Labopharm says tramadol meets primary endpoint in phase 3 trial for osteoarthritis pain

By E. Janene Geiss

Philadelphia, April 12 - Labopharm Inc. announced Wednesday that its recently completed multi-center phase 3 clinical trial for its once-daily formulation of tramadol achieved statistical significance for the primary endpoint.

The data enhances the company's New Drug Application currently being reviewed by the Food and Drug Administration, officials said in a company news release. The results of the study will be added to the company's application for once-daily tramadol.

Based on discussions with the FDA, the company said plans to submit the data on a timely basis so that the action date under the Prescription Drug User Fee Act remains Sept. 28, 2006.

The randomized, double-blind parallel study, conducted under a Special Protocol Assessment with the FDA, compared the safety and efficacy of Labopharm's once-daily formulation of tramadol to a placebo over a 12-week period.

Enrollment in the trial consisted of patients diagnosed with moderate to severe pain associated with osteoarthritis of the knee.

About 1,000 patients were randomized to treatment with Labopharm's once-daily tramadol or a placebo and underwent double-blind titration to an optimal dose of either 200 mg or 300 mg, officials said.

The optimal dose for each patient, maintained for a period of 12 weeks, was selected based on the effectiveness of pain relief and the tolerability of adverse events, officials said.

The primary endpoint of the study was to compare baseline pain intensity with pain intensity at the end of the study period as measured by the 11-point Pain Intensity Numerical Rating Score in the once-daily tramadol group versus the placebo group.

Statistical significance was achieved for the primary endpoint and was maintained under additional methods of analysis. The drop-out rate was comparable to that of the company's European phase 3 trial, officials said.

Labopharm is a Laval, Quebec, specialty pharmaceutical company focused on the development of drugs incorporating Contramid, the company's proprietary advanced controlled-release technology.

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