FDA OKs Lower Dose of Depression Drug

The FDA has approved a 20 mg dose of Actavis’s vilazodone HCl (Viibryd), which is now available in pharmacies to treat adult patients with major depressive disorder (MDD).

The selective serotonin reuptake inhibitor was originally approved by the FDA in January 2011 at a dose of 40 mg/day. This new approval adds a 20 mg dosing option, which fulfills a post-marketing commitment to identify the minimum effective dose of Viibryd.

Viibryd should be taken with food and initiated at a dose of 10 mg once daily for 7 days, followed by 20 mg once daily. Based on efficacy and tolerability, the dose may be increased to 40 mg daily after a minimum of 7 days between dosage increases.

The efficacy, safety, and tolerability of the 20 mg dose was supported by a 10-week trial of 1133 adults with MDD, which found significantly greater reduction in mean Montgomery-Asberg Depression Rating Scale (MADRS) total scores from baseline in vilazodone treatment groups compared with placebo. In addition, vilazodone dose groups significantly reduced illness severity compared with placebo as measured by the change from baseline in Clinical Global Impressions-Severity (CGI-S) scale score.

For both the MADRS total score and CGI-S score, significant differences in favor of the vilazodone groups were observed as early as week 2 and were maintained through week 10.

Adverse events that occurred in at least 5% of patients in either vilazodone dose group and at twice the rate of placebo were diarrhea, nausea, insomnia, and vomiting.