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Phase 3 Clinical Trial Initiated for Twice-Daily Formulation of Tramadol-Acetaminophen
"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 of Labopharm's twice-daily tramadol-acetaminophen combination product to placebo in the treatment of acute low back pain. The study, which is being conducted at more than 20 centers in the U.S. and Canada, has a treatment period of approximately one week and is expected to include more than 250 patients.
About the Acute Pain Prescription Market
The number of prescriptions written for acute pain products (mild-opioids, tramadol, COX-2 inhibitors, non-steroidal anti-inflammatory drugs and combinations forms of these products) in the U.S. alone in 2007 grew to 290 million and accounted for sales of US$9.0 billion.
About Tramadol-Acetaminophen Combination Products
Tramadol-acetaminophen combination products offer the analgesic strength of tramadol and the rapid analgesia of acetaminophen in a single tablet. 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 US and the symptomatic treatment of moderate to severe pain in the rest of the world. Tramadol-acetaminophen combination products are currently available only in formulations that must be administered four- to six-times per day.