UPDATE: Forest Labs Announces Positive Topline Phase III Results For Vilazodone

Forest Laboratories, Inc. 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. About the flexible-dose Phase III Study (MD-07) This multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose, 8-week Phase III study evaluated the efficacy, safety, and tolerability of vilazodone as treatment in adult patients with GAD. Eligible patients were those who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for GAD, and had a minimum total score of 20 on the HAM-A scale. Following a 7 day screening period, a total of 415 patients between 18 and 70 years of age were randomized to one of two treatment groups (vilazodone 20 - 40 mg/day, or placebo) followed by a 1-week down-taper safety period. The primary endpoint was defined as change from baseline to end of week 8 in the HAM-A total score. Statistically significant improvement in the HAM-A total score was observed in the vilazodone 20 - 40 mg/day group relative to the placebo group (Least squares mean difference (LSMD): vilazodone 20 - 40 mg/day: -2.2, p=0.0048) using a mixed-effect model for repeated measures (MMRM). Most common adverse events in the vilazodone 20-40 mg/day group (incidence >=10 % and greater than placebo) were nausea, diarrhea, headache, and dizziness. About the flexible-dose Phase III Study (MD-06) This multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose, 8-week Phase III study evaluated the efficacy, safety, and tolerability of vilazodone as treatment in adult patients with GAD. Eligible patients were those who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for GAD, and had a minimum total score of 20 on the HAM-A scale. Following a 7 day screening period, a total of 402 patients between 18 and 70 years of age were randomized to one of two treatment groups (vilazodone 20 - 40 mg/day, or placebo) followed by a 1-week down-taper safety period. The primary endpoint was the change from baseline to end of week 8 in the HAM-A total score. Statistically significant improvement in the HAM-A total score was observed in the vilazodone 20 - 40 mg/day group relative to the placebo group (Least squares mean difference (LSMD): vilazodone 20 - 40 mg/day: -1.50, p=0.0438;) using a mixed-effect model for repeated measures (MMRM). Most common adverse events in the vilazodone 20-40 mg/day group (incidence >=10 % and greater than placebo) were nausea, and diarrhea.