Labopharm Reports Positive Results for Phase III Study on Once-daily...( - Study Achieves Primary Efficacy...),Health

- Study Achieves Primary Efficacy Endpoint and Demonstrates Improved

Quality of Sleep -

LAVAL, QC, Feb. 8 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that its recently completed North American Phase III clinical trial for its once-daily formulation of the antidepressant trazodone (study 04ACL3-001) achieved statistical significance for the primary efficacy endpoint (p value of 0.0183). The study also demonstrated significantly improved patient sleep patterns in favour of trazodone. Labopharm plans to file a New Drug Application (NDA) for its once-daily formulation of trazodone with the U.S. Food and Drug Administration later this year.

"The positive results of this study not only demonstrate the efficacy and safety of our once-daily formulation, but also the ability of our formulation to significantly improve the overall quality of sleep - there was significantly less awakening at night," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "It is recognized that a major challenge in treating depression is having patients comply with taking their medication due to slow onset of action and exacerbation of sleep disturbance and agitation. As a result, a once-daily depression treatment that also reduces agitation and improves quality of sleep, thus reducing the need for add-on therapies, should be well positioned in the antidepressant marketplace. We believe that our once-daily trazodone formulation is such a treatment."

Results of the Study

Study 04ACL3-001 is a randomized, double-blind, two-arm, multi-centre study comparing the efficacy and safety of Labopharm's once-daily trazodone formulation to placebo, in patients with major unipolar depressive disorder, over an eight-week period. In the study, 412 patients were randomized to treatment with Labopharm's once-daily trazodone, or placebo. Within the initial two-week titration period, pa
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