Labopharm´s NDA for its antidepressant formulation containing trazodone is based on data from five pivotal pharmacokinetic studies and the positive results from its U.S. Phase III placebo controlled clinical trial (study 04ACL3-001), which enrolled more than 400 patients.

According to Labopharm´s Phase III study, the primary endpoint achieved statistical significance providing an improvement from baseline to the end. Patients experienced rapid onset of action as demonstrated by a clinically significant improvement within the first two weeks of treatment.

In addition, the study demonstrated an improvement in the overall quality of sleep and a favorable adverse event profile, including transient mild to moderate somnolence, no difference from placebo in anxiety, agitation, sexual dysfunction and weight change.

Major depression is one of the most prevalent central nervous disorders, affecting more than 120 million people worldwide. In 2007, $ 19 billion dollars worth of anti-depressants were prescribed globally, with more than $ 12 billion dollars spent in the U.S. alone.

According to the World Health Organization, 40 percent of patients treated with current medications may discontinue treatment within the first 12 weeks due to limitations with existing products and their unwanted side effects.

Current competitors on the market for Labopharm´s DDS-04A are Wyeth´s recently launched Pristiq (a serotonin-norepinephrine reuptake inhibitor (SNRI), a follow-up of its blockbuster Effexor ER (venlafaxine), which although already off-patent, had sales of over $ 2.04 billion dollars in the first half of this year, competing with generics; and Eli Lilly´s Cymbalta (duloxetine), with sales of $ 1.26 billion dollars in the same period.