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Product News
A new once-daily, higher dose
Aricept® (donepezil HCl) 23-mg
tablet has been approved
by the U.S. Food and Drug
Administration for the
treatment of moderate-tosevere Alzheimer’s disease
(AD).
On the basis of the
approved label, the recommended starting dosage of Aricept is 5 mg once daily and can be
increased to 10 mg once daily after 4
to 6 weeks. Patients with moderateto-severe AD who are established
on a regimen of Aricept 10 mg for
at least 3 months are candidates for
dosage escalation to 23 mg.
The approval of Aricept 23 mg is
based on data from a large head-tohead, randomized, double-blind,
controlled, parallel-group clinical study of Aricept 23 mg versus
Aricept 10 mg in 1,467 patients
with moderate-to-severe AD who
had been treated for 3 months or
more with Aricept 10 mg. Two
co-primary endpoints were examined: the Severe Impairment Battery
(SIB), which measures cognition,
and the Clinician’s Interview-Based
Impression of Change Plus Caregiver Input (CIBIC+), which measures
global function. Aricept 23 mg demonstrated a statistically significant
improvement in cognition but did
not achieve statistically significant
improvement in global function, as
compared with Aricept 10 mg tablet.
The change in total scores from
baseline to Week 24 on the SIB was
2.6 points in the Aricept 23 mg
group compared with 0.4 points in
the 10 mg group, resulting in a sta
tistically significant treatment difference. This was based on data from
the intent-to-treat (ITT) population
(n = 1,371 patients, p = 0.0001), with
similar results for an analysis using
data from the 1,084 patients who
finished the study.
For the CIBIC+, the overall
change score at Week 24 was 4.23 in
the Aricept 23 mg group compared
with 4.29 in the 10 mg group (ITT,
p = 0.1789), but this difference was
not statistically significant.
Source. “Eisai Inc. and Pfizer Inc. Announce U.S. FDA Approval for New HigherDose Aricept (Donepezil HCl) 23 mg Tablet
for the Treatment of Moderate-to-Severe Alzheimer’s Disease.” (2010, July 24). Retrieved
August 20, 2010, from http://www.eisai.com/
view_press_release.asp?ID=147&press=280.
New Labeling on
Injectable Drugs to
Benefit Patient Safety
© U.S. Pharmacopeial Convention
© Pfizer Inc.
Higher-Dose Alzheimer’s
Drug Gets FDA Approval
To reduce the
likelihood of
patient death and
disability resulting from errors
in the administration of injectable medications
in hospitals and other health care
settings, the U.S. Pharmacopeial
Convention (USP), the official standards-setting body for medicines
and their ingredients in the United
States, is advancing new labeling
requirements that will standardize
the information permitted on the
highly visible area of these vials to
only cautionary statements intended
to prevent imminent life-threatening
situations. For medications in which
no cautionary statement is nec-
essary, this area of the vial will be required to remain blank, precluding
company logos, company names,
and other information from being
printed in these locations.
Reports from the Institute of
Medicine, the National Coordinating Council for Medication Error
Reporting and Prevention, the
Institute for Safe Medication Practices, and others have indicated that
labeling of injectable products may
be linked to medication errors in the
administration of these products.
Patient safety data from U.S. hospitals have indicated that the most
severe medication errors for injectable products were predominantly
related to human performance
deficits, occurring most often at the
time of administration, with environmental distractions as the major
contributing factor.
The new requirements apply to the
top (circle) surface of the ferrule and
cap overseal of a vial containing an injectable medication. According to the
U.S. Food and Drug Administration
(FDA), if manufacturers believe they
need to include a cautionary statement
about an imminent life-threatening
situation on the ferrule or cap overseal
of their product, manufacturers will
need to provide a rationale to FDA
for why the situation addressed in
the statement is considered to be life
threatening. Other information will
still be permitted to appear elsewhere
on the medication vials.
Source. “New Standard for Labeling
on Injectable Medications Designed to Reduce Likelihood of Patient Death, Disability.” (2010, August 4). Retrieved August 19,
2010, from http://www.eurekalert.org/pub_
releases/2010-08/up-nsf080410.php.
Continued on page 29.
Copyright © SLACK Incorporated
Product News
Continued from page 8.
A study comparing tapentadol
extended release (ER) tablets, an
investigational pain medication, to
an existing prescription pain medication, oxycodone controlled release
(CR) tablets found tapentadol ER
was associated with a lower overall
incidence of gastrointestinal adverse
events than oxycodone CR (tapentadol ER, 52%; oxycodone CR,
64.1%) in patients with chronic knee
or hip osteoarthritis pain or chronic
low back pain.
In this Phase III open-label study,
published in Pain Practice, the
median duration of treatment was
substantially longer with tapentadol
ER (268 days) than with oxycodone
CR (59 days), and the incidence of
overall gastrointestinal treatmentemergent adverse events leading to
study discontinuation was approximately 2.5 times greater in the
oxycodone CR group than in the
tapentadol ER group (oxycodone
CR, 21.5%; tapentadol ER, 8.6%).
The study also found tapentadol
ER provided sustainable relief of
moderate to severe chronic knee or
hip osteoarthritis pain or chronic
low back pain for up to 1 year.
At baseline, mean pain intensity
scores in the tapentadol ER and
oxycodone CR groups were 7.6
and 7.6, respectively; at endpoint,
they had decreased to 4.4 and 4.5.
This study of tapentadol ER
examined its long-term safety and
tolerability compared with oxycodone CR, and the primary objective
was to evaluate the safety of twicedaily dosages of tapentadol ER (100
mg to 250 mg) over 1 year. Patients
The U.S. Food and Drug Administration (FDA) has approved
Tribenzor™ (olmesartan medoxomil,
amlodipine, hydrochlorothiazide), a
new three-in-one, once-daily combination product for the treatment of
hypertension in patients whose condition is not adequately controlled
on any two of the following antihypertensive drug classes: angiotensin
receptor blockers, calcium channel blockers, and diuretic agents. Tribenzor is not indicated for initial therapy.
Tribenzor combines three widely prescribed antihypertensive medications: the complementary actions of olmesartan medoxomil (which
blocks angiotensin II receptors), amlodipine (which inhibits the entrance
of calcium into the blood vessel walls), and hydrochlorothiazide (a diuretic agent that reduces water volume in the blood).
After 8 weeks of treatment, Tribenzor produced highly statistically
significantly greater reductions in both systolic and diastolic blood
pressures compared with each of the three dual combination therapies. According to the Tribenzor pivotal registration trial that included
a total of 2,492 patients with hypertension (mean baseline blood
pressure = 168.5/100.9 mm Hg), the switch to Tribenzor 40/10/25 mg
from each of the following three dual combination therapies—amlodipine/hydrochlorothiazide 10/25 mg, olmesartan/hydrochlorothiazide
40/25 mg, and olmesartan/amlodipine 40/10 mg—yielded a further mean
reduction after 8 weeks of treatment in systolic/diastolic blood pressure
of 8.1/5.4 mm Hg, 7.6/5.4 mm Hg, and 8.4/4.5 mm Hg, respectively (p <
0.0001 versus each dual combination therapy).
© Daiichi Sankyo, Inc.
Phase III Study
Shows Promise for
Investigational Chronic
Pain Drug
3-in-1 Combination Gets
FDA Approval for Hypertension
Source. “FDA Approves Tribenzor, A New Three-in-One Combination Product for the
Treatment of High Blood Pressure.” (2010, July 26). Retrieved August 19, 2010, from http://
www.pharmalive.com/News/index.cfm?articleid=719277&categoryid=29.
were randomized in a 4-to-1 ratio
to receive controlled, adjustable,
oral, twice-daily dosages of tapentadol ER (100 mg to 250 mg) or
oxycodone HCl CR (20 mg to 50
mg) in open-label treatment for up
to 1 year. There were 1,117 patients
in the study who received at least
one dosage of study medication (tapentadol ER, n = 894; oxycodone
CR, n = 223). Demographic and
baseline characteristics were similar
in the two treatment groups.
Nucynta® (tapentadol immediate
release) was approved by the U.S.
Food and Drug Administration in
Journal of Gerontological Nursing • Vol. 36, No. 10, 2010
2008 and is available by prescription only for the relief of moderate
to severe acute pain in patients 18
and older. A New Drug Application for tapentadol ER tablets was
submitted to the FDA in December 2009 for the management of
moderate to severe chronic pain in
patients 18 and older.
Source. “Phase 3 Open-Label Study Comparing Tapentadol Extended Release Tablets
to Oxycodone Controlled Release Tablets
Published by Pain Practice.” (2010, July 19).
Retrieved July 28, 2010, from http://www.
drugs.com/news/phase-3-open-label-studycomparing-tapentadol-extended-releaseoxycodone-controlled-release-25617.html.
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