Health Canada Approves Otsuka and Lundbeck's ABILIFY MAINTENA® (aripiprazole for prolonged release injectable suspension) Alternative Initiation Regimen

MONTREAL, March 3, 2021 /CNW/ - Otsuka Pharmaceutical Canada Inc. (Otsuka) and Lundbeck Canada Inc. (Lundbeck) announce that Health Canada issued a Notice of Compliance for an alternative initiation regimen for ABILIFY MAINTENA® (aripiprazole for prolonged release injectable suspension). Authorization for use of the alternative initiation regimen takes effect immediately.

The new, alternative initiation regimen of two injections of 400 mg ABILIFY MAINTENA at separate gluteal and/or deltoid sites with a single dose of 20 mg oral aripiprazole, all on the first day of treatment, offers a new option for initiating patients onto ABILIFY MAINTENA. The existing approved initiation regimen remains unchanged (one injection of 400 mg ABILIFY MAINTENA at the gluteal or deltoid site followed by 14 consecutive days of treatment with 10 to 20 mg oral aripiprazole or current oral antipsychotic).

"The new alternative initiation regimen minimizes burden on care providers and families, simplifies the initiation process, and potentially reduces length of stay in hospital," said Dr. Andrea Bardell MD, MSc, FRCPC, psychiatrist.

Please note that the alternative injection regimen has no impact on the packaging of ABILIFY MAINTENA.

About Schizophrenia

Schizophrenia is a chronic and severe mental disorder affecting 20 million people worldwide.¹ Schizophrenia is characterized by distortions in thinking, perception, emotions, language, sense of self and behaviour. Worldwide, schizophrenia is associated with considerable disability and may affect educational and occupational performance. Stigma, discrimination and violation of human rights of people with schizophrenia is common.

About Bipolar

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

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 and was approved for the treatment of bipolar I disorder 1 in 2017. ⁵   

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.

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).

The starting dose can be administered using one of two regimens:

• One-injection start: On the day of treatment initiation, administer one injection of 400 mg of ABILIFY MAINTENA. After the first ABILIFY MAINTENA injection, treatment should be continued with 10 mg to 20 mg oral aripiprazole or current oral antipsychotic for 14 consecutive days to maintain therapeutic antipsychotic concentrations during initiation of therapy. Administer the next monthly 400 mg single injection no sooner than 26 days after the previous injection.
• Two-injection start: On the day of treatment initiation, administer two separate injections of 400 mg ABILIFY MAINTENA at separate injection sites , along with one 20 mg dose of oral aripiprazole. Administer the next monthly 400 mg single injection no sooner than 26 days after the previous injection. The recommended maintenance dose of ABILIFY MAINTENA is 400 mg. ABILIFY MAINTENA should be administered by a healthcare professional once monthly as a single injection no sooner than 26 days after the previous injection. ABILIFY MAINTENA is not indicated in elderly patients with dementia. ABILIFY MAINTENA is not indicated in pediatric patients and its use is not recommended in this population. For more information about ABILIFY MAINTENA, please visit http://otsukacanada.com.

ABILIFY MAINTENA^® is a trademark of Otsuka Pharmaceutical Co., Ltd., used under license by Otsuka Canada Pharmaceutical Inc.

About Otsuka 

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 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 Pharmaceutical is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., based in Tokyo, Japan. The Otsuka group of companies employed approximately 47,000 people worldwide and had consolidated sales of approximately USD 13.3 billion in 2020.

All Otsuka stories start by taking the road less travelled. Learn more about Otsuka on our global website at https://www.otsuka.co.jp/en. Learn more about Otsuka in Canada at www.otsukacanada.com.

About Lundbeck 

Lundbeck is a global biopharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.

Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales.

Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centres in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (CAD 3.5 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com/ca/en.  

References

¹ World Health Organization Fact sheet on Schizophrenia (updated October 2019): https://www.who.int/news-room/fact-sheets/detail/schizophrenia

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.

⁵ ABILIFY MAINTENA (aripiprazole) 2021 full product monograph

SOURCE Otsuka Canada Pharmaceutical Inc.

Helena Wade, Hill+Knowlton Strategies, E: [email protected], M: 613-483-7853