Forest Laboratories, Inc. and Pierre Fabre Announce Topline Phase III Results from a Study of Levomilnacipran for the Treatment of Major Depressive Disorder; Drug Fails to Meet Statistical Significance
Levomilnacipran was well tolerated in this study. Overall, 80% of patients completed the study. Eight percent (8.0%) of patients prematurely discontinued the study due to adverse events in the levomilnacipran group compared to 2.2% in the placebo group. The most common adverse events in the levomilnacipran group were nausea and headache.
This Phase III study is part of the ongoing development program for levomilnacipran. Two additional placebo-controlled Phase III studies of levomilnacipran in patients with MDD are currently underway. Results from these studies are expected to be available in the second half of this calendar year.
These top-line results differ from previous findings in a 563 patient Phase II study of levomilnacipran, which demonstrated statistically significant improvement compared to placebo (p<0.0001) on the primary endpoint, change from baseline in total score on the MADRS.
About the Phase III Study
This was a randomized, double-blind, placebo-controlled, flexible-dose study in patients with MDD. Patients 18 to 80 years of age, who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD and a minimum score of 30 on the MADRS-CR were eligible for enrollment in this study.
Following a 1-week single-blind placebo run-in period, a total of 362 patients were randomized to receive levomilnacipran 40-120 mg once daily or placebo for 8-weeks followed by an additional 2-week double-blind down-taper period.
The protocol specified primary endpoint was change from baseline to end of week 8 in MADRS-CR total score for levomilnacipran 40-120 mg/d relative to placebo using the MMRM analyses.
About the Phase II Study
This randomized, double-blind, placebo-controlled study assessed levomilnacipran 75-100 mg/d in patients with MDD for 10 weeks. 563 patients aged 18 to 70 in Europe who met DSM-IV-TR criteria for MDD with a current major depressive episode and a minimum total score of 22 on the HAMD-17 were randomized to receive levomilnacipran, administered once daily, or placebo.
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 affects approximately 18 million adults in the U.S. One of every 4 women and 1 in 10 men can expect to be diagnosed with depression during their lifetime. 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 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 Frank.Murdolo@frx.com