Forest Laboratories and Pierre Fabre Laboratories Announce FDA Approval of FETZIMA™ for the Treatment of Major Depressive Disorder in Adults
NEW YORK & CASTRES, France--(BUSINESS WIRE)--
Forest Laboratories, Inc. (NYSE: FRX) and Pierre Fabre Laboratories
announced today that FETZIMA (levomilnacipran extended-release
capsules), a once-daily serotonin and norepinephrine reuptake inhibitor
(SNRI), discovered by Pierre Fabre Laboratories and co-developed by
Forest Laboratories, Inc. was approved by the U.S. Food and Drug
Administration (FDA) for the treatment of Major Depressive Disorder
(MDD) in adults.
Major Depressive Disorder, also known as depression, is a common
debilitating disorder in which feelings of sadness and other symptoms
interfere with a persons ability to work, sleep, study, eat, and enjoy
once-pleasurable activities. MDD affects almost 16 million adults in the
United States every year, with a range of severity from mild to severe.
In the placebo-controlled, pivotal Phase III studies of adult patients
with MDD, statistically significant and clinically meaningful
improvement in depressive symptoms (primary endpoint) was demonstrated
across three FETZIMA dosage strengths of 40, 80, and 120 mg once daily
compared with placebo as measured by the Montgomery Åsberg Depression
Rating Scale (MADRS) total score (primary endpoint). FETZIMA also
demonstrated superiority over placebo as measured by improvement in the
Sheehan Disability Scale (SDS) functional impairment total score
Because people respond differently to different medications, Forest
Laboratories is dedicated to bringing a range of treatment possibilities
to adults living with MDD, as part of our growing mental health
portfolio, said Howard Solomon, Chairman, Chief Executive Officer and
President of Forest Laboratories. The approval of FETZIMA fulfills that
commitment to the millions of people living with MDD.
"We are proud that another product stemming from Pierre Fabres research
has received approval in the United States. This marketing authorisation
represents a key milestone for our laboratory, and it confirms our
choice to make neuropsychiatry a strategic axis of our R&D efforts, next
to oncology and dermatology," said Frédéric Duchesne, President
Pharmaceutical Division, Pierre Fabre Laboratories.
The most common adverse reactions (incidence =5% and at least twice the
rate of placebo) in the placebo-controlled trials were nausea,
constipation, hyperhidrosis, heart rate increased, erectile dysfunction,
tachycardia, vomiting, and palpitations. Rates of adverse events were
generally consistent across doses (40-120 mg); the only dose-related
adverse events (greater than 2% overall incidence) were urinary
hesitation and erectile dysfunction.
As many people with MDD struggle to find a treatment that works for
them, FETZIMA provides patients and physicians with an additional option
for treating this serious disease, said Michael Liebowitz, MD,
Professor of Clinical Psychiatry at Columbia University.
Forest Laboratories Inc. expects FETZIMA to be available to wholesalers
in the 4th calendar quarter 2013.
The efficacy of FETZIMA was demonstrated in three positive double-blind
Phase III studies comprising two fixed-dose studies and one
flexible-dose study that compared FETZIMA to placebo in adults with MDD.
A total of more than 1,600 adult patients received a once-daily dose of
either FETZIMA (40, 80, 120mg) or placebo in the three studies. In each
study, the primary endpoint was change from baseline to endpoint in the
Montgomery Åsberg Depression Rating Scale (MADRS) total score and the
secondary endpoint was change from baseline to endpoint in the Sheehan
Disability Scale (SDS) total score. In all three studies, statistically
significant improvement was seen for the FETZIMA group compared with
placebo on both the primary and secondary endpoints using both the
mixed-effects model for repeated measures (MMRM) and
last-observation-carried-forward (LOCF) analyses.
(Reduction in depressive symptoms)
In all three studies, FETZIMA demonstrated superiority over placebo in
the improvement of depressive symptoms as measured by the change from
baseline to Week 8 in the MADRS total score. MADRS is a widely used,
clinician-rated scale to assess the severity of 10 depressive symptoms.
A total MADRS score of 35 or greater is suggestive of severe depression.
The primary efficacy endpoint in the pivotal trials was change from
baseline to week 8 in the total MADRS score. A 2-point difference
between drug effect and placebo is generally considered to represent a
clinically meaningful improvement in depressive symptoms.
For study 1, the mean baseline MADRS total score was 36 for all
treatment groups. The LS mean difference from placebo in change from
baseline was statistically significant at all three FETZIMA doses (-3.2
at 40 mg/day, -4.0 at 80 mg/day, and -4.9 at 120 mg/day). For study 2,
the mean baseline MADRS total score was 31 for all treatment groups. The
LS mean difference from placebo in change from baseline was
statistically significant at both FETZIMA doses studied (-3.3 at 40
mg/day, -3.1 at 80 mg/day). For study 3, the mean baseline MADRS total
score was 35 for all treatment groups. The LS mean difference from
placebo in change from baseline was statistically significant for the
FETZIMA dosing range studied (-3.1 at 40-120 mg/day).
(Improvement in functional impairment)
FETZIMA also demonstrated superiority over placebo as measured by
improvement in the Sheehan Disability Scale (SDS) functional impairment
total score. SDS is a validated scale that measures the extent that
emotional symptoms disrupt patient functioning in 3 life domains:
work/school, social life, and family life with each item scored from 0
(unimpaired) to 10 (highly impaired).
MDD is a serious medical condition often requiring treatment, affecting
almost 16 million adults in the United States yearly or approximately
7.3% of the adult U.S. population. MDD, also known as depression, is a
common debilitating disorder in which feelings of sadness and other
symptoms occur nearly every day for at least two weeks and interfere
with a persons ability to work, sleep, study, eat, and 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
FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI)
indicated for the treatment of Major Depressive Disorder (MDD). The
recommended therapeutic dose range for FETZIMA is 40 mg to 120 mg once
daily and can be taken with or without food.
While the exact mechanism is unknown, it is thought to be related to the
potentiation of serotonin and norepinephrine in the central nervous
system, through inhibition of reuptake at serotonin and norepinephrine
transporters. Non-clinical studies have shown that FETZIMA is a potent
and selective serotonin and norepinephrine reuptake inhibitor.
Levomilnacipran was licensed to Forest Laboratories Inc. by Pierre
Fabre, in the U.S. and Canada. Pierre-Fabre will also be the active
pharmaceutical ingredient (API) supplier.
for more information on this once-daily option for the treatment of MDD
FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI)
indicated for the treatment of Major Depressive Disorder (MDD).
FETZIMA is not approved for the management of fibromyalgia. Efficacy and
safety of FETZIMA for the management of fibromyalgia have not been
Pierre Fabre Laboratories, the second largest independent pharmaceutical
group in France, achieved a turnover of 1.98 billion Euros in 2012, with
international sales accounting for 54%. Pierre Fabre has branches in 42
countries and its products are distributed in over 130 countries.
Through the holding company Pierre Fabre Participations, 65% of Pierre
Fabre SA is held by the Pierre Fabre Foundation, recognized as a public
utility since 1999. In addition, thanks to an employee shareholding
program set up in 2005, 90% of the companys employees collectively have
a 7 % shareholding interest. This original governance program ensures
the independence and sustainability of the company.
Their activities cover all aspects of healthcare, from prescription
drugs and family health products to dermo-cosmetics. Pierre Fabre
Laboratories employ some 10,000 people worldwide, 1,400 of whom are
dedicated to R&D. Every year, the group allocates 20% of its drug
revenues to R&D, focusing on three main areas: oncology, dermatology and
With brands including Avène, Glytone, A-Derma, Ducray, Galénic, Klorane,
Naturactive, René Furterer or Pierre Fabre Oral Care, Pierre Fabre
Laboratories are Frances market leaders when it comes to skin, hair and
oral care products sold in the pharmacy channel. Avène is marketed in
over 100 countries, and is the leading dermo-cosmetics brand in Europe,
Japan and China. In prescription drugs, Pierre Fabre focuses on four
therapeutic areas: oncology, dermatology, neuropsychiatry and womens
health. In oncology, Pierre Fabre achieves about 90% of its turnover
outside its home country.
In 2012, Pierre Fabre Laboratories was audited by the French
certification group AFNOR at advanced level for its corporate social
responsibility (CSR) performance. To learn more, visit www.pierre-fabre.com.
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. Forests
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 Report 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
Forest Laboratories, Inc.Frank J. Murdolo, 212-224-6714Vice
President Investor Relationsmedia.email@example.com
Source: Forest Laboratories, Inc.