Health Canada approves (Pr)ABILIFY ASIMTUFII® (aripiprazole), the first, once-every-two-months, long-acting injectable treatment for schizophrenia

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A nurse preps a patient arm for an injection

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.”

For more information, read the original press release.


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