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Viibryd now commercially available in pharmacies

June 30, 2011
by News release
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New York — Forest Laboratories, Inc., has announced that Viibryd (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 5-HT1A 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 the placebo-treated patients. Viibryd has not been associated with any clinically significant 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 <1%), abnormal orgasm (3% vs 0%), delayed ejaculation (2% vs 0%, males only) and erectile dysfunction (2% vs 1%, males only).

MDD is a serious medical condition requiring treatment, which affects more than 15 million adults in the United States yearly or approximately 6.5% of the adult U.S. population.

A person diagnosed with MDD exhibits a combination of symptoms that interfere with one's ability to work, sleep, study, eat and enjoy once-pleasurable activities. Despite the seriousness of the condition, nearly 50 percent of people with MDD do not receive treatment.

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