Forest Laboratories, Inc. Announces Positive Topline Results from Three Phase III Trials for Vilazodone in the Treatment of Generalized Anxiety Disorder (GAD)

NEW YORK--(BUSINESS WIRE)--

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.

About the fixed-dose Phase III Study (MD-05)

This multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-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 680 patients between 18 and 70 years of age were randomized to one of three treatment groups (either vilazodone 20 or 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 40 mg/day group relative to the placebo group (Least squares mean difference (LSMD): vilazodone 20 mg/day: -1.3, p=0.0830; vilazodone 40 mg/day: -1.8, p=0.0312) using a mixed-effect model for repeated measures (MMRM). For both vilazodone dose groups the most common adverse events (incidence ≥10% and greater than placebo) were nausea, diarrhea, and headache.

About Vilazodone

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

Visit VIIBRYD.com for more information.

About Generalized Anxiety Disorder

Anxiety disorders are the most common mental illness in the U.S., affecting 40 million adults in the United States age 18 and older (18% of U.S. population), and cost the U.S. more than $42 billion a year. The prevalence of generalized anxiety disorder (GAD) is estimated to be 6.8 million adults or 3.1% of the U.S. population, and it affects women twice as often as men. According to The Diagnostic and Statistical Manual of Mental Disorders (DSM-V), the essential features of GAD are excessive anxiety and worry (apprehensive expectation) about everyday events or activities for a period of six months or more. Anxiety and worry can also be associated with physical symptoms that cause significant distress and affect daily functioning. For a diagnosis to be made, worry must be present more days than not for at least six months. GAD frequently co-occurs with mood disorders, including depression. Additionally, up to 80% of people suffering from depression also experience symptoms of anxiety. Anxiety disorders are highly treatable, yet only about one-third of those suffering receive treatment.

About Forest Laboratories, Inc.

Forest Laboratories FRX is a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market. Forest markets a portfolio of branded drug products and develops new medicines to treat patients suffering from diseases principally in five therapeutic areas: central nervous system, cardiovascular, gastrointestinal, respiratory, and anti-infective. Forest's strategy of acquiring product rights for development and commercialization through licensing, collaborative partnerships and targeted mergers and acquisitions allows Forest to take advantage of attractive late-stage development and commercial opportunities, thereby managing the risks inherent in drug development. In January 2014, Forest acquired Aptalis Pharmaceuticals for $2.9 billion in cash in order to gain access to its GI and Cystic Fibrosis products, including treatments for Ulcerative Proctitis, Duodenal Ulcers, H. Pylori, Anal Fissures, and Pancreatic Insufficiency. In February 2014, Forest and Actavis plc announced an agreement where Forest would be acquired for about $25 billion in cash and stock. The acquisition of Forest by Actavis is contingent upon regulatory and shareholder approvals.

Forest is headquartered in New York, NY.

Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings. Forest assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments.