NEW YORK & PARIS--(BUSINESS WIRE)-- Forest Laboratories, Inc. (NYSE:FRX - News) and Pierre Fabre Medicament today announced preliminary top-line results from a Phase III study of levomilnacipran for the treatment of adults with major depressive disorder (MDD). Analyses of the data indicate a statistically significant improvement was achieved for levomilnacipran treated patients for all dose groups compared to placebo on the primary efficacy endpoint which was change from baseline to end of week 8 in the Montgomery-Asberg Depression Rating Scale-Clinician Rated (MADRS-CR) total score. Further analyses of the data are ongoing.
“Depressed patients often struggle to find the right antidepressant and the need for new medications is high. These positive Phase III results are very encouraging and support the continued research of levomilnacipran in adult patients with major depressive disorder,” said Dr. Marco Taglietti, Senior Vice President, Research & Development and President, Forest Research Institute.
This study is part of the ongoing development program for levomilnacipran for the treatment of MDD, which also includes a Phase III flexible-dose study reported in January 2011. Results from two additional placebo-controlled Phase III studies are expected at the end of this year and spring 2012, respectively.
About this Phase III Study
This was a randomized, double-blind, placebo-controlled, fixed-dose study evaluating the efficacy, safety and tolerability of levomilnacipran in patients with MDD. Following a 1-week single-blind, placebo run-in period, 724 men and women, 18 to 65 years of age, who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD and had a minimum score of 30 on the MADRS-CR, were randomized to receive levomilnacipran at 40, 80 or 120 mg once daily, or placebo for 8 weeks. This was followed by an additional 2-week double-blind down-taper period.
The primary analysis was performed using the Mixed-Effects Model Repeated Measure (MMRM) analysis. The placebo corrected difference in mean change from baseline to end of week 8 in MADRS-CR total score was: -3.2 (p=0.019), -4.0 (p=0.004) and -4.9 (p<0.001) in 40, 80, 120 mg groups, respectively.
Levomilnacipran was generally well-tolerated in the study. The most common adverse events (=10% and twice the rate of placebo) observed in the levomilnacipran dose groups were: nausea, constipation, increase in heart rate, and hyperhidrosis.
Levomilnacipran (1S,2R-milnacipran), an enantiomer of racemic milnacipran, is protected by a method of use patent that extends through June 2023, without patent term extension. Levomilnacipran is a potent and selective inhibitor of the reuptake of norepinephrine and serotonin, two neurotransmitters known to play key roles in regulating mood. Levomilnacipran is a sustained-release formulation, dosed once-daily.
MDD is a serious medical condition requiring treatment, affecting more than 15 million adults in the United States yearly or approximately 6.5% of the adult U.S. population. A person diagnosed with MDD exhibits a combination of symptoms that interfere with one's ability to work, sleep, study, eat and enjoy once-pleasurable activities. Depression costs the U.S. an estimated $44 billion each year. The World Health Organization predicts depression will become the leading cause of disability by the year 2020.
About Pierre Fabre Medicament
The Pierre Fabre Group, the second largest independent laboratory in France, employs some 10,000 people, and achieved a turnover of 1.8 billion euros in 2009. The lines of business are ethical medicine, family health but also in dermo-cosmetic products with several brands: Avene, Ducray, A-Derma, Galenic, Klorane and Rene Furterer and dermo-cosmetics. Pierre Fabre Medicament, the pharmaceutical branch of the Pierre Fabre Group, made Research and Development its core business and the key to its future. With 1,400 employees dedicated to R&D, Pierre Fabre Medicament has invested 28% of its annual sales to R&D during 2009, in four major therapeutic areas in terms of public health: oncology (the priority R&D area of Pierre Fabre Medicament, with 50% of all R&D expenses), the central nervous system, dermatology, and cardiovascular/metabolic. To learn more about Pierre Fabre, visit www.pierre-fabre.com.
About Forest Laboratories
Forest Laboratories’ (NYSE:FRX - News) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective and respiratory medicine. The Company’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com.
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 Reports on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
Forest Laboratories, Inc.Frank J. Murdolo, 212-224-6714Vice President - Investor RelationsFrank.Murdolo@frx.com