The FDA has approved Viibryd (vilazodone HCl tablets, from Clinical Data) for the treatment of major depressive disorder (MDD). Viibryd is a selective serotonin reuptake inhibitor and 5HT1A receptor partial agonist. This approval was based on two 8-week, multicenter, randomized, double-blind, placebo-controlled studies in adults who met the criteria for MDD. In these studies, patients were titrated over two weeks to a dose of 40mg of Viibryd once daily. Viibryd was superior to placebo in the improvement of depressive symptoms as measured by the mean change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.

Viibryd is expected to be available in the second quarter of 2011 in 10mg, 20mg, and 40mg dosage strength tablets.

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