BioCentury
ARTICLE | Clinical News

Forest planning Viibryd sNDA for GAD

June 24, 2014 1:02 AM UTC

Forest Laboratories Inc. (NYSE:FRX) reported data from three Phase III trials of Viibryd vilazodone to treat generalized anxiety disorder (GAD) and said it plans to submit an sNDA to FDA next year. In the MD-06 and MD-07 trials, flexible doses of 20-40 mg/day oral Viibryd met the primary endpoint of improving Hamilton Anxiety Scale (HAM-A) total score from baseline to week eight vs. placebo. In the third MD-05 trial, a 40 mg/day fixed dose of the drug met the primary endpoint while a 20 mg/day fixed dose missed the endpoint vs. placebo. Viibryd is a mixed selective serotonin reuptake inhibitor (SSRI) and partial serotonin (5-HT1A) receptor agonist. It already is approved in the U.S. to treat major depressive disorder (MDD). ...