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Labopharm Submits Complete Response to FDA as a Result of Outcome of Appeal Process for Once-Daily Tramadol
Date:7/2/2008

LAVAL, QC, July 2 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has submitted a complete response to the Food and Drug Administration (FDA) per the suggestion of Dr. Douglas Throckmorton, M.D., the FDA's Deputy Director, Center for Drug Evaluation and Research (CDER), as the next step in the regulatory path towards potential U.S. approval of the Company's once-daily formulation of tramadol. The complete response centers on the additional analysis of existing data using the methodology put forward by Dr. John K. Jenkins, M.D., Director for the Office of New Drugs, CDER, in his letter earlier this year.

Upon acceptance for review of the response, the FDA will assign an action date under the Prescription Drug User Fee Act (PDUFA).

About Labopharm's Once-Daily Tramadol Product

Labopharm's once-daily tramadol product is based on the Company's proprietary Contramid(R) technology, which provides a dual matrix delivery system allowing both rapid and sustained drug release that maintains blood levels within the therapeutic range providing a full 24 hours of pain relief. The Company believes that maintaining drug concentrations within the therapeutic range has the advantage of fewer and less severe side effects while maintaining efficacy. Under its global commercialization program, Labopharm's once-daily tramadol product has been launched in 12 countries, including the five largest markets in Europe and Canada and is approved in 19 other countries. Including those countries in which its product has been launched, Labopharm has licensing and distribution agreements in place for more than 50 markets globally.

About Labopharm Inc.

Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets
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SOURCE Labopharm Inc.
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