NEW YORK & CASTRES, France--(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE: FRX) and Pierre Fabre Medicament today announced additional positive results from 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 measured by the Montgomery-Asberg Depression Rating Scale - Clinician Rated (MADRS-CR). This is the third, positive Phase III study of levomilnacipran in adults with MDD. Further analyses of the data are ongoing. The companies anticipate filing a new drug application with the FDA in the third quarter of the calendar year 2012.
“Despite available treatment options, many suffering from major depressive disorder continue to struggle to find a treatment that works for them. This third Phase III study further reinforces the potential of levomilnacipran as an effective treatment option for adults with MDD,” said Dr. Marco Taglietti, Senior Vice President, Research & Development and President, Forest Research Institute.
“We are confident that the efficacy and safety data in these three positive phase III studies will support a successful NDA submission for levomilnacipran in MDD in adult patients. We are looking forward to working with our partner, Forest Laboratories, to file the NDA. These results confirm the relevance of our strategic choice to make neuropsychiatry a major focus of Pierre Fabre R&D”, said Frédéric Duchesne, President Pharmaceutical Division, Pierre Fabre Group.
About this Phase III Study
This was a randomized, double-blind, placebo-controlled, fixed-dose study evaluating the efficacy, safety and tolerability of levomilnacipran compared with placebo in adult patients with MDD. Following a 1-week single-blind placebo run-in period, 568 men and women, 18-75 years of age, were randomized to receive either levomilnacipran 40 mg or 80 mg once daily or placebo for eight weeks. This was followed by an additional 1-week double-blind down-taper period. All patients participating in the study met the criteria for recurrent 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 26 on the MADRS-CR. The average baseline score among participating patients was 31 on the MADRS-CR.
The placebo-corrected mean change from baseline to end of week 8 in total MADRS-CR score (primary efficacy parameter) was: -3.3 (p=0.0027) and -3.14 (p=0.0043) in the 40 and 80 mg groups, respectively. The primary efficacy analysis was performed using a pre-specified mixed-effects model for repeated measures (MMRM). Statistically significant improvement was also seen in the Sheehan Disability Scale (SDS), the pre-specified key secondary efficacy parameter (placebo corrected difference: -1.83 (p=0.0459) and -2.72 (p=0.0028) in the 40 and 80 mg groups, respectively).
Levomilnacipran was generally well-tolerated in this study. Overall, 78.5% of patients completed the study. The premature discontinuation rates (all causes, including adverse-event related) were 17.2%, 22.9%, and 24.5% for placebo, levomilnacipran 40 mg and 80 mg groups, respectively. The most common adverse events (≥10% and twice the rate of placebo) observed in the levomilnacipran groups were nausea and dry mouth.
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 an SNRI and 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 given as a sustained-release formulation, dosed once-daily.
These study results are part of an ongoing development program for levomilnacipran, which also includes two additional Phase III studies 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. Based on the overall success of the development program, the companies are preparing to file a new drug application for levomilnacipran with the U.S. Food and Drug Administration (FDA) in the third quarter of 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 by the year 2020.
About Pierre Fabre
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, Glytone, 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., in 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) 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.