Health Canada Approves Otsuka and Lundbeck's REXULTI (brexpiprazole) as Adjunctive Treatment of Major Depressive Disorder

Otsuka Pharmaceutical Canada Inc. (Otsuka) and Lundbeck Canada Inc. (Lundbeck) announce that Health Canada issued a Notice of Compliance for REXULTI® (brexpiprazole) for use as an adjunct to antidepressants for the treatment of major depressive disorder (MDD) in adult patients with an inadequate response to prior antidepressant treatments during the current episode.

"Brexpiprazole, is a new option for patients with MDD who require augmentation therapy. Its unique mechanism of action and potential benefits will be a new source of optimism for patients suffering from Depression" said Dr. Diane McIntosh.

"The Mood Disorders Society of Canada (MDSC) welcomes Health Canada's recent decision to approve REXULTI® (brexpiprazole) for the adjunct treatment of Major Depressive Disorder (MDD). For many patients suffering from depression who have not been able to achieve remission with standard treatments, the addition of this innovative and novel treatment offers hope for patients and their families. In a recent study, over 4% of Canadians met the criteria for a major depressive episode, and it is crucially important to have new and innovative treatments to address this health crisis. MDSC is engaged on an ongoing basis in a wide range of projects and initiatives designed to support the inclusion of persons with disabling mental illnesses in Canadian society and has taken a lead proactive role in public policy and program development in many capacities on the national stage." said Dave Gallson, National Executive Director at MDSC.

About Major Depressive Disorder
Major depressive disorder (MDD), commonly referred to as major depression, is a chronic and disabling illness characterized by persistent low mood and markedly diminished interest or pleasure in everyday activities.  It is estimated by the World Health Organization that MDD affects over 300 million people worldwide (1). Also, Statistics Canada reported in 2013 that approximately 1.3 million Canadians aged 15 years and older met the criteria for depression in the previous year (2). MDD is the leading cause of disability worldwide and is a major contributor to the overall global burden of disease (1).

About REXULTI®
REXULTI® (brexpiprazole) was discovered by Otsuka and co-developed by Otsuka and Lundbeck. It is co-marketed by the two companies. REXULTI® was approved by Health Canada for the treatment of schizophrenia in adults in February 2017. REXULTI® is given in a once-daily oral dose that can be taken with or without food. Elderly patients with dementia treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo.  REXULTI® is not approved for the treatment of patients with dementia.  REXULTI® is not indicated in pediatric patients and its use is not recommended in this population.

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