Health Canada approves Labopharm's OLEPTRO for treatment of Major Depressive Disorder

Jan 21 2011

- Company Advancing Partnership Discussions and Preparing for Canadian Launch -

Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that Health Canada's Therapeutic Products Directorate (TPD) has approved OLEPTRO(TM) (trazodone hydrochloride Extended Release Tablets), a novel once-daily formulation of the antidepressant trazodone, for the symptomatic relief of Major Depressive Disorder (MDD) in adults. OLEPTRO(TM) acts as a serotonin antagonist reuptake inhibitor (SARI), providing physicians and patients in Canada with a new option in the treatment of MDD.

"We are pleased to announce the approval of OLEPTRO(TM) in Canada - the second approval for this drug in 12 months," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "Our plan is to commercialize OLEPTRO(TM) in Canada with a marketing partner and we are advancing discussions towards this end, while at the same time preparing for the launch of our product."

MDD is a common mental illness often characterized by a combination of emotional, somatic and behavioral symptoms. Approximately 1.6 million Canadians suffer from depression in a given year and more than one in ten Canadians over the age of 15 will suffer from depression during their lifetime. The incidence is highest among women and in younger age groups, and the strongest risk factor is having a family history of major depression. Depression is one of the leading causes of disability globally. Sales of antidepressants in Canada in 2009 totalled almost $1 billion.

Nearly 28 percent of patients being treated with antidepressants stop taking their medication within the first four weeks of treatment and as many as 44 percent stop within the first 12 weeks, due to reasons such as lack of efficacy, exacerbation of symptoms, including sleep disturbance and agitation, and/or adverse events such as weight gain or sexual dysfunction.

"OLEPTRO(TM) offers Canadian physicians a therapeutic alternative for treating their patients with major depressive disorder, one that combines the mechanism of action of a serotonin antagonist reuptake inhibitor, or SARI, with a novel once-daily dosing option," said Dr. Jeffrey Dayno, Chief Medical Officer, Labopharm Inc. "This is important because we know that patients with MDD present with unique symptom profiles and respond differently to treatment. Physicians appreciate options to better individualize patient care."

OLEPTRO(TM) utilizes CONTRAMID(R), Labopharm's clinically validated technology that controls the release of active substances within oral medications.

"An important factor often arising in the clinical management of depression is the need to switch antidepressants or to prescribe additional medications to address antidepressant-induced side effects such as sexual dysfunctions and poor quality of sleep," commented Dr Pierre Blier, Director of Mood Disorders Research at the University of Ottawa Institute of Mental Health Research. "With OLEPTRO(TM), Labopharm has developed a new formulation of trazodone that effectively treats patients with depression and provides a tolerable side effect profile. In fact, OLEPTRO(TM) was shown to be statistically superior to placebo in the Phase III placebo-controlled clinical study in Major Depressive Disorder and was associated with an improvement in the quality of sleep. The incidence of agitation, weight gain, and sexual dysfunction was no different from placebo."