CORRECTING and REPLACING Forest Laboratories, Inc. Announces Commercial Availability of VIIBRYD(TM) in Pharmacies
June 30 2011 - 11:55AM
Business Wire
Please replace the release with the following corrected version
due to multiple revisions.
The corrected release reads:
FOREST LABORATORIES, INC. ANNOUNCES
COMMERCIAL AVAILABILITY OF VIIBRYD(TM) IN PHARMACIES
New Treatment for Major Depressive Disorder in
Adults Now Available in Pharmacies
Forest Laboratories, Inc. (NYSE: FRX) announced today that
VIIBRYD(TM) (vilazodone HCl) tablets is now available at pharmacies
throughout the United States. VIIBRYD is a prescription medicine
indicated for the treatment of adults with Major Depressive
Disorder (MDD).
The U.S. Food and Drug Administration (FDA) approved VIIBRYD as
a new molecular entity on January 21, 2011, making it the first and
only approved selective serotonin reuptake inhibitor (SSRI) and
5HT1A receptor partial agonist. The mechanism of the antidepressant
effect of VIIBRYD is not fully understood but is thought to be
related to its enhancement of serotonergic activity in the central
nervous system (CNS) through selective inhibition of serotonin
reuptake. Vilazodone is also a partial agonist at serotonergic
5HT1A receptors; however, the net result of this action on
serotonergic transmission and its role in vilazodone’s
antidepressant effect are unknown.
The efficacy of VIIBRYD as a treatment for MDD was established
in two 8-week, multicenter, randomized, double-blind,
placebo-controlled studies of 861 adult patients, 436 of whom
received VIIBRYD, and who met the criteria for MDD. In these
studies, patients were titrated over two weeks to a dose of 40 mg
of VIIBRYD once daily with food. VIIBRYD was superior to placebo in
the improvement of depressive symptoms as measured by the mean
change from baseline (95% confidence interval) to week 8 in the
Montgomery-Asberg Depression Rating Scale (MADRS) total score of
-3.2 (-5.2, -1.3) and -2.5 (-4.4, -0.6) for Studies 1 and 2,
respectively.
VIIBRYD was demonstrated to be safe in clinical studies. In the
placebo-controlled, pivotal studies, the most commonly observed
adverse reactions in VIIBRYD-treated patients were diarrhea,
nausea, vomiting and insomnia. No single adverse event led to
discontinuation of treatment in greater than 1% of patients.
Overall, 7.1% of the patients who received VIIBRYD discontinued
treatment due to an adverse reaction, compared with 3.2% of
placebo-treated patients. VIIBRYD has not been associated with any
clinically important changes in laboratory test parameters
including liver function tests, ECG including QT interval or vital
signs. In addition, VIIBRYD had no effect on body weight as
measured by mean change from baseline in the 8-week studies. Among
the common adverse reactions (≥2%) related to sexual function with
VIIBRYD compared to placebo were decreased libido (4% vs
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