New dose of Viibryd approved to treat major depressive disorder in adults

March 19, 2015

FDA has approved a new dose of vilazodone (Viibryd, Actavis) for the treatment of Major Depressive Disorder (MDD) in adults.

FDA has approved a new dose of vilazodone (Viibryd, Actavis) for the treatment of major depressive disorder (MDD) in adults.

Viibryd is an oral antidepressant that acts as a selective serotonin reuptake inhibitor and 5-hydroxytryptamine (5-HT1A) partial agonist. Its antidepressant activity is due to blockade of serotonin reuptake at the presynaptic neuronal membrane. Viibryd was first approved in January 2011 for the treatment of MDD in adults at a dose of 40 mg/day. FDA has now approved a 20 mg dose which fulfills a post-marketing commitment with the FDA to identify the minimum effective dose.

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MDD is a serious debilitating disorder that currently affects almost 16 million adults in the United States. People suffering from MDD, also known as depression, may experience loss of interest in activities, mood disturbance, and a range of cognitive, emotional, behavioral and physical symptoms. MDD is a leading cause of disability in the United States among all medical illnesses.

The lower dose approval was based on a 10-week, multicenter trial of 1133 adult patients with MDD. Compared with placebo, Viibryd showed significant reductions in illness severity which was determined by the mean change in Montgomery-Asberg Depression Rating Scale (MADRS) as well as the change from baseline on the Clinical Global Impressions-Severity scale (CGI-S). The results support the efficacy, safety, and tolerability of the 20-mg dose of Viibryd in the treatment of adults with MDD.

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Diarrhea, nausea, insomnia and vomiting are the most common side effects associated with the use of Viibryd in adults. Viibryd is not indicated for use in patients under aged 18 years.