Forest Laboratories, Inc. & Pierre Fabre Medicament Announce Positive Phase III Results For Levomilnacipran in Patients with ...
March 07 2012 - 2:00AM
Business Wire
Forest Laboratories, Inc. (NYSE: FRX) and Pierre Fabre
Medicament today announced 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.
About Levomilnacipran
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.
About MDD
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) 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.
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