Forest Labs Reports Positive Topline Results From 3 Ph3 Trials For Vilazodone

(RTTNews) - Forest Laboratories, Inc. (FRX) on Monday announced positive topline results from three Phase III trials evaluating the efficacy, safety and tolerability of vilazodone in adult patients with generalized anxiety disorder.

Vilazodone, also known by its brand name VIIBRYD, is a selective serotonin reuptake inhibitor and 5-HT1A receptor partial agonist approved by the FDA for the treatment of adults with Major Depressive Disorder.

In two flexible-dose and one fixed-dose generalized anxiety disorder trials, patients who received vilazodone showed statistically significant improvement from baseline in the Hamilton Rating Scale for Anxiety total score versus placebo at week 8, the primary endpoint.

Based on the results, the Viibryd supplemental New Drug Application for the treatment of generalized anxiety disorder will be filed with the FDA in 2015, Forest Labs said.