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.
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
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.
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
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.
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