Labopharm, a Canadian specialty pharmaceutical company, has announced that the FDA has approved Ryzolt, the company's once-daily formulation of the analgesic tramadol.
Ryzolt is 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.
Labopharm said that the approval of Ryzolt is the first FDA approval that the company has obtained for a medication using its patented Contramid controlled-release technology for oral administration of solid dosage medications. Labopharm believes that its Contramid 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.
Ryzolt is a centrally acting analgesic composed of a dual-matrix delivery system with both immediate-release and extended-release characteristics.
Labopharm's marketing partner for its product in the US, Purdue Pharma, anticipates launching Ryzolt tablets in 100mg, 200mg and 300mg dosage strengths in the second quarter of 2009.
James Howard-Tripp, president and CEO of Labopharm, said: "The approval of our first product in the US 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. 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 US, Purdue Pharma."