FDA Approves RYZOLT For Chronic Pain Treatment
Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that RYZOLT (tramadol HCl extended release tablets), Labopharm's once-daily formulation of the analgesic tramadol, has been approved by the U.S. Food and Drug Administration (FDA). 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.
"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 R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "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 U.S., Purdue Pharma."
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 United States, Purdue Pharma L.P., anticipates launching RYZOLT tablets in 100 mg, 200 mg and 300 mg dosage strengths in the second quarter of 2009.
The approval of RYZOLT is the first U.S. FDA approval that Labopharm 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.
Pain is a potentially debilitating condition that affects an estimated 75 million Americans - more than diabetes, heart disease and cancer combined. The United States is the world's largest market for tramadol products with sales for the 12-month period ended September 2008 of more than US$650 million resulting from more than 25 million prescriptions, which have grown at a compounded annual rate of 11% over the last five corresponding periods. Labopharm believes, however, that RYZOLT will compete not only with other tramadol products, but also with other medications 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.
"In a society where people with pain are increasingly demanding simplified dosing regimens, this once-daily formulation of tramadol should be embraced by physicians and patients alike," said Nicholas J. Messina III, MD, with Vista Medical Research Inc., Mesa, AZ, who was a principal investigator in the U.S. clinical studies on RYZOLT.