"We are extremely pleased with these results. This data enhances our NDA currently being reviewed by the FDA," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc.
The results of the study will be added to the Company's New Drug Application (NDA) for once-daily tramadol in the United States, which is currently under review by the Food and Drug Administration (FDA). Based on discussions with the FDA, the Company plans to submit the data on a timely basis such that the action date under the Prescription Drug User Fee Act (PDUFA) remains September 28, 2006.
Results of the Study
The randomized, double-blind, multi-centre 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 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. Patients were randomized to treatment with Labopharm's once-daily tramadol or placebo and underwent double-blind titration to an optimal dose of either 200 or 300 mg. The optimal dose for each patient, which was maintained for a period of 12-weeks, was selected based on the effectiveness of pain relief and the tolerability of adverse events. Approximately 1,000 patients were enrolled in this trial.
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 (PI-NRS) in the once-daily tramadol group versus the placebo group. Statistical significance was achieved for the primary endpoint (p value of 0.0157) and was maintained under additional methods of analysis. The drop-out rate was comparable to that of the Company's European Phase III trial (MDT3-001). The incidence of adverse events was lower than in study MDT3-001, and similar to the previous two U.S. Phase III clinical trials (MDT3-002 and MDT3-003).
About Labopharm Inc.
Labopharm Inc. (TSX: DDS - News) is an international, specialty pharmaceutical company focused on the development of drugs incorporating Contramid®, the Company's proprietary advanced controlled-release technology. Labopharm's lead product, a once-daily formulation of the analgesic tramadol, is marketed in Germany and has received regulatory approval in 21 other European countries. In the U.S., the Company's NDA for once-daily tramadol is under review at the FDA and the Company has secured a licensing and distribution agreement with Purdue Pharma, a premier marketer of long-acting pain medications. The Company's pipeline includes a combination of proprietary and partnered programs with products both in clinical trials and in preclinical development. For more information, please visit www.labopharm.com.
This press release contains forward-looking statements, which reflect the Corporation's current expectations regarding future events. The forward- looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the successful and timely completion of clinical studies, the uncertainties related to the regulatory process and the commercialization of the drug thereafter. Investors should consult the Corporation's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Corporation disclaims any obligation to update these forward-looking statements.
Source: Labopharm Inc.
