Labopharm Reports Results for First Quarter F...(mulation to the next supervisorylevel. L...),Health

Date:5/8/2008

mulation to the next supervisory level. Labopharm's continuation of the appeal process followed the completion of additional statistical analysis of existing data per the Agency's suggestion as a means to potentially satisfy its requirements for regulatory approval. The Company believes that the additional analysis confirms the conclusions of efficacy of its once-daily tramadol formulation as demonstrated in previous analyses that were included in its New Drug Application (NDA) and additional submissions thereafter.

Trazodone Contramid(R) Once-a-Day for Treatment of Depression

Reported Positive Results for Phase III Trial - Labopharm reported positive results for its Phase III clinical trial for once-daily trazodone (study 04ACL3-001). In addition to achieving statistical significance for the primary endpoint (p value of 0.0183) for efficacy in the treatment of depression, the study shows an improvement of the overall quality of sleep. Moreover, the study demonstrated that once-daily trazodone was statistically superior to placebo by the end of the first week of treatment. The Company plans to file a New Drug Application (NDA) for its once-daily formulation with the FDA later this year.

Twice-Daily Tramadol-Acetaminophen Combination Product

Initiated Phase III Clinical Trial - Labopharm began enrolling patients in its North American Phase III clinical trial for its twice-daily, tramadol-acetaminophen combination product (study 06CCL3-001). The Company expects data to be available later this year.

Misuse Prevention Platform

Completed Preclinical Studies on Proof of Principle - Labopharm completed pre-clinical, proof-of-principle studies using once-daily tramadol as a safe representative of the controlled-release opioid class of drugs. The positive results of the pharmacokinetic and in vitro studies demonstrated controlled-release and misuse prevention characteristics, respectively.

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SOURCE Labopharm Inc. Copyright©2008 PR Newswire. All rights reserved

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