NEW YORK & CASTRES, France--(BUSINESS WIRE)-- Forest Laboratories, Inc. (NYSE: FRX - News) and Pierre Fabre Medicament todayannounced positive top-line results in a Phase III clinical trial of levomilnacipran, an investigational agent for the treatment of adults with major depressive disorder (MDD). Treatment with levomilnacipran significantly reduced depression symptoms in patients with MDD compared to placebo, as early as week one and at each subsequent visit as measured by the Montgomery-Asberg Depression Rating Scale-Clinician Rated (MADRS-CR). This is the second, positive placebo-controlled Phase III study in this population. Further analyses of the data are ongoing. Results from an additional placebo-controlled Phase III fixed-dose study are expected in Spring 2012.
“We have successfully completed two positive Phase III studies for the treatment of MDD in adults and plan to file a new drug application for levomilnacipran with the FDA later this year,” said Dr. Marco Taglietti, Senior Vice President, Research & Development and President, Forest Research Institute.
"We are very pleased with these Phase III positive results. They confirm our strategy to make neuropsychiatry a major priority for our research and development in prescription drugs," said Frédéric Duchesne, President Pharmaceutical Division, Pierre Fabre Group.
About this Phase III Study
This was a randomized, double-blind, placebo-controlled, flexible-dose study evaluating the efficacy, safety and tolerability of levomilnacipran in adult patients with MDD. Following a 1-week single-blind placebo run-in period, 442 men and women, 18-80 years of age, were randomized to receive levomilnacipran 40-120 mg once daily or placebo for 8 weeks. This was followed by an additional 2-week double-blind down-taper period. All patients participating in the study met the criteria for MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), and had a minimum score of 30 on the MADRS-CR. The average baseline score among participating patients was 35 on the MADRS-CR.
The placebo corrected mean change from baseline to end of week 8 in the primary efficacy parameter MADRS-CR total score using the Mixed-Effects Model Repeated Measure (MMRM) analysis was: -3.1 (p= 0.005). Statistically significant improvement was also seen in the Sheehan Disability scale (SDS), the pre-specified key secondary parameter (placebo corrected difference: -2.6, p= 0.001).
Levomilnacipran was generally well-tolerated in this study. Overall, 77 percent of patients completed the study. The premature discontinuation rates (all causes, including adverse-event related) were 25 percent for levomilnacipran and 21 percent for placebo. The most common adverse events (=10% and twice the rate of placebo) observed in the levomilnacipran group were nausea, dizziness, and constipation.
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 has greater potency for norepinephrine reuptake inhibition than for serotonin reuptake inhibition in vitro without directly affecting the uptake of dopamine or other neurotransmitters. Levomilnacipran is a sustained-release formulation, dosed once-daily.
This positive Phase III study of levomilnacipran is part of an ongoing development program which already includes a positive Phase III study that demonstrated statistically significant improvement over placebo. In another Phase III study, levomilnacipran consistently demonstrated improvement relative to placebo over the course of the trial, however the overall difference observed between the drug-treated and placebo-treated patients was not statistically significant. Results from an additional placebo-control Phase III study are expected in Spring 2012.
MDD is a serious medical condition requiring treatment, affecting more than 15 million adults in the United States yearly or approximately 7.3% of the adult U.S. population. People diagnosed with MDD may have a combination of symptoms that can interfere with their ability to work, sleep, study, eat, or enjoy once-pleasurable activities. Depression costs the U.S. an estimated $44 billion each year. Among all medical illnesses, MDD is a leading cause of disability in the U.S. The World Health Organization predicts depression will become the second leading cause of disability in 2012.
About Pierre Fabre Medicament
The Pierre Fabre Laboratories, the second largest independent pharmaceutical group in France, achieved a forecast turnover of 1.9 billion Euros in 2011, with international sales accounting for more than 50%. Their activities cover all aspects of healthcare, from ethical medicines and over-the-counter drugs (OTC) to dermo-cosmetics. The Pierre Fabre Laboratories have some 10,000 employees, 1,300 of whom are dedicated to R&D. In 2011, the company allocated 20% of its drug sales to R&D, focusing on four main areas: oncology, dermatology, women’s health and neuro-psychiatry. With brands including Avène, A-Derma, Ducray, Elgydium, Eludril, Klorane or Pierre Fabre Dermatology, the Pierre Fabre Laboratories are France’s market leader when it comes to cosmetics, hair care, oral products and dermatological products sold in pharmacies. Avène is the leading dermo-cosmetics brand sold in France, and one of the biggest in Europe.
Levomilnacipran was discovered by Pierre Fabre and is licensed to Forest Laboratories Inc., for the US and Canada. Pierre-Fabre will also be the active pharmaceutical ingredient (API) supplier.
To find out more, go to 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, 212-224-6714
Vice President - Investor Relations