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product-approval , Product Safety


Abilify® (aripiprazole) has received an additional approval from Health Canada as an adjunct, or add-on, treatment to antidepressants for the treatment of major depressive disorder (MDD) in adults who had an inadequate response to prior antidepressant treatments during the current episode. When used with an antidepressant, Abilify has been shown to improve the symptoms of adults living with MDD who had an inadequate response to at least two trials with antidepressants during the current episode. It is the first add-on treatment for MDD to be approved in Canada. 

The Health Canada approval is based on results from three six-week double-blind, randomized, placebo-controlled, multicentre studies (n=1088). The results from all three studies demonstrated significant improvement in depressive symptoms in adult patients with a primary diagnosis of MDD who had experienced an inadequate response[1] to monotherapy with two or more antidepressants. In fact, significant improvements in depression symptoms were seen in the second week of add-on treatment with Abilify, when compared to the control.

“Even if a patient responds according to set standardized scores, they often still experience problematic residual symptoms, which can prevent a fully functional return to everyday activities.  Furthermore, these residual symptoms are a strong predictor of relapse within a relatively short timeframe,” says Dr. Pierre Blier, Head of the Mood Disorders Research Unit of the Royal Ottawa Hospital and Government of Canada Chair in Psychopharmacology. “In the Canadian CANMAT treatment guidelines for the treatment of MDD – as in others around the world – Abilify is recommended for add-on to antidepressants. This new indication gives physicians and their patients with MDD an option when relief cannot be achieved with antidepressants alone.”

MDD is a serious mental illnesscharacterized by one or more major depressive episodes. The primary symptom of MDD is a sad, despairing mood, which is present most days and lasts most of the day, continues for more than two weeks, and impairs the individual’s functioning at work, at school and / or in social relationships. MDD is a complex mood disorder, which is caused by several factors including genetic disposition, personality, stress, and brain chemistry. It can develop at any age, with the average age of onset in the mid-twenties. 

 “Major Depression Disorder is a tremendous burden, to the individual living with the illness, their family and friends and ultimately the Canadian economy. By having new options to relieve and control symptoms, the physicians treating these individuals are better equipped tohelp them function in their daily lives – be it performing at school, being more productive at work or interacting in social situations,” says Phil Upshall, National Executive Director of Mood Disorders Society of Canada.

About Major Depressive Disorder in Canada

Depression is a significant contributor to global disease burden and constitutes the single leading cause of disability worldwide according to the World Health Organization. Depression is the most common illness among those who die from suicide, with approximately 60 per cent suffering from this condition.

In Canada, MDD affects eight per cent of the population, or approximately 2.64 million Canadians in a given year. While some may experience only a single episode within their lifetime, more often a person has multiple episodes. If left untreated, the frequency of MDD and severity of its symptoms increase over time and can lead to suicide. In adults, MDD occurs in women twice as frequently as men. 

Depression can start at a young age and is often recurring. It profoundly affects everyday function and carries a heavy personal, social, and financial burden on health care resources. Patients who do not respond to treatment with antidepressants alone suffer from a difficult-to-treat, long-standing episode of depression; they are estimated to constitute 28.8 per cent of adult patients with depression.

MDD and other mental illnesses result in a significant cost on the Canadian economy. At least 500,000 employed Canadians are unable to work due to mental illness every week, including approximately 355,000 disability cases due to mental and / or behavioural disorders and approximately 175,000 full-time employees are absent from work due to mental health issues. The estimatedcost of mental illness in Canada due to health care costs and loss of productivity is $51 billion.  

About Abilify®

Abilify®, is the first therapy approved by Health Canada for add-on treatment of major depressive disorder in adults and also the first Health Canada approved antipsychotic for adolescents (schizophrenia patients 15-17 years old and acute treatment of manic or mixed episodes in bipolar I disorder as monotherapy in adolescent patients 13-17 years of age). It was first approved on July 9, 2009 by Health Canada for the treatment of schizophrenia and related psychotic disorders in adults and for the treatment of manic or mixed episodes in bipolar I disorder in adults as acute monotherapy or co-therapy with lithium or divalproex sodium when there is an insufficient acute response to these agents alone. 

About Bristol-Myers Squibb Canada

Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Bristol-Myers Squibb Canada is a leading provider of medicines to fight cancer, cardiovascular and metabolic disorders, infectious diseases (including HIV/AIDS), nervous system diseases and serious mental illness. Bristol-Myers Squibb Canada's operations are headquartered in Montréal, Québec.

About Otsuka Canada Pharmaceutical Inc.

Otsuka Canada Pharmaceutical Inc. (OCPI) is an innovative, fast-growing health care company that commercializes Otsuka medicines in Canada, with a focus on and commitment to neuroscience, cardiovascular, and oncology treatments. OCPI is dedicated to improving patients' health and the quality of human life. OCPI is part of the Otsuka Group, and was established in 2010, with headquarters in Technoparc Montréal, in Saint-Laurent, Québec.