Healthcare Industry News:  Purdue Pharma 

Biopharmaceuticals FDA

 News Release - January 30, 2006

Labopharm's Once-Daily Tramadol NDA Accepted for Review by U.S. FDA

LAVAL, QC, Jan. 30 (HSMN NewsFeed) - Labopharm Inc. (TSX:DDS ) today announced that its New Drug Application (NDA) for once-daily tramadol has been accepted for review and filed by the U.S. Food and Drug Administration (FDA).

Labopharm submitted the NDA for its once-daily formulation of the analgesic tramadol for the management of moderate to moderately severe pain on November 28, 2005. The action date under the Prescription Drug User Fee Act (PDUFA) is September 28, 2006.

"The acceptance of our first NDA is an important milestone for our Company," said James Howard-Tripp, President and CEO of Labopharm Inc. "We look forward to the FDA's review and are excited about the prospects of commercializing our product in the U.S."

About Labopharm Inc.

Labopharm Inc. (TSX: DDS ) 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 in-house 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 Products L.P., the premier marketer of long-acting pain medications in that country. The Company's pipeline includes a combination of in-house and partnered programs with products both in clinical trials and in preclinical development. For more information, please visit

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

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