Health Canada Approves Otsuka and Lundbeck's (Pr)ABILIFY ASIMTUFII® (aripiprazole), the First-and-Only, Once-Every-Two-Months, Long-Acting Injectable (LAI) Treatment for Schizophrenia and for Main...
MONTREAL, Jan. 20, 2025 /CNW/ - Otsuka Pharmaceutical Canada Inc. (Otsuka) and Lundbeck Canada Inc. (Lundbeck) announce that Health Canada has issued a Notice of Compliance for ABILIFY ASIMTUFII® (aripiprazole prolonged release injectable suspension) for intramuscular use, a once-every-two-months treatment for schizophrenia and maintenance monotherapy of bipolar I disorder in adults.
ABILIFY ASIMTUFII is the longest long-acting injectable (LAI) that may be used without the need to establish treatment adequacy with a shorter-acting LAI. It offers two months of sustained plasma concentrations with one dose. Each dose is provided in a pre-filled syringe and is administered by a healthcare professional to appropriate patients via intramuscular injection in the gluteal muscle. ABILIFY ASIMTUFII, a long-acting treatment, offers continuous delivery of medication, which may help those living with schizophrenia or bipolar I disorder.
"We are pleased to offer this new treatment option for people living with schizophrenia or bipolar I disorder," said Michael Laranjo, president and general manager at Otsuka Canada. "This approval underscores our commitment to innovate and continuously evolve to meet the needs of the communities we serve."
Howard C. Margolese MD, CM, MSc, FRCPC, commented, "A long-acting injectable formulation of aripiprazole with a 2-month dosing interval will increase the treatment options available for patients suffering from schizophrenia or bipolar I disorder and may reduce burden on patients and clinicians compared with the monthly administration required for aripiprazole once-monthly.''
Mary Alberti, CEO of the Canadian Institute for Advancements in Mental Health (IAM) added, "Access to treatment is key and new long-acting injectable options align to individual patient needs, improving the potential for therapeutic adherence and prevention of relapse." The IAM is a charitable organization supporting individuals, families and communities impacted by serious and complex mental health issues.
Michal Juul Sørensen, vice president and general manager at Lundbeck Canada, added, "This approval is important news for patients, families, and healthcare providers, and we strive to provide our patients with more treatment options and thereby have a positive impact on those living with schizophrenia or bipolar I disorder."
About schizophrenia
Schizophrenia is a severely debilitating mental illness characterized by delusions, hallucinations, and impaired cognition.1,2 Based on a systematic review of global data, the prevalence of schizophrenia in 2019 was estimated to be approximately 0.3% and did not vary widely across countries or regions.3,4 The worldwide lifetime prevalence of the disease has been estimated to be approximately 0.9% across diverse geographic, cultural, and socioeconomic categories. The course of schizophrenia is typically characterized by acute episodes of psychotic behaviours occurring at varying intervals between periods of relative symptomatic stability.1
About bipolar I disorder
Bipolar I disorder is a recurrent, lifelong mood disorder with a variable course that results in functional and cognitive impairment and a reduction in quality of life that affects 0.6% of the population.5,6,7 The course of bipolar I disorder is characterized by recurrent manic and depressive episodes that may last weeks or months.8 Over 90% of people with bipolar disorder experience recurrences during their lifetimes.9
Bipolar I disorder often requires long-term pharmacologic treatment to delay time to recurrence.5 Long-acting injectables have the potential to offer continuous delivery of medication and can provide sustained plasma concentrations, which may help address the episodic nature of bipolar disorder.10
About ABILIFY ASIMTUFII
ABILIFY ASIMTUFII (aripiprazole prolonged release injectable suspension), a once-every-two-months long-acting injectable, is provided in a pre-filled syringe that does not require reconstitution. It is intended to be administered by a healthcare professional once every two months via intramuscular injection in the gluteal muscle in adult patients with schizophrenia or bipolar I disorder.11
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. ABILIFY ASIMTUFII is not indicated in elderly patients with dementia. The safety and efficacy of ABILIFY ASIMTUFII has not been established in pediatric patients and its use is not recommended in this population. For more information about ABILIFY ASIMTUFII, please visit http://otsukacanada.com or https://www.lundbeck.com/ca.
About Otsuka
Otsuka Canada Pharmaceutical Inc. (OCPI) is an innovative, fast-growing healthcare company that commercializes Otsuka medicines in Canada. OCPI aims to improve the quality of life and health of patients through its commitments to neuroscience, cardio-renal, 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. In 2023, the Otsuka group of companies employed approximately 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka on the global website at https://www.otsuka.co.jp/en. Learn more about Otsuka in Canada at www.otsukacanada.com.
About Lundbeck
Since 1995, Lundbeck Canada Inc. has been striving to improve the lives of Canadians living with neurological and psychiatric diseases. As a subsidiary of H. Lundbeck A/S, a global biopharmaceutical company focusing exclusively on brain health, we benefit from more than 70 years being at the forefront of neuroscience research.
As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
We are committed to fighting stigma and we act to improve health equity. We strive to create long-term value for our shareholders by making a positive contribution to patients, their families and society as a whole.
Lundbeck has approximately 5,500 employees in more than 50 countries and our products are available in more than 80 countries.
For additional information, we encourage you to visit our corporate website www.lundbeck.com/ca.
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1 American Psychiatric Association. What Is Schizophrenia. Available at: https://www.psychiatry.org/patients-families/schizophrenia/what-is-schizophrenia. |
2 The National Institute of Mental Health. Schizophrenia. Available at: https://www.nimh.nih.gov/health/topics/schizophrenia. |
3 World Health Organization. Schizophrenia. Available at: https://www.who.int/news-room/fact-sheets/detail/schizophrenia. |
4 The National Institute of Mental Health. Schizophrenia Statistics. Available at: https://www.nimh.nih.gov/health/statistics/schizophrenia. |
5 Bonnín CDM, Reinares M, Martínez-Arán A, et al. Improving Functioning, Quality of Life, and Well-being in Patients With Bipolar Disorder. Int J Neuropsychopharmacol. 2019;22(8):467-477. doi:10.1093/ijnp/pyz018 |
6 Dattani S., Ritchie H., and Roser M. Mental Health. Our World In Data. 2021. |
7 Merikangas KR, Jin R, He JP, et al. Prevalence and Correlates of Bipolar Spectrum Disorder in the World Mental Health Survey Initiative. Arch Gen Psychiatry. 2011;68(3):241-251. doi:10.1001/archgenpsychiatry.2011.12. |
8 The National Institute of Mental Health. Bipolar Disorder. Available at: https://www.nimh.nih.gov/health/topics/bipolar-disorder. |
9 Leelahanaj T, Kongsakon R, Choovanichvong S, et al. Time to Relapse and Remission of Bipolar Disorder: Findings from a 1-year Prospective Study in Thailand. Neuropsychiatr Dis Treat. 2013;9:1249-1256. doi:10.2147/NDT.S47711 |
10 Guzman F. Long-Acting Injectable Antipsychotics: A Summary for Prescribers. Psychopharmacology Institute. 2017. |
11 ABILIFY MAINTENA / ABILIFY ASIMTUFII (aripiprazole) 2025 full Product Monograph. |
SOURCE Otsuka Canada Pharmaceutical Inc.