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Labopharm reports results for Phase III study on twice-daily tramadol-acetaminophen formulation
Date:4/2/2009

y in clinical trials. Labopharm believes that it is likely that the results of this trial are insufficient to support the acceptance of a New Drug Application (NDA) by the Food and Drug Administration (FDA) in the United States. The Company intends to discuss the matter with the FDA's Division of Anesthesia, Analgesia & Rheumatology Products (DAARP) to determine the path forward. The results of this study are however statistically significant under analyses that the Company believes may be accepted for the evaluation of analgesics in Europe, Canada and other jurisdictions. Accordingly, the Company intends to meet with the regulatory authorities for these jurisdictions at the earliest available opportunity in pursuit of regulatory approval. Should the authorities be in agreement, the Company expects that it would submit a regulatory application in those jurisdictions.

The Company will provide additional information following discussions with the various regulatory authorities.

The results of the study have no bearing on the upcoming launch of the Company's once-daily tramadol product in the United States.

About Tramadol-Acetaminophen Combination Products

Tramadol-acetaminophen products leverage the unique but complementary modes of action of each of the active ingredients to provide the analgesic strength of a mild opioid (tramadol) and the rapid pain relief of acetaminophen. Tramadol-acetaminophen combination products were first launched in 2001 in the United States and in 2003 in other major markets and are indicated for the short-term (five days or less) management of acute pain in the U.S. and the symptomatic treatment of moderate to severe pain in the rest of the world.

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 o
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SOURCE Labopharm Inc.
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