The FDA has approved Oleptro (trazodone HCl extended-release tablets, from Labopharm), a once-daily formulation of trazodone, for the treatment of major depressive disorder (MDD) in adults. Oleptro utilizes the proprietary Contramid technology, which controls the release of active substances within oral medications. This approval was based on an eight-week, multicenter, randomized, double-blind, two-arm study in patients with unipolar MDD. The primary endpoint, the change in the Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to the end of study in the Oleptro group versus the placebo group, was achieved (p=0.012).
Oleptro is expected to be available later in 2010.
For more information call (450) 686-1017 or visit www.labopharm.com.