Health Canada issues a Notice of Compliance for ABILIFY MAINTENA, approving a new indication for the maintenance monotherapy treatment of bipolar I disorder in adult patients.
Montreal, Canada, November 2, 2017– 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 the product monograph
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
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.
Otsuka Canada Pharmaceutical Inc.
Lundbeck Canada Inc.
Corporate Communications Specialist
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.