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Vilazodone (Viibryd) Shows Promise as Anxiety Treatment in Phase III Studies

Trials meet primary endpoint of improved HAM-A scores

Positive results have been reported from three phase III studies that evaluated the efficacy, safety, and tolerability of vilazodone (Viibryd, Forest Laboratories) in adult patients with generalized anxiety disorder (GAD).

In two flexible-dose and one fixed-dose studies, GAD patients who received vilazodone demonstrated statistically significant improvements from baseline in the Hamilton Rating Scale for Anxiety (HAM-A) total score compared with those given placebo at week 8 (the studies’ primary endpoint).

Based on these results, a new drug application for vilazodone is expected to be submitted to the FDA in 2015 for the treatment of GAD. The drug is currently indicated for use in adults with major depressive disorder.

The MD-07 trial — a randomized, double-blind, placebo-controlled, parallel-group, flexible-dose, 8-week phase III study — evaluated the efficacy, safety, and tolerability of vilazodone in adult patients with GAD. After a 7-day screening period, 415 patients aged 18 to 70 years were randomly assigned to receive vilazodone (20–40 mg/day) or placebo followed by a 1-week down-taper safety period. The study’s primary endpoint was the change in the HAM-A total score from baseline to the end of week 8.

Statistically significant improvement in the HAM-A total score was observed in the vilazodone group compared with the placebo group (least squares mean difference [LSMD]: –2.2; P = 0.0048). The most common adverse events in the vilazodone group were nausea, diarrhea, headache, and dizziness.

The MD-06 trial — another randomized, double-blind, placebo-controlled, parallel-group, flexible-dose, 8-week phase III study — evaluated the efficacy, safety, and tolerability of vilazodone in adult patients with GAD. After a 7-day screening period, 402 patients 18 to 70 years of age were randomly assigned to receive vilazodone (20–40 mg/day) or placebo followed by a 1-week down-taper safety period. As in the MD-07 study, the primary endpoint was the change in the HAM-A total score from baseline to the end of week 8.

Statistically significant improvement in the HAM-A total score was observed in the vilazodone group compared with the placebo group (LSMD: –1.50; P = 0.0438). The most common adverse events in the vilazodone group included nausea and diarrhea.

The MD-05 trial — a randomized, double-blind, placebo-controlled, parallel-group, fixed-dose, 8-week, phase III study — evaluated the efficacy, safety, and tolerability of vilazodone in adult patients with GAD. After a 7-day screening period, 680 patients 18 to 70 years old were randomly assigned to receive vilazodone 20 mg/day, vilazodone 40 mg/day, or placebo followed by a 1-week down-taper safety period. The study’s primary endpoint was the change in the HAM-A total score from baseline to end of week 8.

Statistically significant improvement in the HAM-A total score was observed in the vilazodone 40 mg/day group compared with the placebo group (LSMD: –1.8; P = 0.0312). For both vilazodone groups, the most common adverse events were nausea, diarrhea, and headache.

Vilazodone is a selective serotonin reuptake inhibitor (SSRI) and a 5-hydroxytryptamine (5-HT1A) receptor partial agonist.

Source: Forest Laboratories; June 23, 2014.

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