Forest Laboratories Submits New Drug Application for Levomilnacipran for the Treatment of Major Depressive Disorder
September 27 2012 - 2:00AM
Business Wire
Forest Laboratories, Inc. (NYSE: FRX) and Pierre Fabre
Laboratories today announced that Forest has submitted a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
for levomilnacipran, a serotonin norepinephrine reuptake inhibitor
(SNRI) for the treatment of Major Depressive Disorder (MDD) in
adults. Levomilnacipran was discovered by Pierre Fabre and jointly
developed by Forest Laboratories and Pierre Fabre, under a
licensing agreement in the U.S. and Canada. Pierre Fabre will be
the active pharmaceutical ingredient (API) supplier.
The application includes results from three positive Phase III
studies comprising two double-blind, fixed-dose studies and one
flexible-dose study evaluating the efficacy of levomilnacipran
compared with placebo in adults with MDD. A total of more than
1,600 adult patients received a once-daily dose of either
levomilnacipran (40, 80, 120mg) or placebo in the three studies. In
each of the three studies, statistically significant improvement
was seen for the levomilnacipran group compared with placebo in the
primary and secondary endpoints (change from baseline to endpoint
in the Montgomery-Åsberg Depression Rating Scale total score and
Sheehan Disability Scale total score, respectively) using the
mixed-effects model for repeated measures and
last-observation-carried-forward analyses.
Additionally, safety data collected from the Phase III program
demonstrated that levomilnacipran 40, 80, 120mg once daily was
generally well tolerated, with an incidence of adverse reactions
that was consistent across the study treatment arms. The most
commonly reported adverse reaction (≥10% and twice the rate of
placebo) observed in the levomilnacipran group was nausea.
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. An SNRI,
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 has been developed as a
sustained-release formulation, dosed once daily.
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 by the year 2020.
About Pierre Fabre Laboratories
Pierre Fabre, the second largest independent pharmaceutical
group in France, achieved a turnover of 1.9 billion Euros in 2011,
with international sales accounting for 52%. Pierre Fabre has
branches in 42 countries and markets its products in over 130
countries. Their activities cover all aspects of healthcare, from
prescription drugs and family health products to dermo-cosmetics.
The Pierre Fabre Laboratories employ some 10,000 people worldwide,
1,300 of whom are dedicated to R&D. In 2011, the group
allocated 20% of its Pharmaceuticals business revenues to R&D,
focusing on four main areas: oncology, dermatology, neuropsychiatry
and women’s health. With brands including Avène, A-Derma, Ducray,
Glytone, Klorane, René Furterer, Pierre Fabre Dermatology or Pierre
Fabre Oral Care, Pierre Fabre is market leader in France when it
comes to cosmetics, hair care, oral products and dermatological
products sold in pharmacies. Avène is marketed in over 100
countries, and is the leading dermo-cosmetics brand sold in Europe,
Japan and China. In the oncology area, 85% of Pierre Fabre’s sales
are achieved outside France. 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, respiratory,
gastrointestinal, and pain management medicine. Forest’s pipeline,
the most robust in its history, includes product candidates in all
stages of development across a wide range of therapeutic areas.
Forest 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 assumes no
obligation to update forward looking statements contained in this
release to reflect new information or future events or
developments.
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