Vilazodone approved for major depression

Abstract

Clinical Data Inc. of Newton, Massachusetts, on January 24 announced the approval of vilazodone hydrochloride oral tablets for the treatment of adults with major depressive disorder. The drug will be marketed as Viibryd by Clinical Data subsidiary Trovis Pharmaceuticals, formerly known as PGxHealth, and will be available during the second quarter of this year. According to the FDA-approved labeling for vilazodone, the drug is a selective serotonin reuptake inhibitor and serotonin type 1A-receptor partial agonist. The labeling states that vilazodone’s mechanism of action is unknown but may result from an increase in serotonergic activity in the central nervous system. Labeling for vilazodone includes a boxed warning and medication guide that describe an increased risk of suicidal thinking in children, adolescents, and young adults who use antidepressants. The warning emphasizes that vilazodone is not indicated for pediatric use. The drug is contraindicated in patients who take monoamine oxidase inhibitors (MAOIs) and should not be taken within 14 days of starting or stopping an MAOI. Concomitant treatment with vilazodone and an MAOI may increase the risk of serotonin syndrome, according to vilazodone’s labeling.