Pharmaceuticals
Pt. Richmond, CA
alcohol dependence
Phase I
(510) 215-3500
Topamax®
topiramate
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
alcohol dependence
(see also anxiety disorders)
Phase II
(800) 817-5286
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Mental Illnesses 2010
Development Status
3
ADDICTIVE DISORDERS
Product Name
Sponsor
Indication
vigabatrin
Lundbeck
Deerfield, IL
cocaine dependence
Phase II
(Fast Track)
(847) 282-1000
-------------------------------------------------------------------------------------methamphetamine dependence
Phase I
(847) 282-1000
Vivitrol®
naltrexone
controlled-release
Alkermes
Cambridge, MA
opioid dependence
application submitted
(617) 494-0171
ANXIETY DISORDERS
4
Development Status
Product Name
Sponsor
Indication
Development Status
163090
GlaxoSmithKline
Rsch. Triangle Park, NC
anxiety
(see also depression)
Phase I
(888) 825-5249
356278
GlaxoSmithKline
Rsch. Triangle Park, NC
anxiety
(see also depression)
Phase I
(888) 825-5249
424887
GlaxoSmithKline
Rsch. Triangle Park, NC
anxiety
(see also depression)
Phase I
(888) 825-5249
586529
GlaxoSmithKline
Rsch. Triangle Park, NC
Neurocrine Biosciences
San Diego, CA
anxiety
(see also depression)
Phase I
(888) 825-5249
(858) 617-7600
588045
GlaxoSmithKline
Rsch. Triangle Park, NC
anxiety
(see also depression)
Phase I
(888) 825-5249
ABT-436
Abbott Laboratories
Abbott Park, IL
anxiety
(see also depression)
Phase I
(847) 937-6100
ADX71149
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
anxiety
(see also schizophrenia)
Phase I
(800) 817-5286
AVN101
Avineuro Pharmaceuticals
San Diego, CA
anxiety
(see also dementias)
Phase II
(858) 436-1537
AVN397
Avineuro Pharmaceuticals
San Diego, CA
anxiety
(see also dementias)
Phase II
(858) 436-1537
AZD2327
AstraZeneca
Wilmington, DE
anxiety
(see also depression)
Phase II
(800) 236-9933
AZD6280
AstraZeneca
Wilmington, DE
anxiety
Phase I
(800) 236-9933
BCI-540
BrainCells
San Diego, CA
anxiety
(see also depression)
Phase II
(858) 812-7700
emicerfont
GlaxoSmithKline
Rsch. Triangle Park, NC
Neurocrine Biosciences
San Diego, CA
anxiety
(see also depression)
Phase II
(888) 825-5249
(858) 617-7600
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Mental Illnesses 2010
ANXIETY DISORDERS
Product Name
Sponsor
Indication
Development Status
KRL-104
Krele Pharmaceuticals
Saddle River, NJ
generalized anxiety disorder
in clinical trials
(212) 923-3400
Lexapro®
escitalopram
Forest Laboratories
New York, NY
panic disorder, social phobia
application submitted
(800) 947-5227
Lu AA21004
Lundbeck
Deerfield, IL
generalized anxiety disorder
(see also depression)
Phase III
(800) 455-1141
Lu AA24530
Lundbeck
Deerfield, IL
generalized anxiety disorder
(see also depression)
Phase I
(800) 455-1141
Lunesta®
eszopiclone
Sepracor
Marlborough, MA
generalized anxiety disorder
(see also sleep disorders)
Phase II
(508) 481-6700
Lyrica®
pregbalin
Pfizer
New York, NY
generalized anxiety disorder
application submitted
(860) 732-5156
MDMA
Multidisciplinary
Association for
Psychedelic Studies
Santa Cruz, CA
post-traumatic stress disorder
Phase I
(831) 421-6362
NSD-721
GlaxoSmithKline
Rsch. Triangle Park, NC
NeuroSearch
Ballerup, Denmark
social anxiety disorder
Phase I
(888) 825-5249
NSD-788
GlaxoSmithKline
Rsch. Triangle Park, NC
NeuroSearch
Ballerup, Denmark
anxiety
(see also depression)
Phase I
(888) 825-5249
orvepitant
GlaxoSmithKline
Rsch. Triangle Park, NC
post-traumatic stress disorder
(see also depression)
Phase II
(888) 825-5249
PH94B
Pherin Pharmaceuticals
Redwood City, CA
acute anxiety disorder
Phase II
(650) 568-1587
Seroquel XR®
quetiapine
fumarate
extended-release
AstraZeneca
Wilmington, DE
generalized anxiety disorders
(see also addictive disorders,
depression, personality disorders)
application submitted
(800) 236-9933
SPN 805
Supernus Pharmaceuticals
Rockville, MD
anxiety
Phase I
(301) 838-2500
SPN 808
Supernus Pharmaceuticals
Rockville, MD
anxiety
Phase I
(301) 838-2500
SRX 246
Azevan Pharmaceuticals
Bethlehem, PA
traumatic stress disorders
Phase I
(610) 419-1057
SSR125543
sanofi-aventis
Bridgewater, NJ
post-traumatic stress disorder
(see also depression)
Phase I
(800) 633-1610
Strattera®
atomoxetine
Eli Lilly
Indianapolis, IN
social phobia
Phase II/III
(800) 545-5979
SYN-117
Roche
Nutley, NJ
Synosia Therapeutics
South San Francisco, CA
post-traumatic stress disorder
(see also addictive disorders)
Phase II
(973) 235-5000
(650) 244-4850
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ANXIETY DISORDERS
Product Name
Sponsor
Indication
Development Status
TGWOOAA
Fabre-Kramer
Pharmaceuticals
Houston, TX
generalized anxiety disorder,
social phobia
Phase II
(713) 975-6900
TIK-101
(cycloserine)
Tikvah Therapeutics
Atlanta, GA
obsessive-compulsive disorder,
panic disorder, phobic disorders,
post-traumatic stress disorder,
social phobia
Phase II
(404) 920-3180
Topamax®
topiramate
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
post-traumatic stress disorder
(see also addictive disorders)
in clinical trials
(800) 817-5286
TriRima™
(CX157)
CeNeRx BioPharma
Rsch. Triangle Park, NC
anxiety
(see also depression)
Phase I
(919) 234-4650
verucerfont
GlaxoSmithKline
Rsch. Triangle Park, NC
Neurocrine Biosciences
San Diego, CA
post-traumatic stress disorder,
social phobia
(see also depression)
Phase II
(888) 825-5249
(858) 617-7600
YKP-3089
SK Drug Development
Center
Fairfield, NJ
anxiety
Phase II
(973) 227-3939
Zoloft®
sertraline
Pfizer
New York, NY
generalized anxiety disorder
(see also eating disorders)
in clinical trials
(860) 732-5156
ATTENTION-DEFICIT/HYPERACTIVITY DISORDER
6
Product Name
Sponsor
Indication
Development Status
amfetamine
transdermal
Noven Pharmaceuticals
Miami, FL
attention-deficit/hyperactivity
disorder (ADHD)
Phase I
(305) 253-5099
AZD1446
(TC-6683)
AstraZeneca
Wilmington, DE
Targacept
Winston-Salem, NC
ADHD
(see also dementias)
Phase II
(800) 236-9933
(336) 480-2100
AZD3480
(TC-1734)
AstraZeneca
Wilmington, DE
Targacept
Winston-Salem, NC
ADHD
Phase II
(800) 236-9933
(336) 480-2100
Clonicel®
Shionogi Pharma
clonidine
Atlanta, GA
(controlled release)
ADHD in adolescents and
children
application submitted
(800) 461-3696
Daytrana®
Shire
methylphenidate
Wayne, PA
transdermal system
ADHD in adolescents
application submitted
(800) 828-2088
-------------------------------------------------------------------------------------ADHD in adults
Phase III
(800) 828-2088
droxidopa
ADHD
(combination therapy)
Chelsea Therapeutics
Charlotte, NC
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Phase II
(704) 341-1516
F O R
Mental Illnesses 2010
ATTENTION-DEFICIT/HYPERACTIVITY DISORDER
Product Name
Sponsor
Indication
Development Status
Intuniv™
guanfacine
(extended release)
Shire
Wayne, PA
ADHD in adolescents and children
(adjunctive treatment, combination
therapy)
application submitted
(484) 595-8800
JNJ-31001074
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
ADHD
Phase II
(800) 817-5286
-------------------------------------------------------------------------------------ADHD in children and adolescents
Phase I
(800) 817-5286
KP106
KemPharm
North Liberty, IA
ADHD
Phase I
(319) 665-2575
KRL-401
Krele Pharmaceuticals
Saddle River, NJ
ADHD
in clinical trials
(212) 923-3400
lobeline
Yaupon Therapeutics
Radnor, PA
ADHD in adults
(see also addictive disorders)
Phase II
(610) 975-9209
NERI
(LY2216684)
Eli Lilly
Indianapolis, IN
ADHD
(pediatric patients)
(see also depression)
Phase II/III
(800) 545-5979
OPC-34712
Otsuka America
Pharmaceutical
Rockville, MD
ADHD
(adjunctive treatment)
(see also depression, schizophrenia)
Phase II
(800) 562-3974
SEP-228432
Sepracor
Marlborough, MA
ADHD
Phase I/II
(508) 481-6700
sofinicline
Abbott Laboratories
Abbott Park, IL
ADHD
Phase II
(847) 937-6100
SPN 810
Supernus Pharmaceuticals
Rockville, MD
ADHD in children
Phase II completed
(301) 838-2500
SPN 811
Supernus Pharmaceuticals
Rockville, MD
ADHD
Phase I
(301) 838-2500
SPN 812V
Supernus Pharmaceuticals
Rockville, MD
ADHD
Phase I/II
(301) 838-2500
TC5619
AstraZeneca
Wilmington, DE
Targacept
Winston-Salem, NC
ADHD
(see also dementias)
Phase II
(800) 236-9933
Vyvanse®
lisdexamfetamine
dimesylate
Shire
Wayne, PA
ADHD in adolescents
(see also depression, schizophrenia,
sleep disorders)
Phase III
(800) 828-2088
Indication
Development Status
DEMENTIAS
Product Name
Sponsor
Diseases in this category are medical conditions involving the brain and can also be categorized as neurological disorders.
18-flutemetamol
GE Healthcare
(PET imaging agent) Waukesha, WI
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Alzheimer’s disease diagnosis
F O R
Mental Illnesses 2010
Phase III
www.gehealthcare.com
7
DEMENTIAS
8
Product Name
Sponsor
Indication
239512
GlaxoSmithKline
Rsch. Triangle Park, NC
Alzheimer’s disease
Phase II
(see also schizophrenia)
(888) 825-5249
-------------------------------------------------------------------------------------mild cognitive impairment
Phase I completed
(888) 825-5249
742457
GlaxoSmithKline
Rsch. Triangle Park, NC
Alzheimer’s disease
Phase II
(888) 825-5249
933776A
GlaxoSmithKline
Rsch. Triangle Park, NC
Alzheimer’s disease
Phase I
(888) 825-5249
1034702
GlaxoSmithKline
Rsch. Triangle Park, NC
dementia
(see also schizophrenia)
Phase I
(888) 825-5249
AAB-002
Janssen Alzheimer
Immunotherapy
South San Francisco, CA
Pfizer
New York, NY
Alzheimer’s disease
Phase 0
(800) 817-5286
(860) 732-5156
AAB-003
Janssen Alzheimer
Immunotherapy
South San Francisco, CA
Pfizer
New York, NY
Alzheimer’s disease
Phase 0
(800) 817-5286
(860) 732-5156
ABT-126
Abbott Laboratories
Abbott Park, IL
Alzheimer’s disease
Phase II
(see also schizophrenia)
(847) 937-6100
-------------------------------------------------------------------------------------Alzheimer’s disease in the elderly
Phase I
(847) 937-6100
ABT-288
Abbott Laboratories
Abbott Park, IL
Alzheimer’s disease
(see also schizophrenia)
Phase II
(847) 937-6100
ABT-384
Abbott Laboratories
Abbott Park, IL
Alzheimer’s disease
Phase II
(847) 937-6100
ABT-560
Abbott Laboratories
Abbott Park, IL
cognition disorders
Phase I
(847) 937-6100
ACC-002
Janssen Alzheimer
Immunotherapy
South San Francisco, CA
Pfizer
New York, NY
Alzheimer’s disease
Phase 0
(800) 817-5286
(860) 732-5156
AD02
vaccine
Affiris
Vienna, Austria
GlaxoSmithKline
Rsch. Triangle Park, NC
Alzheimer’s disease
Phase II
(888) 825-5249
ADS-8703
Adamas Pharmaceuticals
Emeryville, CA
dementia
Phase II
(510) 450-3500
Alzheimer’s
therapy
Eli Lilly
Indianapolis, IN
agitation in Alzheimer’s disease
Phase II
(800) 545-5979
AMG 747
Amgen
Thousand Oaks, CA
cognition disorders associated
with schizophrenia
Phase I
(805) 447-1000
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DEMENTIAS
Product Name
Sponsor
Indication
Development Status
ARC029
Archer Pharmaceuticals
Sarasota, FL
Alzheimer’s disease
Phase I
(941) 755-6644
ARC031
Archer Pharmaceuticals
Sarasota, FL
Alzheimer’s disease
Phase I
(941) 755-6644
ASP 0777
Astellas Pharma US
Deerfield, IL
Alzheimer’s disease
Phase I
(800) 695-4321
AV965
Avera Pharmaceuticals
San Diego, CA
Alzheimer’s disease,
cognition disorders
Phase I
(858) 847-0650
AVN 101
Avineuro Pharmaceuticals
San Diego, CA
Alzheimer’s disease
(see also anxiety disorders)
Phase II
(858) 436-1537
AVN 322
Avineuro Pharmaceuticals
San Diego, CA
Alzheimer’s disease
Phase I
(858) 436-1537
AVN 397
Avineuro Pharmaceuticals
San Diego, CA
Alzheimer’s disease
(see also anxiety disorders)
Phase II
(858) 436-1537
Axona™
Accera
Broomfield, CO
age-associated memory
impairment
Phase II
(303) 439-0004
AZD1446
(TC-6683)
AstraZeneca
Wilmington, DE
Targacept
Winston-Salem, NC
Alzheimer’s disease
(see also ADHD)
Phase II
(800) 236-9933
(336) 480-2100
bapineuzumab
(AAB-001)
Janssen Alzheimer
Immunotherapy
South San Francisco, CA
Pfizer
New York, NY
Alzheimer’s disease
Phase III
(intravenous)
(800) 817-5286
(Fast Track)
(860) 732-5156
-------------------------------------------------------------------------------------Alzheimer’s disease
Phase II
(subcutaneous)
(800) 817-5286
(860) 732-5156
BAY 85-8101
Bayer HealthCare
(PET imaging agent) Pharmaceuticals
Wayne, NJ
Alzheimer’s disease diagnosis
Phase I
(888) 842-2937
BAY 94-9172
Avid Radiopharmaceuticals Alzheimer’s disease diagnosis
(florbetaben)
Philadelphia, PA
(PET imaging agent) Bayer HealthCare
Pharmaceuticals
Wayne, NJ
Phase III
(215) 298-0700
(888) 842-2937
begacestat
Pfizer
New York, NY
Alzheimer’s disease
Phase I
(860) 732-5156
bisnorcymserine
(BNC)
QR Pharma
Radnor, PA
advanced Alzheimer’s disease
Phase I
(484) 253-2296
C105
Cognition Pharmaceuticals
New York, NY
cognitive impairment/deficit
associated with multiple sclerosis
Phase II
(212) 906-7071
CAD106
CytosBiotechnology
Postfach, Switzerland
Novartis Pharmaceuticals
East Hanover, NJ
Alzheimer’s disease
Phase II
(888) 669-6682
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DEMENTIAS
10
Product Name
Sponsor
Indication
Development Status
CEP-26401
Cephalon
Frazer, PA
cognition disorders
Phase I
(610) 344-0200
CERE-110
(gene therapy)
Ceregene
San Diego, CA
Alzheimer’s disease
Phase II
(858) 458-8800
CHF 5074
Chiesi Pharmaceuticals
Rockville, MD
Alzheimer’s disease
Phase I
(301) 424-2661
CTS-21166
Astellas Pharma US
Deerfield, IL
CoMentis
South San Francisco, CA
Alzheimer’s disease
Phase I
(800) 695-4321
(650) 359-2600
davunetide
intranasal
Allon Therapeutics
Vancouver, Canada
Alzheimer’s disease,
cognitive impairment
associated with schizophrenia
Phase II
(604) 736-0634
davunetide
intravenous
Allon Therapeutics
Vancouver, Canada
mild cognitive impairment
Phase II
(604) 736-0634
DEBIO 9902
Debiopharm
Lausanne, Switzerland
Alzheimer’s disease
Phase I
www.debiopharm.com
docosahexaenoic
acid
Martek Biosciences
Columbia, MD
Alzheimer’s disease
Phase III
(410) 740-0081
E2212
Eisai
Woodcliff Lake, NJ
Alzheimer’s disease
Phase I
(888) 274-2378
EGb 761
Ipsen
Milford, MA
Alzheimer’s disease
Phase III
(508) 478-8900
ELND005
Elan Pharmaceuticals
South San Francisco, CA
Transition Therapeutics
Toronto, Canada
Alzheimer’s disease
(Fast Track)
Phase II
(650) 877-0900
(416) 260-7770
ELND006
Elan Pharmaceuticals
South San Francisco, CA
Alzheimer’s disease
Phase I
(650) 877-0900
EVP-0334
EnVivo Pharmaceuticals
Watertown, MA
Alzheimer’s disease
Phase I
(617) 225-4250
EVP-6124
EnVivo Pharmaceuticals
Watertown, MA
Alzheimer’s disease
(see also schizophrenia)
Phase II
(617) 225-4250
Exebryl-1®
ProteoTech
Kirkland, WA
Alzheimer’s disease
Phase I
(425) 823-0400
florbetapir F 18
Avid Radiopharmaceuticals Alzheimer’s disease diagnosis
(PET imaging agent) Philadelphia, PA
Phase III
(215) 298-0700
Gammagard S/D™ Baxter Healthcare
immune globulin
Deerfield, IL
(IVIG)
Alzheimer’s disease
(early-stage, mid-stage disease)
Phase III
(800) 422-9837
gamma secretase
inhibitor
Bristol-Myers Squibb
Princeton, NJ
Alzheimer’s disease
(mild to moderate),
pre-dementia Alzheimer’s disease
Phase II
(212) 546-4000
HPP-854
TransTech Pharma
High Point, NC
Alzheimer’s disease
Phase I
(336) 841-0300
M
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I N
D
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F O R
Mental Illnesses 2010
DEMENTIAS
Product Name
Sponsor
Indication
Development Status
HT-0712
Helicon Therapeutics
Farmingdale, NY
cognition disorders
Phase I
(631) 370-8818
HTC-867
Pfizer
New York, NY
cognitive impairment associated
with schizophrenia
Phase I
(860) 732-5156
huperzine A
Neuro-Hitech
New York, NY
Alzheimer’s disease
Phase II
(212) 594-1225
intravenous
normal human
immunoglobulin
Grifols USA
Los Angeles, CA
Alzheimer’s disease
in clinical trials
(888) 474-3657
latrepirdine
Medivation
San Francisco, CA
Pfizer
New York, NY
early-stage Alzheimer’s disease
Phase III
(415) 543-3470
(860) 732-5156
-------------------------------------------------------------------------------------Alzheimer’s disease
Phase I
(combination therapy)
(415) 543-3470
(860) 732-5156
Lipitor®
atorvastatin
Pfizer
New York, NY
Alzheimer’s disease
(combination therapy)
Phase III
(860) 732-5156
Lu AE58054
Lundbeck
Deerfield, IL
cognitive impairment associated
with schizophrenia
Phase II
(800) 455-1141
LY2886721
Eli Lilly
Indianapolis, IN
Alzheimer’s disease
Phase I
(800) 545-5979
MCD-386CR
Mithridion
Madison, WI
Alzheimer’s disease
Phase I
(608) 443-2432
NIC5-15
Humanetics
Eden Prairie, MN
Alzheimer’s disease
Phase II completed
(952) 937-7660
NSA-789
Pfizer
New York, NY
Alzheimer’s disease
(see also schizophrenia)
Phase I
(860) 732-5156
Oxigon™
indolepropionic
acid derivative
Intellect Neurosciences
New York, NY
Alzheimer’s disease
Phase I
(212) 448-9300
PF-3654746
Pfizer
New York, NY
Alzheimer’s disease
(adjunctive treatment)
Phase I
(860) 732-5156
PF-3654764
Pfizer
New York, NY
Alzheimer’s disease
Phase I completed
(860) 732-5156
PF-4360365
Pfizer
New York, NY
Alzheimer’s disease
Phase II
(860) 732-5156
PF-4447943
Pfizer
New York, NY
Alzheimer’s disease
Phase II
(860) 732-5156
-------------------------------------------------------------------------------------Alzheimer’s disease
Phase I
(combination therapy)
(860) 732-5156
PF-4494700
Pfizer
New York, NY
Alzheimer’s disease
Phase II
(860) 732-5156
PF-5212365
Pfizer
New York, NY
Alzheimer’s disease
(see also schizophrenia)
Phase II
(860) 732-5156
M
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I N
D
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F O R
Mental Illnesses 2010
11
DEMENTIAS
12
Product Name
Sponsor
Indication
Development Status
PF-5212377
Pfizer
New York, NY
Alzheimer’s disease
Phase II
(860) 732-5156
PF-5236806
Janssen Alzheimer
Immunotherapy
South San Francisco, CA
Pfizer
New York, NY
Alzheimer’s disease
Phase II
(800) 934-5556
(212) 407-5740
Posiphen™
R-phenserine
QR Pharma
Radnor, PA
Alzheimer’s disease,
mild cognitive impairment
Phase II
(484) 253-2296
RG1450
(gantenerumab)
Roche
Nutley, NJ
Alzheimer’s disease
Phase I
(973) 235-5000
RG1662
Roche
Nutley, NJ
Alzheimer’s disease
Phase I
(973) 235-5000
RG3487
Roche
Nutley, NJ
Alzheimer’s disease, cognitive
impairment associated with
schizophrenia
Phase II
(973) 235-5000
RG7412
(anti-Abeta)
Genentech
South San Francisco, CA
Alzheimer’s disease
Phase I
(800) 626-3553
RVX-208
Resverlogix
Calgary, Canada
Alzheimer’s disease
Phase I
(403) 254-9252
SAR110894
sanofi-aventis
Bridgewater, NJ
Alzheimer’s disease
Phase I
(800) 633-1610
semagacestat
Eli Lilly
Indianapolis, IN
Alzheimer’s disease
Phase III
(800) 545-5979
SEP-227900
Sepracor
Marlborough, MA
Alzheimer’s disease,
cognition disorders
Phase I
(508) 481-6700
solanezumab
Eli Lilly
Indianapolis, IN
Alzheimer’s disease
Phase III
(800) 545-5979
ST-101
Sonexa Therapeutics
San Diego, CA
Alzheimer’s disease
Phase II
(858) 356-6250
SYN-114
Synosia Therapeutics
South San Francisco, CA
cognition disorders
Phase I
(650) 244-4850
SYN-120
Synosia Therapeutics
South San Francisco, CA
cognition disorders
Phase I
(650) 244-4850
T-817MA
Toyama Chemical
Tokyo, Japan
Alzheimer’s disease
Phase II
TC5619
AstraZeneca
Wilmington, DE
Targacept
Winston-Salem, NC
cognition disorders associated
with schizophrenia
(see also ADHD)
Phase II
(800) 236-9933
TD-5108
Theravance
South San Francisco, CA
Alzheimer’s disease
Phase I
(877) 275-8479
TD-8954
Theravance
South San Francisco, CA
Alzheimer’s disease
Phase I
(877) 275-8479
M
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I N
D
E V E L O P M E N T
F O R
Mental Illnesses 2010
DEMENTIAS
Product Name
Sponsor
Indication
Development Status
V950
Merck
Whitehouse Station, NJ
Alzheimer’s disease
Phase I
(800) 672-6372
varenicline
Pfizer
New York, NY
Alzheimer’s disease
(see also schizophrenia)
Phase II
(860) 732-5156
DEPRESSION
Product Name
Sponsor
Indication
Development Status
163090
GlaxoSmithKline
Rsch. Triangle Park, NC
depression
(see also anxiety disorders)
Phase I
(888) 825-5249
356278
GlaxoSmithKline
Rsch. Triangle Park, NC
depression
(see also anxiety disorders)
Phase I
(888) 825-5249
424887
GlaxoSmithKline
Rsch. Triangle Park, NC
depression
(see also anxiety disorders)
Phase I
(888) 825-5249
586529
GlaxoSmithKline
Rsch. Triangle Park, NC
Neurocrine Biosciences
San Diego, CA
depression
(see also anxiety disorders)
Phase I
(888) 825-5249
(858) 617-7600
588045
GlaxoSmithKline
Rsch. Triangle Park, NC
depression
(see also anxiety disorders)
Phase I
(888) 825-5249
1014802
GlaxoSmithKline
Rsch. Triangle Park, NC
bipolar disorder
Phase I
(888) 825-5249
ABT-436
Abbott Laboratories
Abbott Park, IL
depression
(see also anxiety disorders)
Phase I
(847) 937-6100
ADX N05
Shionogi Pharma
Atlanta, GA
depression
Phase I
(800) 461-3696
AZD2327
AstraZeneca
Wilmington, DE
depression
(see also anxiety disorders)
Phase II
(800) 236-9933
AZD6765
AstraZeneca
Wilmington, DE
depression
Phase II
(800) 236-9933
AZD7268
AstraZenenca
Wilmington, DE
depression
Phase II
(800) 236-9933
BCI-540
BrainCells
San Diego, CA
depression
(see also anxiety disorders)
Phase II
(858) 812-7700
BCI-952
BrainCells
San Diego, CA
major depressive disorder
Phase II
(858) 812-7700
bupropion
IntelGenx
(controlled-release) Quebec, Canada
depression
application submitted
(514) 331-7440
cariprazine
bipolar disorder
Phase II
(see also schizophrenia)
(800) 947-5227
-------------------------------------------------------------------------------------depression
Phase II
(adjunctive treatment)
(800) 947-5227
M
E D I C I N E S
Forest Laboratories
New York, NY
I N
D
E V E L O P M E N T
F O R
Mental Illnesses 2010
13
DEPRESSION
14
Product Name
Sponsor
Indication
Development Status
Contrave™
naltrexone/
bupropion
combination
Orexigen Therapeutics
La Jolla, CA
depression
(see also eating disorders)
Phase II
(858) 436-8600
Corlux™
mifeprostone
Corcept Therapeutics
Menlo Park, CA
psychotic major depression
(Fast Track)
Phase III
(650) 327-3270
CP-601927
Pfizer
New York, NY
depression
Phase II
(860) 732-5156
Cymbalta®
duloxetide
Eli Lilly
Indianapolis, IN
major depression in children and
adolescents
Phase III
(800) 545-5979
depression therapy Eli Lilly
Indianapolis, IN
depression
Phase I
(800) 545-5979
DOV-21947
DOV Pharmaceutical
Little Falls, NJ
depression
(see also eating disorders)
Phase II
(732) 907-3600
E2508
Eisai
Woodcliff Lake, NJ
depression
Phase I
(888) 274-2378
emicerfont
GlaxoSmithKline
Rsch. Triangle Park, NC
Neurocrine Biosciences
San Diego, CA
depression
(see also anxiety disorders)
Phase II
(888) 825-5249
(858) 617-7600
EVT-101
Evotec
Hamburg, Germany
depression
Phase II
Geodon®
ziprasidone
Pfizer
New York, NY
bipolar disorders in adolescents
and children
Phase III
(860) 732-5156
GLYX-13
Naurex
Evanston, IL
depression
Phase I
www.naurex.com
Invega®
paliperidone
extended-release
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
bipolar disorder, manic episodes
(see also developmental disorders,
schizophrenia, sleep disorders)
Phase III
(800) 817-5286
Lamictal®
lamotrigine
GlaxoSmithKline
Rsch. Triangle Park, NC
bipolar disorder (elderly)
Phase III completed
(888) 825-5249
-------------------------------------------------------------------------------------bipolar disorder (10-17 years)
Phase III
(888) 825-5249
levomilnacipran
(F2695)
Forest Laboratories
New York, NY
depression
Phase III
(800) 947-5227
losmapimod
GlaxoSmithKline
Rsch. Triangle Park, NC
major depressive disorder
Phase II
(888) 825-5249
Lovaza®
omega-3-acis
ethyl esters
GlaxoSmithKline
Rsch. Triangle Park, NC
depression
Phase II
(888) 825-5249
Lu AA21004
Lundbeck
Deerfield, IL
Takeda Pharmaceuticals
North America
Deerfield, IL
major depressive disorder
(see also anxiety disorders)
Phase III
(800) 455-1141
(224) 554-6500
M
E D I C I N E S
I N
D
E V E L O P M E N T
F O R
Mental Illnesses 2010
DEPRESSION
Product Name
Sponsor
Indication
Development Status
Lu AA24530
Lundbeck
Deerfield, IL
major depressive disorder
(see also anxiety disorders)
Phase I
(800) 455-1141
lurasidone
Sepracor
Marlborough, MA
bipolar disorder
(see also schizophrenia)
Phase III
(508) 481-6700
Motiva™
nefiracetam
Neuren Pharmaceuticals
Bethesda, MD
post-stroke depression
Phase II
(301) 941-1830
Nectiv™
traxoprodil
Pfizer
New York, NY
treatment-resistant depression
(combination therapy)
Phase II
(860) 732-5156
nemifitide
Tetragenex
Pharmaceuticals
Park Ridge, NJ
depression
Phase II completed
(201) 505-1300
NERI
(LY2216684)
Eli Lilly
Indianapolis, IN
depressive disorders
(see also ADHD)
Phase II
(800) 545-5979
NMDA receptor
antagonist
Evotec
Hamburg, Germany
Roche
Nutley, NJ
treatment-resistant depression
Phase I
(973) 235-5000
NSD-788
GlaxoSmithKline
Rsch. Triangle Park, NC
NeuroSearch
Ballerup, Denmark
depression
(see also anxiety disorders)
Phase I
(888) 825-5249
Nuvigil®
armodafinil
Cephalon
Frazer, PA
bipolar depression
(adjunctive treatment)
(see also eating disorders)
Phase III
(610) 344-0200
OPC-34712
Otsuka America
Pharmaceutical
Rockville, MD
depression
(adjunctive treatment)
(see also ADHD, schizophrenia)
Phase II
(800) 562-3974
orvepitant
GlaxoSmithKline
Rsch. Triangle Park, NC
depression
(see also anxiety disorders)
Phase II
(888) 825-5249
PF-4455242
Pfizer
New York, NY
bipolar depression
Phase I
(860) 732-5156
Pristiq®
desvenlafaxine
Pfizer
New York, NY
major depressive disorder
in children and adolescents
Phase II
(860) 732-5156
RG1578
Roche
Nutley, NJ
depression
Phase I
(973) 235-5000
RG2417
Repligen
Waltham, MA
bipolar disorder
Phase II
(800) 622-2259
RG7090
Roche
Nutley, NJ
depression
(see also developmental disorders)
Phase II
(973) 235-5000
RG7166
Roche
Nutley, NJ
depression
Phase I
(973) 235-5000
RG7351
Roche
Nutley, NJ
depression
Phase I
(973) 235-5000
M
E D I C I N E S
I N
D
E V E L O P M E N T
F O R
Mental Illnesses 2010
15
DEPRESSION
16
Product Name
Sponsor
Indication
Development Status
Risperdal®
risperidone
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
bipolar disorder with anxiety or
panic disorder (monotherapy),
depression
Phase III
(800) 817-5286
Serdaxin™
clavulanic acid
Rexahn Pharmaceuticals
Rockville, MD
depressive disorders
Phase II
(240) 268-5300
Seroquel®
quetiapine
fumarate
AstraZeneca
Wilmington, DE
depression (monotherapy,
prevention of relapse)
(see also other)
application submitted
(800) 236-9933
Seroquel XR®
quetiapine
fumarate
extended-release
AstraZeneca
Wilmington, DE
bipolar depression in adolescents
and children
(see also addictive disorders,
anxiety disorders, personality
disorders)
Phase III
(800) 236-9933
SPN 802
Supernus Pharmaceuticals
Rockville, MD
bipolar disorder
Phase I
(301) 838-2500
SSR125543
sanofi-aventis
Bridgewater, NJ
major depressive disorder
(see also anxiety disorders)
Phase I
(800) 633-1610
SSR411298
sanofi-aventis
Bridgewater, NJ
depression
Phase I
(800) 633-1610
Staccato®
loxapine
inhalation
Alexza Pharmaceuticals
Palo Alto, CA
acute agitation in patients with
bipolar I disorder
(see also schizophrenia)
application submitted
(650) 687-3900
SYN-111
Synosia Therapeutics
South San Francisco, CA
bipolar disorder
Phase II
(650) 244-4850
TC5214
AstraZeneca
Wilmington, DE
Targacept
Winston-Salem, NC
major depressive disorder
Phase II
(800) 236-9933
(336) 480-2100
TGBA01AD
Fabre-Kramer
Pharmaceuticals
Houston, TX
depression
Phase II
(713) 975-6900
triple reuptake
inhibitor
Bristol-Myers Squibb
Princeton, NJ
depression
in clinical trials
(212) 546-4000
TriRima®
(CX157)
CeNeRx BioPharma
Rsch. Triangle Park, NC
depressive disorders
(see also anxiety disorders)
Phase II
(919) 234-4650
tasimelteon
Vanda Pharmaceuticals
Rockville, MD
depression
(see also sleep disorders)
Phase I
(240) 599-4500
vabicaserin
Pfizer
New York, NY
bipolar disorder
(see also schizophrenia)
Phase II
(860) 732-5156
Valdoxan®
agomelatine
Novartis Pharmaceuticals
East Hanover, NJ
major depressive disorder,
prevention of depression relapse
Phase III
(888) 669-6682
venlafaxine
deuteriumsubstituted
(SD-254)
Auspex Pharmaceuticals
Vista, CA
depression
Phase I
(760) 599-1800
M
E D I C I N E S
I N
D
E V E L O P M E N T
F O R
Mental Illnesses 2010
DEPRESSION
Product Name
Sponsor
Indication
Development Status
verucerfont
GlaxoSmithKline
Rsch. Triangle Park, NC
Neurocrine Biosciences
San Diego, CA
depression
(see also anxiety disorders)
Phase II
(888) 825-5249
(858) 617-7600
vilazodone
PGx Health
New Haven, CT
major depression
application submitted
(877) 274-9432
Vyvanse®
lisdexamfetamine
dimesylate
Shire
Wayne, PA
bipolar disorder
(see also ADHD, schizophrenia,
sleep disorders)
Phase III
(434) 595-8800
ziprasidone
extended-release
Lipocine
Salt Lake City, UT
bipolar disorder
(see also schizophrenia)
Phase I
(810) 994-7383
DEVELOPMENTAL DISORDERS
Product Name
Sponsor
Indication
Development Status
AFQ056
Novartis Pharmaceuticals
East Hanover, NJ
fragile X syndrome
(see also addictive disorders)
Phase II completed
(888) 669-6682
CM-AT
CureMark
Rye, NY
autism
(Fast Track)
Phase III
(914) 925-3450
Invega®
paliperidone
extended-release
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
aggression in adolescents and young Phase III
adults with autism
(800) 817-5289
(see also depression, schizophrenia,
sleep disorders)
RG7090
Roche
Nutley, NJ
fragile X syndrome
(see also depression)
Phase II
(973) 235-5000
STK107
Seaside Therapeutics
Cambridge, MA
fragile X syndrome
Phase I
(617) 374-9009
STK209
(arbaclofen)
Seaside Therapeutics
Cambridge, MA
autism in children and adolescents,
fragile X syndrome
Phase II
(617) 374-9009
EATING DISORDERS
Product Name
Sponsor
Indication
Development Status
181771
GlaxoSmithKline
Rsch. Triangle Park, NC
bulimia nervosa
Phase II completed
(888) 825-5249
598809
GlaxoSmithKline
Rsch. Triangle Park, NC
compulsive over-eating
Phase I
(888) 825-5249
1521498
GlaxoSmithKline
Rsch. Triangle Park, NC
obesity
Phase I
(888) 825-5249
anamorelin
Helsinn Therapeutics
Bridgewater, NJ
anorexia
(Fast Track)
Phase II
(908) 231-1435
AZD4017
AstraZeneca
Wilmington, DE
obesity
Phase I
(800) 236-9933
M
E D I C I N E S
I N
D
E V E L O P M E N T
F O R
Mental Illnesses 2010
17
EATING DISORDERS
18
Product Name
Sponsor
Indication
Development Status
AZD8329
AstraZeneca
Wilmington, DE
obesity
Phase I
(800) 236-9933
canagliflozin
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
obesity
Phase II
(800) 817-5286
cetilistat
Norgine
Amsterdam,
The Netherlands
obesity
Phase II
www.norgine.com
Contrave™
naltrexone/
bupropion
combination
Orexigen Therapeutics
La Jolla, CA
obesity
(see also depression)
application submitted
(858) 436-8600
diazoxide choline Essentialis
(controlled-release) Carlsbad, CA
obesity
Phase I
(760) 431-2646
DOV-21947
DOV Pharmaceutical
Little Falls, NJ
obesity
(see also depression)
Phase I
(732) 907-3600
Empatic™
zonisamide/
bupropion
Orexigen Therapeutics
La Jolla, CA
obesity
Phase II
(858) 875-8600
GT389255
Peptimmune
Cambridge, MA
obesity
Phase II
(617) 715-8000
HHP-404
TransTech Pharma
High Point, NC
obesity
Phase I
(336) 841-0300
Histalean™
betahistine
Obecure
Ramat Gan, Israel
obesity
Phase II
www.obecure.com
JNJ-16269110
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
obesity
Phase II
(800) 817-5286
KD-3010
Kalypsys
San Diego, CA
obesity
Phase I
(858) 754-3300
lorcaserin
Arena Pharmaceuticals
San Diego, CA
obesity
application submitted
(858) 453-7200
NN9161
Novo Nordisk
Princeton, NJ
obesity
Phase I/II
(609) 987-5800
Nuvigil®
armodafinil
Cephalon
Frazer, PA
binge eating disorder
(see also depression)
Phase III
(610) 344-0200
OAP-189
Pfizer
New York, NY
obesity
Phase I
(860) 732-5156
obesity therapy
Eli Lilly
Indianapolis, IN
obesity
Phase II
(800) 545-5979
pramlintide/
metreleptin
combination
Amylin Pharmaceuticals
San Diego, CA
Takeda Pharmaceuticals
North America
Deerfield, IL
obesity
Phase II
(858) 552-2200
(877) 587-5332
M
E D I C I N E S
I N
D
E V E L O P M E N T
F O R
Mental Illnesses 2010
EATING DISORDERS
Product Name
Sponsor
Indication
Development Status
Qnexa™
phentermine/
topiramate
VIVUS
Mountain View, CA
obesity
application submitted
(650) 934-5200
S-2367
Shionogi USA
Florham Park, NJ
obesity
Phase II
(973) 966-6900
S-234462
Shionogi USA
Florham Park, NJ
obesity
Phase I
(973) 966-6900
sobetirome
QuatRx Pharmaceuticals
Ann Arbor, MI
obesity
Phase I
(734) 913-9900
TKS1225
Pfizer
New York, NY
obesity
Phase I
(860) 732-5156
TTP-435
TransTech Pharma
High Point, NC
obesity
Phase I
(336) 841-0300
Victoza®
liraglutide
Novo Nordisk
Princeton, NJ
obesity
(second-line therapy)
Phase III
(609) 987-5800
ZGN-433
Zafgen
Cambridge, MA
obesity
Phase I
(617) 864-1645
Zoloft®
sertraline
Pfizer
New York, NY
obesity
(see also anxiety disorders)
in clinical trials
(860) 732-5156
Zyprexa®
olanzapine
Eli Lilly
Indianapolis, IN
anorexia nervosa
(see also personality disorders)
Phase II
(800) 545-5979
PERSONALITY DISORDERS
Product Name
Sponsor
Indication
Development Status
Seroquel XR®
quetiapine
fumarate
extended-release
AstraZeneca
Wilmington, DE
borderline personality disorder
(see also addictive disorders,
anxiety disorders, depression)
Phase III
(800) 236-9933
Zyprexa®
olanzapine
Eli Lilly
Indianapolis, IN
borderline personality disorder
(see also eating disorders)
Phase III completed
(800) 545-5979
PREMENSTRUAL DISORDERS
Product Name
Sponsor
Indication
Development Status
Lybrel™
levonorgestrel/EE
Pfizer
New York, NY
premenstrual dysphoric disorder
Phase III
(860) 732-5156
PH80
Pherin Pharmaceuticals
Redwood City, CA
premenstrual dysphoric disorder,
premenstrual syndrome
Phase II completed
(650) 568-1587
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SCHIZOPHRENIA
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Product Name
Sponsor
Indication
Development Status
239512
GlaxoSmithKline
Rsch. Triangle Park, NC
schizophrenia
(see also dementias)
Phase II
(888) 825-5249
729327
GlaxoSmithKline
Rsch. Triangle Park, NC
schizophrenia
Phase I
(888) 825-5249
773812
GlaxoSmithKline
Rsch. Triangle Park, NC
schizophrenia
Phase II completed
(888) 825-5249
1018921
GlaxoSmithKline
Rsch. Triangle Park, NC
schizophrenia
Phase I
(888) 825-5249
1034702
GlaxoSmithKline
Rsch. Triangle Park, NC
schizophrenia
(see also dementias)
Phase I
(888) 825-5249
1144814
GlaxoSmithKline
Rsch. Triangle Park, NC
schizophrenia
Phase I
(888) 825-5249
Abilify® IM Depot
aripiprazole
Bristol-Myers Squibb
Princeton, NJ
Otsuka America
Pharmaceutical
Rockville, MD
schizophrenia
Phase III
(860) 732-5156
(800) 562-3974
ABT-126
Abbott Laboratories
Abbott Park, IL
schizophrenia
(see also dementias)
Phase II
(847) 937-6100
ABT-288
Abbott Laboratories
Abbott Park, IL
schizophrenia
(see also dementias)
Phase II
(847) 937-6100
ADX71149
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
schizophrenia
(see also anxiety disorders)
Phase I
(800) 817-5286
ATON005
Aton Pharma
Lawrenceville, NJ
psychotic disorders
Phase I
(609) 671-9010
AVN 211
Avineuro Pharmaceuticals
San Diego, CA
schizophrenia
Phase II
(858) 436-1537
AZD8418
AstraZeneca
Wilmington, DE
schizophrenia
Phase I
(800) 236-9933
AZD8529
AstraZeneca
Wilmington, DE
schizophrenia
Phase II
(800) 236-9933
BL-1020
BioLineRx
Jerusalem, Israel
schizophrenia
Phase II
www.biolinerx.com
cariprazine
Forest Laboratories
New York, NY
schizophrenia
(see also depression)
Phase III
(800) 947-5227
CM-2395
Cenomed BioSciences
Irvine, CA
schizophrenia
in clinical trials
(949) 838-0344
DCCCyB
Merck
Whitehouse Station, NJ
schizophrenia
Phase I
(800) 672-6372
EVP-6124
EnVivo Pharmaceuticals
Watertown, MA
schizophrenia
(see also dementias)
Phase II
(617) 225-4250
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SCHIZOPHRENIA
Product Name
Sponsor
Indication
Development Status
Fanapt™
iloperidone
(extended-release
injectable
formulation)
Vanda Pharmaceuticals
Rockville, MD
Novartis Pharmaceutical
East Hanover, NJ
schizophrenia
Phase I/II
(240) 599-4500
(888) 669-6682
idazoxan
Potomac Pharma
Bethesda, MD
schizophrenia
Phase II
Invega®
paliperidone
extended-release
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
schizophrenia in adolescents
(see also depression, developmental
disorders, sleep disorders)
Phase III
(800) 817-5286
ITI-007
Intra-Cellular Therapies
New York, NY
schizophrenia
(see also sleep disorders)
Phase I
(212) 923-3344
JNJ-17305600
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
schizophrenia
Phase I
(800) 817-5286
JNJ-37822681
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
schizophrenia
Phase II
(800) 817-5286
JNJ-39393406
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
schizophrenia
Phase I
(800) 817-5286
JNJ-40411813
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
psychotic disorders
Phase I
(800) 817-5286
Lu 31-30
Lundbeck
Deerfield, IL
psychosis
Phase II
(800) 455-1141
lurasidone
Sepracor
Marlborough, MA
schizophrenia
(see also depression)
application submitted
(508) 481-6700
mGlu2/3 pro II
(LY2140023)
Eli Lilly
Indianapolis, IN
schizophrenia
Phase II
(800) 545-5979
MK-2637
Merck
Whitehouse Station, NJ
schizophrenia
Phase I completed
(800) 672-6372
MK-8998
Merck
Whitehouse Station, NJ
schizophrenia
Phase II
(800) 672-6372
NSA-789
Pfizer
New York, NY
schizophrenia
(see also dementias)
Phase I
(860) 732-5156
OPC-34712
Otsuka America
Pharmaceutical
Rockville, MD
schizophrenia
(see also ADHD, depression)
Phase II
(800) 562-3974
PF-217830
Pfizer
New York, NY
schizophrenia
Phase II
(860) 732-5156
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SCHIZOPHRENIA
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Product Name
Sponsor
Indication
Development Status
PF-2400013
Pfizer
New York, NY
schizophrenia
Phase I
(860) 732-5156
PF-2545920
Pfizer
New York, NY
schizophrenia
Phase I
(860) 732-5156
PF-3463275
Pfizer
New York, NY
schizophrenia
Phase I
(860) 732-5156
PF-5212365
Pfizer
New York, NY
schizophrenia
(see also dementias)
Phase II
(860) 732-5156
pimavanserin
(ACP-103)
ACADIA Pharmaceuticals
San Diego, CA
Biovail
Mississauga, Canada
Parkinson’s disease-associated
Phase III
psychosis
(858) 558-2871
-------------------------------------------------------------------------------------schizophrenia
Phase II completed
(858) 558-2871
RG1678
Roche
Nutley, NJ
schizophrenia
Phase II completed
(973) 235-5000
Risperdal® Consta® Johnson & Johnson
risperidone
Pharmaceutical Research
(injectable)
& Development
Raritan, NJ
schizophrenia
(see also addictive disorders)
Phase I
(800) 817-5286
sabcomeline
Proximagen Neuroscience
London, United Kingdom
schizophrenia
Phase II
Saphris®
asenapine
Merck
Whitehouse Station, NJ
psychotic disorders in elderly
patients
Phase III completed
(800) 672-6372
SCH 900435
Merck
Whitehouse Station, NJ
schizophrenia
(see also addictive disorders)
Phase II
(800) 672-6372
schizophrenia
therapy
Eli Lilly
Indianapolis, IN
schizophrenia
Phase I
(800) 545-5979
sertindole
Lundbeck
Deerfield, IL
schizophrenia
application submitted
(800) 455-1141
Staccato®
loxapine
inhalation
Alexza Pharmaceuticals
Palo Alto, CA
acute agitation in schizophrenia
(see also depression)
application submitted
(650) 687-3900
TGOF02N
Fabre-Kramer
Pharmaceuticals
Houston, TX
schizophrenia
Phase II
(713) 975-6900
tiprolisant
Bioprojet
Paris, France
Ferrer
Barcelona, Spain
schizophrenia
Phase II
www.bioprojet.com
vabicaserin
Pfizer
New York, NY
schizophrenia
(see also depression)
Phase I
(860) 732-5156
varenicline
Pfizer
New York, NY
schizophrenia
(see also dementias)
Phase II
(860) 732-5156
Vyvanse®
lisdexamfetamine
dimesylate
Shire
Wayne, PA
schizophrenia
(see also ADHD, depression,
sleep disorders)
Phase II
(434) 595-8800
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SCHIZOPHRENIA
Product Name
Sponsor
Indication
Development Status
ziprasidone
extended-release
Lipocine
Salt Lake City, UT
schizophrenia
(see also depression)
Phase I
(810) 994-7383
SLEEP DISORDERS
Product Name
Sponsor
Indication
Development Status
649868
GlaxoSmithKline
Rsch. Triangle Park, NC
sleep disorders
Phase II
(888) 825-5249
ABT-652
Abbott Laboratories
Abbott Park, IL
excessive daytime sleepiness
Phase I
(847) 937-6100
almorexant
Actelion
Pharmaceuticals US
South San Francisco, CA
GlaxoSmithKline
Rsch. Triangle Park, NC
insomnia
Phase III
(650) 624-6900
(888) 825-5249
-------------------------------------------------------------------------------------insomnia in elderly
Phase II
(650) 624-6900
(888) 825-5249
AZ-007
(zaleplon
inhalation)
Alexza Pharmaceuticals
Mountain View, CA
insomnia
Phase I completed
(650) 944-7000
indiplon
Neurocrine Biosciences
(controlled-release) San Diego, CA
insomnia
application submitted
(858) 617-7600
indiplon
Neurocrine Biosciences
(immediate-release) San Diego, CA
insomnia
application submitted
(858) 617-7600
Intermezzo®
zolpidem
sublingual
Transcept Pharmaceuticals
Pt. Richmond, CA
insomnia
application submitted
(510) 215-3500
Invega®
paliperidone
extended-release
Johnson & Johnson
Pharmaceutical Research
& Development
Raritan, NJ
insomnia
(see also depression, developmental
disorders, schizophrenia)
Phase II completed
(800) 817-5286
ITI-007
Intra-Cellular Therapies
New York, NY
sleep maintenance insomnia
(see also schizophrenia)
Phase II
(212) 923-3344
KRL-102
Krele Pharmaceuticals
Saddle Brook, NJ
sleep disorders
in clinical trials
(212) 923-3400
Lunesta®
eszopiclone
Sepracor
Marlborough, MA
ADHD-associated insomnia in
adolescents and children
(see also anxiety disorders)
Phase III
(508) 481-6700
LY2624803
Eli Lilly
Indianapolis, IN
insomnia
Phase II
(800) 545-5979
melatonin
Neurim Pharmaceuticals
(controlled-release) Tel-Aviv, Israel
(Orphan Drug)
non-24-hour sleep-wake disorder
Phase III
www.neurim.com
MK-4305
insomnia
Phase III
(800) 672-6372
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Merck
Whitehouse Station, NJ
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SLEEP DISORDERS
Product Name
Sponsor
Indication
Development Status
MK-6096
Merck
Whitehouse Station, NJ
insomnia
Phase II
(800) 672-6372
MN-305
MediciNova
San Diego, CA
insomnia
Phase II
(858) 373-1500
Skye Pharma US
SKP-1041
(zaleplon
Cambridge, MA
controlled-release) Somnus Therapeutics
Bedminster, NJ
sleep disorders
Phase II
(908) 901-0300
tasimelteon
(Orphan Drug)
Vanda Pharmaceuticals
Rockville, MD
insomnia
Phase III
(see also depression)
(240) 599-4500
-------------------------------------------------------------------------------------circadian rhythm sleep disorder
Phase II
(240) 599-4500
TGAR01H
(triazolam
intranasal)
Fabre-Kramer
Pharmaceuticals
Houston, TX
insomnia
Phase II
(713) 975-6900
Vyvanse®
lisdexamfetamine
dimesylate
Shire
Wayne, PA
sleep disorders
(ADHD, depression, schizophrenia)
Phase I
(434) 595-8800
zaleplon-GR
Intec Pharma
Jerusalem, Israel
insomnia
Phase I
www.intecpharma.com
Product Name
Sponsor
Indication
Development Status
CORT 108297
Corcept Therapeutics
Menlo Park, CA
psychiatric disorders
Phase I
(650) 327-3270
MK-8368
Merck
Whitehouse Station, NJ
psychiatric disorders
Phase I
(800) 672-6372
Seroquel®
quetiapine
fumarate
AstraZeneca
Wilmington, DE
delirium
(see also depression)
Phase III
(800) 236-9933
OTHER
The content of this report has been obtained through industry sources and the Adis “R&D Insight” database
based on the latest information. Report current as of July 5, 2010. The information may not be comprehensive.
For more specific information about a particular product, contact the individual company directly or go to
www.clinicaltrials.gov. The entire series of Medicines in Development is available on PhRMA’s web site.
A publication of PhRMA’s Communications & Public Affairs Department. (202) 835-3460
www.phrma.org | www.innovation.org | www.pparx.org | www.buysafedrugs.info | www.sharingmiracles.com
Provided as a Public Service by PhRMA. Founded in 1958 as the Pharmaceutical Manufacturers Association.
Copyright © 2010 by the Pharmaceutical Research and Manufacturers of America. Permission to reprint is awarded if
proper credit is given.
24
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GLOSSARY
Alzheimer’s disease—Progressive
and chronic deterioration of all
mental functions. Early manifestations include a decrease in attention
span, impaired powers of concentration, some personality change
and forgetfulness. As the disease
progresses, there is a loss of computational ability, in addition to
word-finding problems and difficulty
with ordinary activities. Ultimately,
there is severe memory loss, complete
disorientation, social withdrawal
loss of independence, and is fatal.
It is the seventh leading cause of
death in the United States.
anxiety disorders—A group of
mental illnesses in which symptoms of anxiety (from mild unease
to intense fear) are the main feature
and there is overlap among specific
syndromes. Generalized anxiety
disorder is diagnosed if a patient
experiences unrealistic or excessive
anxiety and worry (apprehensive
expectation) about two or more
life circumstances, e.g., worry
about something bad happening
to a loved one (who is not in
danger) and worry about money
(for no reason) for six months or
longer. A diagnosis of panic disorder requires that panic attacks
—sudden feelings of apprehension
or fear accompanied by physical
symptoms such as shortness of
breath—occur with 4 out of 12
concomitant psychophysiological
symptoms, that the attacks are
severe enough and happen often
enough to be disruptive or distressing to the individual, and
that at least one attack was spontaneous, i.e., occurred in the
absence of a phobic stimulus.
application submitted—An application for marketing has been
submitted to the U.S. Food and
Drug Administration (FDA). The
application can either be an NDA
(new drug application) or a BLA
(biologic license application).
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attention deficit/hyperactivity
disorder—ADHD is a complex
neurological impairment that
results in an overactive behavior
pattern and a difficulty concentrating. While it primarily affects
children, a growing number of
adults are being diagnosed with
the disorder. Boys are afflicted
some three times as often as girls.
Children with ADHD are full of
energy, fidgety, impulsive, reckless, irritable, emotionally
immature and aggressive. Because
their attention span is short, they
do not conform to orderly routine.
ADHD often leads to anti-social
acts and difficulty learning,
although IQ is normal. No definite
cause has been established, but
some researchers now believe
heredity plays a role.
autism—A complex developmental
disorder that causes severe and
pervasive impairment in thinking,
feeling, language, and the ability to
relate to others. It is usually first
diagnosed in early childhood and
ranges from a severe form, called
autism disorder, through pervasive
development disorder, to a much
milder form, Asperger syndrome.
dementia—Degeneration of
central nervous system functions,
such as memory and learning
capacity. The natural decline of
these functions with age is grossly
exaggerated in dementia.
depression—A feeling of intense
sadness, which may follow a
recent loss or other sad event but
is out of proportion to that event
and persists beyond an appropriate
length of time. Major depressive
disorder (or major depression
syndrome) includes an episode of
depression defined as a persistent
(for at least 2 weeks) mood disturbance, plus at least 4 of the
following: sleep disturbance,
changes in psychomotor activity,
F O R
Mental Illnesses 2010
loss of ability to experience pleasure and interest, fatigue, feelings
of worthlessness or guilt, difficulty
in concentrating, and preoccupation with death or a wish to die.
Major depression is associated with
impairment in social functioning.
If criteria for major depression
have been met but in addition an
episode of mania has ever occurred,
then the diagnosis becomes bipolar
disorder (or manic-depressive
illness). The essential feature of
mania is a distinct period when
the predominant mood is either
elevated, expansive, or irritable,
with associated symptoms including
hyperactivity, pressure of speech,
flight of ideas, inflated self-esteem,
decreased need for sleep, distractibility and excessive
involvement in activities that often
are flamboyant, bizarre or disorganized.
Fast Track—Fast Track is a process
designed to facilitate the development and expedite the review of
drugs to treat serious diseases and
fill an unmet medical need. The
status is assigned by the U.S. Food
and Drug Administration. The
purpose is to get important new
drugs to the patient earlier. Fast
Track addresses a broad range of
serious diseases. Generally, determining factors include whether the
drug will have an impact on such
factors as survival, day-to-day functioning, or the likelihood that the
disease, if left untreated, will
progress from a less severe condition to a more serious one. Filling
an unmet medical need is defined
as providing a therapy where none
exists or providing a therapy which
may be potentially superior to
existing therapy. Once a drug
receives Fast Track designation,
early and frequent communication
between the FDA and a drug
company is encouraged throughout
the entire drug development and
25
GLOSSARY
review process. The frequency of
communication assures that questions and issues are resolved
quickly, often leading to earlier
drug approval and access by
patients.
fragile X syndrome (FXS)—The
most common cause of inherited
mental impairment. This impairment can range from learning
disabilities to more severe cognitive
or intellectual disabilities. FXS is
the most common known cause of
autism or “autistic-like” behaviors,
but 80-85 percent of autism cases
are of unknown cause. Symptoms
also can include characteristic
physical and behavioral features
and delays in speech and language
development.
obesity—For adults, overweight
and obesity ranges are determined
by using weight and height to calculate the “body mass index”
(BMI). BMI is used because, for
most people, it correlates with their
amount of body fat. Adults with a
BMI between 25 and 29.9 are considered overweight. An adult BMI
of 30 or higher is considered
obese.
obsessive-compulsive disorder—
A neurosis characterized primarily
by recurrent and persistent thoughts
that are intense, disgusting, frightening, absurd or otherwise alien,
accompanied by ritualized, repeti-
26
tive behavior that is usually irrational and bizarre.
Orphan Drug—A drug to treat a
disease that has a patient population of 200,000 or less, or a disease
that has a patient population of
more than 200,000 and a development cost that will not be recovered
from sales in the United States.
Orphan Drug status is assigned by
the U.S. Food and Drug
Administration.
Phase 0—First-in-human trials
conducted in accordance with
FDA’s 2006 guidance on
exploratory Investigational New
Drug (IND) studies designed to
speed up development of promising drugs by establishing very
early on whether the agent
behaves in human subjects as
was anticipated from preclinical
studies.
Phase I—Safety testing and
pharmacological profiling of new
drugs in small numbers of humans.
Phase II—Effectiveness testing and
identification of side effect profile
of new drugs in humans.
Phase III—Extensive clinical trials
in humans to verify effectiveness
and monitor adverse reactions of
new drugs.
Phase IV—Additional post-marketing testing of drugs sometimes
required by FDA.
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premenstrual syndrome
(PMS)/premenstrual dysphoric
disorder (PMDD) —PMS refers to
the variation of physical and mood
symptoms that appear during the
last one or two weeks of the menstrual cycle and disappear by
the end of a full flow of menses.
Psychiatrists and other mental health
workers tend to use the term PMDD
to describe a specific set of mood
symptoms that interfere with social
or role functioning that are also
present the week before menses
and remit a few days after the start.
PMS looks more at physical symptoms such as bloating, breast
tenderness and appetite change.
PMDD has as part of its definition
symptoms such as depressed mood,
anxiety or tension, irritability,
concentration difficulties, overeating or food cravings, and feeling
overwhelmed.
psychosis—Severe mental disorders in which the individual loses
contact with reality. Symptoms
include delusions, hallucinations,
thought disorders, loss of emotion,
mania and depression.
schizophrenia—The most common
form of psychotic illness characterized by disturbances in thinking,
emotional reaction and behavior.
It is disabling and has a prolonged
course that almost always results
in chronic ill health and some
degree of personality change.
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SELECTED FACTS ABOUT MENTAL ILLNESSES
ADDICTIVE DISORDERS
AND
Overview
• Hundreds of millions of people worldwide are affected by mental, behavioral, neurological, and substance use
disorders. In 2002, the World Health Organization (WHO) estimated that globally 154 million people suffered
from depression and 25 million from schizophrenia. Another 91 million people were affected by alcohol use
disorders and 15 million by drug use disorders. WHO also estimates that 24 million people suffer from
Alzheimer’s disease and other dementias.1
• An estimated 26.2 percent of Americans ages 18 and older—about one in four adults—suffer from a diagnosable
mental disorder in a given year. When applied to the 2004 U.S. Census residential population estimate for ages
18 and older, that figure translates to 57.7 million people. Mental disorders are the leading cause of disability in
the United States and Canada for ages 15-44. Many people suffer from more than one mental disorder at a given
time. Nearly half (45 percent) of those with any mental disorder meet the criteria for two or more disorders.2
• Mental illness, including suicide, accounts for more than 15 percent of the burden of disease in established
market economies, which is more than the disease burden caused by all cancers.2 Worldwide, about 877,000
people die by suicide every year.1
• In 2006, suicide was the eleventh leading cause of death in the United States, accounting for 33,300 deaths. The
overall rate was 10.9 suicide deaths per 100,000 people. An estimated 12 to 25 attempted suicides occur per
every suicide death. Suicide was the seventh leading cause of death for males and the sixteenth leading cause
of death for females in 2006. Almost four times as many males as females die by suicide.2
• Serious mental illnesses cost the United States more than $317 billion in lost wages, health care expenditures
and disability benefits each year.2
Addictive Disorders
• Substance abuse affects an estimated 25 million Americans, and another 40 million people, such as families of
abusers and those injured or killed by intoxicated drivers, are affected indirectly. Alcoholism afflicts 10 million
adults and 3 million children. An estimated 12.5 million Americans are addicted to other drugs, such as barbiturates, opiates, sedatives, and hallucinogens.3
• The estimated economic cost of alcohol abuse in 1998 was $184.6 billion, or $638 for every man, woman, and
child in the United States. Alcohol-related injuries alone cost an estimated $47 billion annually.4
• The Office of National Drug Control Policy reported that in 2002, the economic cost of drug abuse to the United
States was $180.9 billion.5
Alzheimer’s Disease/Dementias 6
• Today, 5.3 million people are living with Alzheimer’s—every 70 seconds, someone develops the disease. Some
5.1 million people with Alzheimer’s are age 65 and older, but an estimated 500,000 people younger than age
65 either have Alzheimer’s or another dementia.
• Alzheimer’s disease is the most common type of dementia, accounting for 60 percent to 80 percent of cases.
Vascular dementia (also called multi-infarct dementia, post-stroke dementia, or vascular cognitive impairment)
is considered the second most common type after Alzheimer’s.
• In 2000, an estimated 411,000 new cases of Alzheimer’s were diagnosed. That number was expected to
increase to 454,000 new cases a year by 2010; 615,000 annually by 2030; and 959,000 new cases a year by
2050. By that year, the number of people age 65 and older with Alzheimer’s could be as high as 16 million
unless researchers find a way to prevent or treat the disease.
• In 2006, Alzheimer’s was listed as the “underlying cause of death” for 72,432 Americans. In 1991, only 14,112
death certificates recorded Alzheimer’s as the underlying cause. From 2000-2006, deaths from Alzheimer’s
increased by 46.1 percent, while the number one cause of death, heart disease, decreased by 11.1 percent. In
2006, Alzheimer’s was the seventh leading cause of death for people of all ages and the fifth in people age 65
and older.
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SELECTED FACTS ABOUT MENTAL ILLNESSES
ADDICTIVE DISORDERS
AND
Alzheimer’s Disease/Dementias 6 (continued)
• Some 70 percent of people with Alzheimer’s and other dementias live at home, where they are cared for by
family and friends. In 2009, nearly 11 million family members and friends provided an average of 21.9 hours of
unpaid care per week for a person with Alzheimer’s disease or another dementia, for a total of about 12.5 billion
hours of care. That year, the estimated economic value of the unpaid care was $144 billion. About 60 percent of
family and other unpaid caregivers of people with Alzheimer’s disease and other dementias are women.
• People with Alzheimer’s disease and other dementias are high users of health care, long-term care and hospice.
Total payments for these types of care from all sources, including Medicare and Medicaid, are three times higher
for older people with Alzheimer’s and other dementias than for other older people. Based on the average per
person payments from all sources for health care and long-term care services for people aged 65 and older with
Alzheimer’s disease and other dementias in 2004, total payments for 2010 are expected to be $172 billion,
including $123 billion for Medicare and Medicaid.
Anxiety Disorders 2
• Anxiety disorders, which include panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder,
generalized anxiety disorder, and phobias, affect some 40 million adults ages 18 and older, or about 18.1 percent
of people in this age group in a given year.
• About 6.8 million American adults ages 18 and older, or about 3.1 percent of people in this age group, have
generalized anxiety disorder (GAD) each year. The median age of onset is 31.
• Some 2.2 million U.S. adults age 18 and older, or about 1 percent of people in that age group, have obsessivecompulsive disorder (OCD) in a given year. The median age of onset is 19.
• Approximately 6 million Americans ages 18 and older have panic disorder, or about 2.7 percent of people in
that age group.
• About 7.7 million U.S. adults age 18 and older, or about 3.5 percent of that age group, have post-traumatic
stress disorder (PTSD), in a given year. PTSD can develop at any age, but the median age of onset is 23.
• About 15 million American adults ages 18 and older, or about 6.8 percent of people in this age group, have
social phobia yearly. The disorder typically begins around age 13.
Attention-Deficit/Hyperactivity Disorder (ADHD)
• Attention-deficit/hyperactivity disorder (ADHD) is one of the most common reasons children are referred for
mental health services. It affects as many as one in every 20 children, and boys are three to four times more
likely than girls to experience the disorder.3
• ADHD usually becomes evident in preschool or early elementary years. The median age of onset is seven years,
although the disorder can persist into adolescence and occasionally into adulthood.2 Although most children with
ADHD have normal or above-normal intelligence, 40 percent to 60 percent have serious learning difficulties.3
Autism 2
• (Estimating the prevalence of autism is difficult and controversial due to differences in the ways that cases are
identified and defined, differences in study methods, and changes in diagnostic criteria.) A recent study reported
the prevalence of autism among 8-year-olds to be about 1 in 110. Autism and other autism spectrum disorders
(ASDs) develop in childhood and generally are diagnosed by age three.
• Autism is about four times more common in boys than girls; however, girls with the disorder tend to have more
severe symptoms and greater cognitive impairment.
Depression
• Mood disorders, which include major depressive disorder, dysthymic disorder, and bipolar disorder, affect
nearly 21 million U.S. adults, or about 9.5 percent of the U.S. population age 18 and older in a given year. The
median age of onset for mood disorders is age 30. These disorders often co-occur with anxiety disorders and
substance abuse.2
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SELECTED FACTS ABOUT MENTAL ILLNESSES
ADDICTIVE DISORDERS
AND
Depression (continued)
• Bipolar disorder affects about 5.7 million American adults, or about 2.6 percent of the U.S. population age 18
and older yearly. The median age of onset for this disorder is age 25.2
• Dysthymic disorder (chronic, mild depression) affects some 1.5 percent of the U.S. population age 18 and older
(about 3.3 million people) in a given year. The median age of onset is 31.2
• Major depressive disorder is the leading cause of disability in the United States for ages 15-44, affecting nearly
15 million American adults (about 6.7 percent of the U.S. population age 18 and older) in a given year. The disorder can develop at any age, but the median age at onset is 32. Major depressive disorder is more prevalent in
women than in men.2
• Clinical depression has become one of America’s most costly illnesses. Left untreated, depression is as costly as
heart disease or AIDS to the U.S. economy, costing more than $43.7 billion in absenteeism from work (more
than 200 million days lost from work each year), lost productivity and direct treatment costs. Depression tends to
affect people in their prime working years and may last a lifetime if untreated. More than 80 percent of people
with clinical depression can be successfully treated.3
Eating Disorders
• In their lifetime, an estimated 0.6 percent of the adult population in the United States will suffer from anorexia,
1.0 percent from bulimia, and 2.8 percent from a binge-eating disorder. Women are much more likely than
males to develop an eating disorder. They are three times as likely to experience anorexia (0.9 percent of women
vs. 0.3 percent of men) and bulimia (1.5 percent of women vs. 0.5 percent of men). They are also 75 percent
more likely to have a binge-eating disorder (3.5 percent of women vs. 2.0 percent of men).2
• The mortality rate among people with anorexia has been estimated at 0.56 percent per year, or approximately
5.6 percent per decade, which is about 12 times higher than the annual death rate due to all causes of death
among females ages 15-24 in the general population.2
• An estimated 32.7 percent of U.S. adults 20 years and older are overweight, 34.3 percent are obese, and 5.9
percent are extremely obese. Compared with whites, African Americans have a 51 percent higher prevalence
rate of obesity and Hispanics have a 21 percent higher rate.7
• In 2004, the U.S. Centers for Disease Control and Prevention (CDC) ranked obesity as the number one health
risk facing America. Obesity causes an estimated 400,000 deaths a year and costs the national economy nearly
$122.9 billion annually.8
Premenstrual Disorders
• Premenstrual syndrome (PMS) is estimated to affect up to 75 percent of women during their childbearing years.
It occurs more often in women between their late 20s and early 40s, those with at least one child, those with a
family history of a major depressive disorder, or women with a past medical history of either postpartum depression or an affective mood disorder. Up to 60 percent of women with severe PMS have an underlying psychiatric
disorder.9
• Premenstrual dysphoric disorder (PMDD), a very severe form of PMS, affects about 5 percent of menstruating
women.10
Schizophrenia
• Schizophrenia strikes some 2.4 million American adults, or about 1.1 percent of the U.S. population age 18 and
older, in a given year, affecting men and women with equal frequency. The disorder first appears in men in their
late teens or early 20s, while women are generally affected in their 20s or early 30s.2
• The appearance of schizophrenic symptoms before age 12 is rare—less than one-sixtieth as common as the
adult-onset type. Neurodevelopmental damage seems to be greater in childhood schizophrenia than in the adultonset type. Most schizophrenic children show delays in language and other functions long before their psychotic
symptoms (hallucinations, delusions, and disordered thinking) appear, usually at age seven or later. In the first
years of life, about 30% of these children have transient symptoms of pervasive developmental disorder, such as
rocking, posturing, and arm flapping.3
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SELECTED FACTS ABOUT MENTAL ILLNESSES
ADDICTIVE DISORDERS
AND
Schizophrenia (continued)
• Schizoaffective disorder, a combination of symptoms of schizophrenia and a mood disorder, may range from
two to five in 1,000 people (i.e., 0.2 percent to 0.5 percent) and may account for one-fourth or even one-third of
all people with schizophrenia.11
Sources:
1. World Health Organization, www.who.int
2. National Institute of Mental Health, www.nimh.nih.gov
3. Mental Health America, www.mentalhealthamerica.net, www.nmha.org
4. Community Safety Series, www.be-safe.org
5. U.S. Department of Justice, www.usdoj.gov
6. Alzheimer’s Association, www.alz.org
7. Centers for Disease Control and Prevention, www.cdc.gov
8. ObesityinAmerica.org, (The Endocrine Society and The Hormone Foundation), www.obesityinamerica.org
9. National Library of Medicine, www.nlm.nih.gov
10. Madison Institute of Medicine, Inc., www.pmdd.factsforhealth.org
11. National Alliance on Mental Illness, www.nami.org
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T H E D R U G D I S C O V E RY, D E V E L O P M E N T
AND
APPROVAL PROCESS
It takes 10-15 years on average for an experimental drug to travel from the lab to U.S. patients. Only five in 5,000
compounds that enter preclinical testing make it to human testing. One of these five tested in people is approved.
Clinical Trials
Phase
II
Phase
III
FDA
Years
6.5
1.5
2
3.5
1.5
Test
Population
Laboratory and
animal studies
20 to 100
healthy
volunteers
100 to 500
patient
volunteers
1,000 to 5,000
patient
volunteers
Determine
safety
and
dosage
Evaluate
effectiveness,
look for
side effects
Confirm effectiveness,
monitor adverse
reactions from
long-term use
Assess safety,
biological
activity and
formulations
Purpose
Success
Rate
5
enter trials
5,000
compounds evaluated
THE DRUG DEVELOPMENT
T
he U.S. system of new drug approvals is perhaps
the most rigorous in the world.
It takes 10-15 years, on average, for an experimental
drug to travel from lab to U.S. patients, according to
the Tufts Center for the Study of Drug Development,
based on drugs approved from 1994 through 1998.
Only five in 5,000 compounds that enter preclinical
testing make it to human testing. And only one of those
five is approved for sale.
On average, it costs a company $1.3 billion to get
one new medicine from the laboratory to U.S. patients,
according to a 2007 study by the Tufts Center for the
Study of Drug Development.
Once a new compound has been identified in the
laboratory, medicines are developed as follows:
Preclinical Testing. A pharmaceutical company conducts laboratory and animal studies to show biological
activity of the compound against the targeted disease,
and the compound is evaluated for safety.
Investigational New Drug Application (IND). After
completing preclinical testing, a company files an IND
with the U.S. Food and Drug Administration (FDA) to
begin to test the drug in people. The IND shows results
of previous experiments; how, where and by whom
the new studies will be conducted; the chemical
structure of the compound; how it is thought to work
in the body; any toxic effects found in the animal
studies; and how the compound is manufactured. All
clinical trials must be reviewed and approved by the
Institutional Review Board (IRB) where the trials will
be conducted. Progress reports on clinical trials must
be submitted at least annually to FDA and the IRB.
Clinical Trials, Phase I. These tests usually involve
about 20 to 100 normal, healthy volunteers. The tests
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AND
File NDA/BLA at FDA
Phase
I
File IND at FDA
Discovery/
Preclinical Testing
Review
process/
approval
Phase
IV
Additional
postmarketing
testing
required
by FDA
1
approved
APPROVAL PROCESS
study a drug’s safety profile, including the safe dosage
range. The studies also determine how a drug is
absorbed, distributed, metabolized, and excreted as
well as the duration of its action.
Clinical Trials, Phase II. In this phase, controlled
trials of approximately 100 to 500 volunteer patients
(people with the disease) assess a drug’s effectiveness
and determine the early side effect profile.
Clinical Trials, Phase III. This phase usually involves
1,000 to 5,000 patients in clinics and hospitals.
Physicians monitor patients closely to confirm efficacy
and identify adverse events.
New Drug Application (NDA)/Biologic License
Application (BLA). Following the completion of all
three phases of clinical trials, a company analyzes all
of the data and files an NDA or BLA with FDA if the
data successfully demonstrate both safety and effectiveness. The applications contain all of the scientific
information that the company has gathered.
Applications typically run 100,000 pages or more.
The average review time for the 25 new therapeutics
approved by the FDA in 2009 was 13.3 months.
Approval. Once FDA approves an NDA or BLA, the
new medicine becomes available for physicians to
prescribe. A company must continue to submit periodic
reports to FDA, including any cases of adverse reactions
and appropriate quality-control records. For some
medicines, FDA requires additional trials (Phase IV) to
evaluate long-term effects.
Discovering and developing safe and effective new
medicines is a long, difficult, and expensive process.
Pharmaceutical companies invested an estimated
$65.3 billion in research and development in 2009.
Mental Illnesses 2010
31
TRACKING THE PHARMACEUTICAL AND
BIOTECHNOLOGY RESEARCH PIPELINES
Today, more than 2,900 new medicines are in development in the United States. Many of these potential
new medicines will fail in clinical trials, but some
may represent tomorrow’s new treatments. Bringing
each new medicine to patients will require, on
average, 10 to 15 years of testing and review.
PhRMA publishes several reports that track the
pharmaceutical and biotechnology research pipelines
for many diseases, including the leading causes of
death among Americans—heart disease, cancer, and
stroke. The reports include medicines currently in
clinical trials or at the U.S. Food and Drug
Administration (FDA) for review. Below is a summary
of our most popular reports.
• Cancer—There are few things that cause patients
more fear and uncertainty as a cancer diagnosis.
Yet today—because of a steady stream of new and
improved medicines and treatments—cancer can
increasingly be managed and even beaten. The
2009 report found 861 medicines in the pipeline.
• Heart Disease and Stroke—Keeping up the
momentum of drug discovery that has helped cut
deaths from heart disease and stroke in half in the
past three decades, biopharmaceutical companies
are working on new medicines for these diseases.
The 2009 report found 312 medicines in the
pipeline.
• Diabetes—Approximately 4,110 people are diagnosed with diabetes every day. To help fight this
disease, pharmaceutical and biotechnology
researchers are working on new medicines to treat
it and related conditions. The 2010 report found
235 medicines in the pipeline.
• Mental Illnesses—Pharmaceutical and biotechnology researchers are testing many new medicines to help the more than 450 million people
worldwide who suffer from some form of mental
illness. The 2010 report found 313 medicines in
the pipeline.
• Biotechnology—Millions of people have already
benefited from medicines and vaccines developed
through biotechnology, and a new report offers
hope that many more will benefit in the future. The
2008 report found 633 medicines in the pipeline.
• Children—Biopharmaceutical researchers are
testing medicines to meet the special needs of children. These medicines offer hope that the
significant improvements achieved in children’s
health over the past few decades will continue and
even accelerate. The 2010 report found 234 medicines in clinical trials.
• Older Americans—The population of Americans
over 65 is surging, and the pace will only increase
over the coming years. As life expectancy continues to expand, older Americans face new and
growing challenges to their health, productivity and
independence. The 2008 report found 1,026 medicines in the pipeline.
New Medicines. New Hope.®
Pharmaceutical Research and Manufacturers of America
950 F Street, NW
Washington, DC 20004
www.phrma.org | www.innovation.org | www.pparx.org | www.buysafedrugs.info | www.sharingmiracles.com
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