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Home » Drug Information » FDA Approved Drugs » 2011
Medical Areas: Neurology | Psychiatry/Psychology | Family Medicine

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Viibryd (vilazodone hydrochloride)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Clinical Data
Approval Status: Approved January 2011
Treatment Area: major depressive disorder

General Information

Viibryd (vilazodone hydrochloride) is a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. The mechanism of the antidepressant effect of vilazodone is not fully understood

Viibryd is specifically indicated for the treatment of major depressive disorder.

The recommended initial dose of Viibryd is 40 mg once daily. Treatment should be titrated, 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 an increase to 40 mg once daily.

Clinical Results

FDA Approval
The FDA approval of Viibryd was based on two 8-week, multicenter, randomized, double-blind, placebo-controlled studies in adults meeting the criteria for major depressive disorder. The subjects were titrated over two weeks to a dose of 40 mg (n=436) or placebo (n = 433) 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 (MADRS) total score. In Study 1, the Least Squares Mean difference from placebo in change from baseline was -3.2 and in Study 2, the difference was -2.5.

Side Effects

Adverse events associated with the use of Viibryd may include, but are not limited to, the following:

  • diarrhea
  • nausea
  • vomiting
  • insomnia

Mechanism of Action

Viibryd (vilazodone hydrochloride) is a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. The mechanism of the antidepressant effect of vilazodone is not fully understood but is thought to be related to its enhancement of serotonergic activity in the CNS through selective inhibition of serotonin reuptake. Vilazodone is also a partial agonist at serotonergic 5-HT1A receptors; however, the net result of this action on serotonergic transmission and its role in vilazodone’s antidepressant effect are unknown.

Literature References

Rickels K, Athanasiou M, Robinson DS, Gibertini M, Whalen H, Reed CR Evidence for efficacy and tolerability of vilazodone in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled trial. The Journal of Clinical Psychiatry 2009 Mar;70(3):326-33. Epub 2009 Mar 10

Additional Information

For additional information regarding Viibryd or major depressive disorder, please visit the Viibryd web page.