The FDA has approved Ryzolt (tramadol HCl extended-release tablets), a once-daily formulation of the analgesic tramadol. Ryzolt is indicated for the management of moderate-to-moderately severe chronic pain in adults who require long-term, around-the-clock pain treatment.
Ryzolt is a centrally acting analgesic composed of a dual-matrix delivery system with both immediate-release and extended-release characteristics. Its maker, Labopharm, anticipates launching Ryzolt tablets in 100 mg, 200 mg, and 300 mg dosage strengths in the second quarter of 2009, and will team with Purdue Pharma to market the product in the United States.
Labopharm's once-daily tramadol product has been launched in 14 countries, including Canada and the five largest individual markets in Europe. In addition, it has received regulatory approval or is under regulatory review in 29 countries.