FDA Approves Vilazodone to Treat Major Depressive Disorder in Adults

Neil Osterweil

January 24, 2011

January 24, 2011 (UPDATED January 31, 2011) — The US Food and Drug Administration (FDA) has approved vilazodone tablets (Viibryd, Clinical Data, Inc) for the treatment of major depressive disorder (MDD) in adults.

Vilazodone is the first approved drug that is both a combination selective serotonin reuptake inhibitor (SSRI) and a partial agonist of serotonergic (5HT1A) receptors. Its mechanism of action "is not fully understood but is thought to be related to its enhancement of serotonergic activity in the central nervous system through selective inhibition of serotonin reuptake," according to a press release from Clinical Data, which holds worldwide marketing rights for the drug.

"While there are currently available treatments for MDD, no one therapy works for every patient and side effect profiles vary, which may impact both compliance and treatment success," said Carol R. Reed, MD, executive vice president and chief medical officer of Clinical Data. "Viibryd will be a new choice for healthcare providers and their patients who are suffering from depression."

In 2 randomized, double-blind trials in adults with MDD, vilazodone 40 mg once daily was shown to be significantly superior to placebo at improving depressive symptoms, as measured by a mean change in the Montgomery-Asberg Depression Rating Scale total score from baseline to week 8. Patients in the study were titrated up to the 40-mg dose during the course of 2 weeks.

In safety studies involving 2177 patients diagnosed with MDD, the most common adverse events were diarrhea, nausea, vomiting, and insomnia. In all, 7.1% of patients who received vilazodone discontinued treatment because of an adverse reaction compared with 3.2% of control patients. The drug was not associated with change in body weight at 8 weeks, and there were no reported drug-related abnormalities in hepatic or cardiac parameters or vital signs, the company says.

Reported adverse effects on sexual function included decreased libido in 4% compared with in less than 1% of control patients, abnormal orgasm (3% vs 0%), delayed ejaculation (2% vs 0%), and erectile dysfunction (2% vs 1%).

"When treating MDD, our goal is to offer treatment options that meet the individual needs of each patient," said Stephen M. Stahl, MD, PhD, professor of psychiatry, University of California–San Diego. "Viibryd is an important new treatment option with proven efficacy and a demonstrated safety profile."

The drug will be dispensed in 10-, 20-, and 40-mg tablets, with planned availability in the second quarter of 2011. The recommended dose is 40 mg once daily, titrated upward to that dose by starting with an initial dose of 10 mg once daily for 7 days, followed by 20 mg once daily for an additional 7 days, and then increased to 40 mg once daily. It should be taken with food to achieve adequate drug concentrations. When treatment is discontinued, the dose should be reduced gradually.

As with other antidepressants, the labeling will carry a boxed warning about increased risk for suicidality and suicidal behavior in children, adolescents, and young adults, the company says.

Because controlled human data regarding vilazodone use during pregnancy are lacking, it should be used in pregnant women only if the potential benefits outweigh the potential risks. Similarly, there are no human data concerning vilazodone concentrations in breast milk, so women taking vilazodone should breast-feed only if the potential benefits outweigh the potential risks.

The safety and efficacy of vilazodone in pediatric patients have not been studied, but for geriatric use, no dose adjustment is recommended based on age. Although no dose adjustment is recommended in patients with mild, moderate, or severe renal impairment, or in patients with mild or moderate hepatic impairment, vilazodone has not been studied in patients with severe hepatic impairment.

More information is available on the FDA Drug Web site .

Laurie Barclay, MD, contributed to this news article.


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