Labopharm's once-daily Ryzolt cleared by FDA

Canada's Labopharm says that Ryzolt (tramadol HCl extended-release tablets), its once-daily formulation of the analgesic tramadol, has been  approved by the US Food and Drug Administration. The agent is indicated  for the management of moderate-to-moderately-severe chronic pain in  adults who require around-the-clock relief for an extended period of  time.

"The approval of our first product in the United States is a major  milestone for our company and we look forward to our product's launch  in the world's largest market for pain medications," said James  Howard-Tripp, chief executive. "We believe that Ryzolt offers  physicians and patients an excellent option for the treatment of pain  with the benefit of once-daily dosing. We look forward to the launch of  our product by our marketing partner for the USA, Purdue Pharma," he  added.

Ryzolt is a centrally-acting analgesic composed of a dual-matrix  delivery system with both immediate-release and extended-release  characteristics. Purdue Pharma anticipates launching the drug in 100mg,  200mg and 300mg dosage strengths in the second quarter of 2009. This is  the first US FDA approval that Labopharm has obtained for a medication  using its patented Contramid controlled-release technology for oral  administration of solid dosage compounds. The firm believes this  technology can be applied to a wide range of complex, small, highly  water-soluble molecules to control their release over a 24-hour period  with a desired pharmacokinetic profile.