Otsuka Canada Pharmaceutical Inc. and Lundbeck Canada announce
that Health Canada issued a Notice of Compliance for ABILIFY
MAINTENA (aripiprazole for prolonged release injectable
suspension), approving a new indication for the maintenance
monotherapy treatment of bipolar I disorder in adult patients.1
ABILIFY MAINTENA is a once-monthly injectable formulation for
intramuscular use created by Otsuka and co-developed and
co-commercialized with Lundbeck. In a placebo-controlled phase 3
trial, ABILIFY MAINTENA significantly reduced the risk of
recurrence of any mood episode over 52 weeks compared to
placebo.1
“Abilify Maintena is a welcome and much needed option
for treatment of patients with Bipolar 1 disorder. It
addresses important concerns for patients and loved ones such as
balancing efficacy, tolerability, and long term maintenance in an
illness often characterized by recurrence, relapse and adherence”,
said Dr. Ruth Baruch, Medical Director of the Community Mental
Health Programs, Department of Psychiatry, Michael Garron Hospital
and a lecturer at the University of Toronto.
About Bipolar I Disorder
Bipolar I disorder is a recurrent and chronic mental illness
characterized by episodes of mania (unusually high mood and
energized/elated behavior) and depression (very sad, down, or
hopeless periods).2
Bipolar disorder affects almost 30 million people worldwide, and
the estimated lifetime prevalence of bipolar I disorder in Canada
is 0.87%. 3,4
About ABILIFY MAINTENA® (aripiprazole once-monthly)
ABILIFY MAINTENA (aripiprazole for prolonged release injectable
suspension) is an atypical antipsychotic for intramuscular use. It
was created by Otsuka in Japan and has been co-developed and
co-commercialized by the alliance between Otsuka and Lundbeck.
ABILIFY MAINTENA was approved in Canada in 2014 for the treatment
of adults with schizophrenia.1
ABILIFY MAINTENA is a sterile lyophilized powder that when
reconstituted with sterile water for injection, forms a suspension
that can be administered by injection once a month (the initial
injection is accompanied by an overlapping 14-day dosing of oral
antipsychotic treatment). Subsequent doses of ABILIFY MAINTENA
provide uninterrupted medication coverage for up to 30 days.1
Elderly patients with dementia-related psychosis treated with
atypical antipsychotic drugs are at increased risk of death
compared to placebo. ABILIFY MAINTENA is not indicated for the
treatment of elderly patients with dementia. ABILIFY MAINTENA
safety and efficacy have not been established in patients <18 or
≥65 years of age. ABILIFY MAINTENA is contraindicated in patients
with a known hypersensitivity reaction to aripiprazole.
For more information about ABILIFY MAINTENA, please visit:
http://otsukacanada.com/docs/default-source/default-document-library/product-monographs/abilify-maintena-approved-pm-e.pdf?sfvrsn=10
About Otsuka
Otsuka Pharmaceutical Co., Ltd., is a global healthcare company
with the corporate philosophy: “Otsuka – people creating new
products for better health worldwide.” Otsuka
researches, develops, manufactures and markets innovative and
original products, with a focus on pharmaceutical products for the
treatment of diseases and nutraceutical products for the
maintenance of everyday health.
Otsuka Canada Pharmaceutical Inc. (OCPI) is an innovative,
fast-growing health care company that commercializes Otsuka
medicines in Canada. OCPI aims to improve the quality of life
and health of patients through its commitments to neuroscience,
cardiovascular health, oncology and nephrology. OCPI was
established in 2010, with headquarters in Saint-Laurent,
Quebec.
OCPI is part of Otsuka Pharmaceutical Co., Ltd., a wholly owned
subsidiary of Otsuka Holdings Co., Ltd., based in Tokyo, Japan. The
Otsuka group of companies employed 45,000 people worldwide and had
consolidated sales of approximately CAD 14.5 billion (USD 11
billion) in 2016. All Otsuka stories start by taking the road less
travelled.
Learn more about Otsuka Pharmaceutical Company on its global
website at https://www.otsuka.co.jp/en. Learn more about
Otsuka in Canada at www.otsukacanada.com
About Lundbeck
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global
pharmaceutical company specialized in psychiatric and neurological
disorders. For more than 70 years, we have been at the forefront of
research within neuroscience. Our key areas of focus are
Alzheimer's disease, depression, Parkinson's disease and
schizophrenia.
Our approximately 5,000 employees in 55 countries are engaged in
the entire value chain throughout research, development,
manufacturing, marketing and sales. Our pipeline consists of
several late-stage development programs and our products are
available in more than 100 countries. We have production facilities
in Denmark, France and Italy. Lundbeck generated revenue of DKK
15.6 billion in 2016 (EUR 2.1 billion; USD 2.2 billion).
A division of Denmark-based H. Lundbeck A/S, Lundbeck Canada
Inc. has been a trusted source of innovative new treatments for
Canadians since 1995 with headquarters in Montreal. Originally
focused on providing products for the treatment of diseases such as
depression, anxiety, Alzheimer's disease and schizophrenia,
Lundbeck Canada also offers new cancer therapies for the treatment
of chronic lymphocytic leukemia and non-Hodgkin lymphoma. A
patient-focused partner in Canadian health care, Lundbeck Canada's
mission is to improve the quality of life for people living with
brain diseases and cancer.
References
1. ABILIFY MAINTENA® (aripiprazole) 2017 full product
monograph.
2. National Institute of Mental Health. Bipolar disorder.
https://www.nimh.nih.gov/health/topics/bipolar-disorder/index.shtml.
3. Grande I, Berk M, Birmaher B, Vieta E. Bipolar disorder.
Lancet 2016;387(10027):1561-72.
4. McDonald KC, Bulloch AGM, Duffy A, Bresee L, Williams JVA,
Lavorato DH, & Patten SB. Prevalence of Bipolar I and II
Disorder in Canada. Can J Psychiatry. 2015 Mar; 60(3): 151–156.
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Media InquiriesOtsuka Canada Pharmaceutical Inc.Allison
Rosenthal, 514-332-3099General
ManagerAllison.rosenthal@otsuka-ca.comorLundbeck Canada Inc.Stella
Antonaras, 514-554-1549Corporate Communications
Specialiststll@lundbeck.com