Download Sunovion and Takeda Announce Results from a New Study

Contacts:
Patricia Moriarty
Senior Director, Corporate Communications
Sunovion Pharmaceuticals Inc.
+1 508 787 4279
[email protected]
Elissa Johnsen
Director, Product Communications
Takeda Pharmaceuticals International GmbH
+1 224 554 3185
[email protected]
Sunovion and Takeda Announce Results from a New Study Showing Maintenance
Treatment with Lurasidone Reduced the Risk of Relapse in Adults with
Schizophrenia
nd
Study Findings Presented at the 22 European Congress of Psychiatry (EPA 2014) in Munich
Munich, Germany, 3 March 2014 – Sunovion Pharmaceuticals Inc. (“Sunovion”) (Head Office:
Marlborough, Massachusetts) and Takeda Pharmaceutical International GmbH ("Takeda") (Zurich,
Switzerland) today announced the results from a double-blind, placebo-controlled study that
evaluated the efficacy, safety and tolerability of lurasidone for the maintenance treatment of
adults with schizophrenia. Lurasidone is a once-daily oral atypical antipsychotic indicated for the
treatment of adults with schizophrenia and is currently available in the United States, Canada and
Switzerland. The Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) issued a Positive Opinion for lurasidone for the treatment of
schizophrenia in adults on January 23, 2014.
In the double-blind, placebo-controlled, randomized withdrawal study, adult patients with
schizophrenia who were stabilized on lurasidone (40-80 mg/day, flexibly dosed) during open-label
treatment were randomized to either continued treatment with lurasidone (40 mg/day or 80
1
mg/day, flexibly dosed) or placebo for up to 28 weeks. The primary endpoint was time to relapse
over 28 weeks of the double-blind phase. The study showed that patients who received
lurasidone (N=144) experienced a significant delay in time to relapse compared to patients who
1
received placebo (N=141) (p=0.039). Treatment with lurasidone was associated with a 33.7%
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reduction in risk of relapse vs. placebo (hazard ratio 0.663, 95% CI [0.447, 0.983]; p=0.041).
The study demonstrated that lurasidone was generally well-tolerated and had low rates of weight
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increase, as well as lipid and glucose effects. It is important to minimize the adverse effects on
long-term physical health of schizophrenia as patients are likely to remain on therapy for many
years.
The discontinuation rate due to adverse events during the double-blind phase in patients treated
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with lurasidone was 13.9% vs. 15.6% for placebo. In patients who completed the open-label
stabilization phase (12 to 24 weeks) and were randomized to continued treatment with lurasidone
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in the double-blind phase (up to 28 weeks), the most common treatment-emergent adverse
events (incidence >10%) were akathisia (16.7%), insomnia (12.5%), headache (11.8%), nausea
(11.1%) and anxiety (11.1%).
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“Schizophrenia is a chronic condition that is severe and disabling, so it is important that
healthcare providers not only address the acute symptoms of the illness, but also minimize the
risk of experiencing relapse, a common challenge with the disorder,” said Rajiv Tandon, M.D.,
Vice Chair and Professor of Psychiatry at the University of Florida College of Medicine, Chief of
Psychiatry at the North Florida/South Georgia Veterans Health System, Florida, United States
and lead author on the study. “This study supports the efficacy of lurasidone in preventing relapse
while producing few changes in weight, lipids and measures of glycemic control.”
These data were submitted to the EMA for potential inclusion in the Summary of Product
Characteristics. These study results will also be submitted to relevant Health Authorities for
review and potential inclusion in the respective prescribing information.
“Lurasidone has demonstrated efficacy and safety in a number of short-term studies of adults with
schizophrenia,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at
Sunovion Pharmaceuticals Inc. “We are pleased to see the results of this study confirm the longterm efficacy of lurasidone in schizophrenia. In addition, long-term effects on metabolic
parameters were consistent with the findings of short-term studies.”
About Schizophrenia
Schizophrenia is a chronic, serious and often severely disabling brain disorder that affects
3
approximately 24 million people worldwide. Schizophrenia is characterized by symptoms such
as hallucinations, delusions, disorganized thinking, lack of emotion and lack of energy, as well as
4
problems with memory, attention and the ability to plan, organize and make decisions. Patients
with schizophrenia have a life span that is decreased by approximately 10–22.5 years compared
with the general population.
5,6,7,8
Direct and indirect costs associated with caring for patients with schizophrenia are considerable
and can include utilization of other health services, pharmacotherapy, community care, supportive
therapy, informal care and private expenditures, and patient and caregiver lost productivity.
9,10
Hospitalization associated with patient relapse can significantly increase costs associated with
disease management in schizophrenia.
11
Antipsychotics are considered to be the cornerstone of treatment for patients with schizophrenia,
with agents generally classified as typical or atypical. Atypical agents are broadly considered to
have safety and tolerability benefits over typical agents.
12
Long-term and maintenance treatment
of schizophrenia remains challenging due to multiple problems related to compliance, efficacy,
13
safety and tolerability, which vary among different medications.
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About Lurasidone
Lurasidone is an atypical antipsychotic developed originally by Dainippon Sumitomo Pharma Co.,
Ltd. The efficacy of lurasidone may be mediated through a combination of central dopamine Type
2 (D2) and serotonin Type 2 (5HT2A) receptor antagonism.
®
Lurasidone, marketed as Latuda , is approved for the treatment of schizophrenia in the United
States, Canada and Switzerland.
The CHMP of the EMA issued a Positive Opinion for lurasidone for the treatment of schizophrenia
in adults on January 23, 2014.
A marketing application has been filed for lurasidone with the Australian Therapeutic Goods
Administration and the Taiwan Food and Drug Administration.
About Sunovion Pharmaceuticals Inc. (Sunovion)
Sunovion is a leading pharmaceutical company dedicated to discovering, developing and
commercializing therapeutic products that advance the science of medicine in the Psychiatry,
Neurology and Respiratory disease areas and improve the lives of patients and their families.
Sunovion’s drug development program, together with its corporate development and licensing
®
efforts, has yielded a portfolio of pharmaceutical products including Latuda (lurasidone HCl)
®
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tablets, Lunesta (eszopiclone) tablets, Xopenex (levalbuterol HCI) inhalation solution, Xopenex
®
HFA (levalbuterol tartrate) inhalation aerosol, (arformoterol tartrate) inhalation solution,
®
®
®
Omnaris (ciclesonide) nasal spray, Zetonna (ciclesonide) nasal aerosol and Alvesco
(ciclesonide) inhalation aerosol.
Sunovion is an indirect, wholly-owned U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd.
In March 2011, Dainippon Sumitomo Pharma Co., Ltd. and Takeda signed a Development and
Commercialization Agreement of the oral formulation of lurasidone hydrochloride for the joint
development and exclusive commercialization by Takeda in the 26 member states of the
European Union at that time (excluding the United Kingdom), Switzerland, Norway, Turkey and
Russia. Upon approval, Sunovion Pharmaceuticals Europe Ltd. will commercialize lurasidone in
the United Kingdom.
More information about Sunovion Pharmaceuticals Inc. is available at www.sunovion.com.
About Takeda Pharmaceutical International GmbH
Takeda Pharmaceuticals International GmbH, headquartered in Zurich, is a wholly owned
subsidiary of Takeda Pharmaceutical Company Limited. As the largest pharmaceutical company
in Japan and a leader in the global industry, Takeda’s mission is to strive toward better health for
patients worldwide through leading innovation in medicine. It has a commercial presence
covering more than 70 countries, with particular strength in Asia, North America, Europe and fastgrowing emerging markets including Latin America, Russia-CIS and China. Takeda is ranked
12th by global Rx sales, 14th in the BRIC countries and 18th in Europe. Takeda’s commercial
presence mainly covers the therapeutic areas of metabolic diseases, gastroenterology, oncology,
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cardiovascular health, CNS diseases, inflammatory and immune disorders, respiratory diseases
and pain management. Additional information about Takeda is available through its corporate
website, www.takeda.com.
For a copy of this release, visit Sunovion’s web site at www.sunovion.com
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References
1. Tandon R et al. A Double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the
maintenance of efficacy in patients with schizophrenia. EPA Congress Abstract, 2014.
2. Sunovion data on file
3. European Brain Council. Schizophrenia Fact Sheet. Available at:
http://www.europeanbraincouncil.org/pdfs/Documents/Schizophrenia%20fact%20sheet%20July%202011.pd
f. Accessed February 3, 2014.
4. NAMI, Schizophrenia. Available at:
http://www.nami.org/Template.cfm?Section=By_Illness&Template=/TaggedPage/TaggedPageDisplay.cfm&
TPLID=54&ContentID=23036. Accessed May 15, 2013.
5. Healy D et al. Mortality in schizophrenia and related psychoses: data from two cohorts, 1875–1924 and
1994–2010. BMJ Open 2012;2:e001810
6. Chang C-K et al. Life Expectancy at Birth for People with Serious Mental Illness and Other Major
Disorders from a Secondary Mental Health Care Case Register in London. PLoS One 2011;6:e19590
7. Laursen TM. Life expectancy among persons with schizophrenia or bipolar affective disorder. Schizophr
Res 2011;131:101–4
8. Tiihonen J et al. 11 year-follow up of mortality in patients with schizophrenia: a population-based cohort
study (FINN11 study). Lancet 2009;374:620–7
9. Salize HJ et al. Cost of schizophrenia in six European countries. Schizophr Res 2009;111(1–3):70–7.
10. Mangalore R and Knapp R. Cost of schizophrenia in England. J Ment Health Policy Econ 2007;10(1):23–
41.
11. Zeidler J et al. The costs of schizophrenia and predictors of hospitalisation from the statutory health
insurance perspective. Health Econ Rev 2012;2(1):9.
12. Lewis DA and Lieberman JA. Neuron 2000;28:325–34.
13. Barnes Thomas RE et al. Evidence-based guidelines for the pharmacological treatment of
schizophrenia: recommendations from the British Association for Psychopharmacology. J Psychopharmacol
(2011) 25 (5): 567-620.
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