Labopharm Announces FDA Approval of Once-Daily RYZOLT(TM) (Tramadol HCL Extended Release Tablets) for Management of Moderate to Moderately Severe Ch...(litating condition that affects an estim...),Health

Date:12/31/2008

litating condition that affects an estimated 75 million Americans - more than diabetes, heart disease and cancer combined. The United States is the world's largest market for tramadol products with sales for the 12-month period ended September 2008 of more than US$650 million resulting from more than 25 million prescriptions, which have grown at a compounded annual rate of 11% over the last five corresponding periods. Labopharm believes, however, that RYZOLT will compete not only with other tramadol products, but also with other medications 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.

"In a society where people with pain are increasingly demanding simplified dosing regimens, this once-daily formulation of tramadol should be embraced by physicians and patients alike," said Nicholas J. Messina III, MD, with Vista Medical Research Inc., Mesa, AZ, who was a principal investigator in the U.S. clinical studies on RYZOLT.

Labopharm will host a conference call on Tuesday, January 6, 2009 to discuss this announcement. Additional details for the conference call will be provided via separate news release shortly.

    About the Global Commercialization Program for Labopharm's Once-Daily
    Tramadol Product

Labopharm's once-daily tramadol product is being commercialized globally and to date has been launched in 14 countries, including Canada and the five largest individual markets in Europe. In addition, it has received regulatory approval or is under regulatory review in 29 countries and the Company has established marketing partnerships for its product in 38 countries. Labopharm is continuing to pursue regulatory approval and marketing partnerships for its once-daily tramadol product for other markets around the world in support of its global commercialization program.

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SOURCE Labopharm Inc. Copyright©2008 PR Newswire. All rights reserved

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