FDA approves vilazodone HCl for MDD

FDA has approved vilazodone HCl tablets (Viibryd, Clinical Data) for the treatment of adults with major depressive disorder (MDD). Viibryd is a new molecular entity and the first and only selective serotonin reuptake inhibitor and 5HT1A receptor partial agonist.

The efficacy of Viibryd as a treatment for MDD was established in two 8-week, multicenter, randomized, double-blind, placebo-controlled studies in adults who met the criteria for MDD. In these studies, patients were titrated over 2 weeks to a dose of 40 mg of Viibryd once daily. Viibryd was superior to placebo in the improvement of depressive symptoms as measured by the mean change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale total score.

Vilazodone use did not cause significant weight gain or the negative impact on sexual desire or function seen with many other antidepressants that has led many patients to abandon their medication.

“As the newest entrant into the crowded category of antidepressant agents, Viibryd offers a unique dual mechanism of activity that may prove advantageous in patients not responding to current standards of care,” said Formulary Clinical Editor David Calabrese, RPh, MHP.

“Its true positioning, however, among present-day therapeutic options will largely be dictated by more broad use in a real-world clinical setting and various pharmacoeconomic considerations,” added Calabrese, chief clinical officer, Med Metrics Health Partners, Worcester, Mass.

Clinical Data plans to make Viibryd available in US pharmacies in the second quarter of this year.