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.
For more information call (617) 527-9933 or visit www.viibryd.com.