Labopharm Initiates Phase III Clinical Trial for Twice-Daily Formulation of Tramadol-Ace...( - Formulation Has Potential to Addre...),Health

- Formulation Has Potential to Address Large Acute Pain Prescription Drug

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LAVAL, QC, March 10 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has begun enrolling patients in its Phase III clinical trial for its twice-daily, tramadol-acetaminophen combination product (study 06CCL3-001).

"Tramadol-acetaminophen combination products have become widely prescribed based on their ability to provide the analgesic potency of tramadol and the rapid efficacy of acetaminophen, as well as their use in treating a broad spectrum of pain types," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "Our formulation has the potential to be the first twice-daily tramadol-acetaminophen product, as well as to compete in the broader acute pain prescription drug market globally. Accordingly, it would be an excellent complement to our once-daily tramadol product for the treatment of persistent pain."

Currently marketed tramadol-acetaminophen combination products must be administered four- to six-times per day. Labopharm believes that by metering the release of both tramadol and acetaminophen from a single tablet using its Contramid(R) controlled-release technology, its formulation has the potential to offer enhanced patient compliance through twice-daily administration, as well as a potentially improved side effect profile. More importantly, based on its potential potency, efficacy, safety and convenience, the Company's novel formulation of tramadol-acetaminophen could be well positioned as an alternative to other prescription products for the treatment of mild to moderate acute pain, including mild-opioids, tramadol, COX-2 inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs) and combination forms of these products.

Study 06CCL3-001 is a multi-centre, randomized, double-blind, parallel-arm study that will compare the efficacy and safety o
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