Forest Laboratories, Inc. (NYSE:FRX) today announced positive
topline results from three Phase III trials evaluating the
efficacy, safety and tolerability of vilazodone in adult patients
with generalized anxiety disorder (GAD). In two flexible-dose and
one fixed-dose GAD trials, patients who received vilazodone
demonstrated statistically significant improvement from baseline in
the Hamilton Rating Scale for Anxiety (HAM-A) total score versus
placebo at week 8, the primary endpoint.
“Forest is committed to helping people living with generalized
anxiety disorder and other mental health conditions. We have a
growing mental health portfolio and are one step closer to one day
offering general anxiety patients a new treatment option to help
manage this condition,” said Marco Taglietti, M.D., Chief Medical
Officer and EVP, Drug Development and Research at Forest
Laboratories, Inc.
Based on these results, the Viibryd supplemental New Drug
Application (sNDA) for the treatment of GAD will be filed with the
FDA in 2015.
About the flexible-dose Phase III Study (MD-07)
This multicenter, randomized, double-blind, placebo-controlled,
parallel-group, flexible-dose, 8-week Phase III study evaluated the
efficacy, safety, and tolerability of vilazodone as treatment in
adult patients with GAD. Eligible patients were those who met
Diagnostic and Statistical Manual of Mental Disorders, Fourth
Edition, Text Revision (DSM-IV-TR) criteria for GAD, and had a
minimum total score of 20 on the HAM-A scale. Following a 7 day
screening period, a total of 415 patients between 18 and 70 years
of age were randomized to one of two treatment groups (vilazodone
20 - 40 mg/day, or placebo) followed by a 1-week down-taper safety
period. The primary endpoint was defined as change from baseline to
end of week 8 in the HAM-A total score. Statistically significant
improvement in the HAM-A total score was observed in the vilazodone
20 - 40 mg/day group relative to the placebo group (Least squares
mean difference (LSMD): vilazodone 20 - 40 mg/day: -2.2, p=0.0048)
using a mixed-effect model for repeated measures (MMRM). Most
common adverse events in the vilazodone 20-40 mg/day group
(incidence ≥10 % and greater than placebo) were nausea, diarrhea,
headache, and dizziness.
About the flexible-dose Phase III Study (MD-06)
This multicenter, randomized, double-blind, placebo-controlled,
parallel-group, flexible-dose, 8-week Phase III study evaluated the
efficacy, safety, and tolerability of vilazodone as treatment in
adult patients with GAD. Eligible patients were those who met
Diagnostic and Statistical Manual of Mental Disorders, Fourth
Edition, Text Revision (DSM-IV-TR) criteria for GAD, and had a
minimum total score of 20 on the HAM-A scale. Following a 7 day
screening period, a total of 402 patients between 18 and 70 years
of age were randomized to one of two treatment groups (vilazodone
20 - 40 mg/day, or placebo) followed by a 1-week down-taper safety
period. The primary endpoint was the change from baseline to end of
week 8 in the HAM-A total score. Statistically significant
improvement in the HAM-A total score was observed in the vilazodone
20 - 40 mg/day group relative to the placebo group (Least squares
mean difference (LSMD): vilazodone 20 - 40 mg/day: -1.50,
p=0.0438;) using a mixed-effect model for repeated measures (MMRM).
Most common adverse events in the vilazodone 20-40 mg/day group
(incidence ≥10 % and greater than placebo) were nausea, and
diarrhea.
About the fixed-dose Phase III Study (MD-05)
This multicenter, randomized, double-blind, placebo-controlled,
parallel-group, fixed-dose, 8-week Phase III study evaluated the
efficacy, safety, and tolerability of vilazodone as treatment in
adult patients with GAD. Eligible patients were those who met
Diagnostic and Statistical Manual of Mental Disorders, Fourth
Edition, Text Revision (DSM-IV-TR) criteria for GAD, and had a
minimum total score of 20 on the HAM-A scale. Following a 7 day
screening period, a total of 680 patients between 18 and 70 years
of age were randomized to one of three treatment groups (either
vilazodone 20 or 40 mg/day, or placebo) followed by a 1-week,
down-taper safety period. The primary endpoint was the change from
baseline to end of week 8 in the HAM-A total score. Statistically
significant improvement in the HAM-A total score was observed in
the vilazodone 40 mg/day group relative to the placebo group (Least
squares mean difference (LSMD): vilazodone 20 mg/day: -1.3,
p=0.0830; vilazodone 40 mg/day: -1.8, p=0.0312) using a
mixed-effect model for repeated measures (MMRM). For both
vilazodone dose groups the most common adverse events (incidence
≥10% and greater than placebo) were nausea, diarrhea, and
headache.
About Vilazodone
Vilazodone, also known by its brand name VIIBRYD, is a selective
serotonin reuptake inhibitor (SSRI) and 5-HT1A receptor partial
agonist approved by the FDA for the treatment of adults with Major
Depressive Disorder MDD.
Visit VIIBRYD.com for more
information.
About Generalized Anxiety Disorder
Anxiety disorders are the most common mental illness in the
U.S., affecting 40 million adults in the United States age 18 and
older (18% of U.S. population), and cost the U.S. more than $42
billion a year. The prevalence of generalized anxiety disorder
(GAD) is estimated to be 6.8 million adults or 3.1% of the U.S.
population, and it affects women twice as often as men. According
to The Diagnostic and Statistical Manual of Mental Disorders
(DSM-V), the essential features of GAD are excessive anxiety and
worry (apprehensive expectation) about everyday events or
activities for a period of six months or more. Anxiety and worry
can also be associated with physical symptoms that cause
significant distress and affect daily functioning. For a diagnosis
to be made, worry must be present more days than not for at least
six months. GAD frequently co-occurs with mood disorders, including
depression. Additionally, up to 80% of people suffering from
depression also experience symptoms of anxiety. Anxiety disorders
are highly treatable, yet only about one-third of those suffering
receive treatment.
About Forest Laboratories, Inc.
Forest Laboratories (NYSE:FRX) is a leading, fully integrated,
specialty pharmaceutical company largely focused on the United
States market. Forest markets a portfolio of branded drug products
and develops new medicines to treat patients suffering from
diseases principally in five therapeutic areas: central nervous
system, cardiovascular, gastrointestinal, respiratory, and
anti-infective. Forest’s strategy of acquiring product rights for
development and commercialization through licensing, collaborative
partnerships and targeted mergers and acquisitions allows Forest to
take advantage of attractive late-stage development and commercial
opportunities, thereby managing the risks inherent in drug
development. In January 2014, Forest acquired Aptalis
Pharmaceuticals for $2.9 billion in cash in order to gain access to
its GI and Cystic Fibrosis products, including treatments for
Ulcerative Proctitis, Duodenal Ulcers, H. Pylori, Anal Fissures,
and Pancreatic Insufficiency. In February 2014, Forest and Actavis
plc announced an agreement where Forest would be acquired for about
$25 billion in cash and stock. The acquisition of Forest by Actavis
is contingent upon regulatory and shareholder approvals.
Forest is headquartered in New York, NY.
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 developments.
Forest Laboratories, Inc.Media Relations:Amanda Kaufman,
646-231-7316amanda.kaufman@frx.comorInvestor Relations:Frank J.
Murdolo, 212-224-6714,media.relations@frx.com
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