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Labopharm Announces FDA Approval of Once-Daily RYZOLT(TM) (Tramadol HCL Extended Release Tablets) for Management of Moderate to Moderately Severe Chronic Pain
Date:12/31/2008

Product to be Launched in the U.S. in the Second Quarter of 2009

LAVAL, QC, Dec. 31 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that RYZOLT(TM) (tramadol HCl extended release tablets), Labopharm's once-daily formulation of the analgesic tramadol, has been approved by the U.S. Food and Drug Administration (FDA). RYZOLT is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

"The approval of our first product in the United States is a major milestone for our Company and we look forward to our product's launch in the world's largest market for pain medications," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We believe that RYZOLT offers physicians and patients an excellent option for the treatment of pain with the benefit of once-daily dosing. We look forward to the launch of our product by our marketing partner for the U.S., Purdue Pharma."

RYZOLT is a centrally acting analgesic composed of a dual-matrix delivery system with both immediate-release and extended-release characteristics. Labopharm's marketing partner for its product in the United States, Purdue Pharma L.P., anticipates launching RYZOLT tablets in 100 mg, 200 mg and 300 mg dosage strengths in the second quarter of 2009.

The approval of RYZOLT is the first U.S. FDA approval that Labopharm has obtained for a medication using its patented Contramid(R) controlled-release technology for oral administration of solid dosage medications. Labopharm believes that its Contramid technology can be applied to a wide range of complex, small, highly water soluble molecules to control their release over a 24-hour period with a desired pharmacokinetic profile.

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SOURCE Labopharm Inc.
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