LABOPHARM'S TRAMADOL MEETS KEY TRIAL ENDPOINT
Labopharm has reported that its version of the once-daily painkiller tramadol had achieved a key primary endpoint in a Phase III trial.
The resultsof the study will be added to its new drug application for Tramadol in the U.S. The application is currently under review by the FDA.
The randomized, double-blind trial, which involved about 1,000 patients, compared the safety and efficacy of Labopharm's once-daily formulation of tramadol to placebo over a 12-week period with the primary endpoint comparing baseline pain intensity with pain intensity at the end of the study period.