Forest Laboratories reports positive results from three Phase III trials of vilazodone for GAD treatment

Jun 24 2014

Forest Laboratories, Inc. (NYSE:FRX) today announced positive topline results from three Phase III trials evaluating the efficacy, safety and tolerability of vilazodone in adult patients with generalized anxiety disorder (GAD). In two flexible-dose and one fixed-dose GAD trials, patients who received vilazodone demonstrated statistically significant improvement from baseline in the Hamilton Rating Scale for Anxiety (HAM-A) total score versus placebo at week 8, the primary endpoint.

"Forest is committed to helping people living with generalized anxiety disorder and other mental health conditions. We have a growing mental health portfolio and are one step closer to one day offering general anxiety patients a new treatment option to help manage this condition," said Marco Taglietti, M.D., Chief Medical Officer and EVP, Drug Development and Research at Forest Laboratories, Inc.

Based on these results, the Viibryd supplemental New Drug Application (sNDA) for the treatment of GAD will be filed with the FDA in 2015.