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Original Research

Vilazodone: Clinical Basis for the US Food and Drug Administration’s Approval of a New Antidepressant

Thomas P. Laughren, MD; Jogarao Gobburu, PhD; Robert J. Temple, MD; Ellis F. Unger, MD; Atul Bhattaram, PhD; Phillip V. Dinh, PhD; Linda Fossom, PhD; H. M. James Hung, PhD; Violetta Klimek, PhD; Jee Eun Lee, PhD; Robert L. Levin, MD; Cheri Y. Lindberg, MD; Mitchell Mathis, MD; Barry N. Rosloff, PhD; Sue-Jane Wang, PhD; Yaning Wang, PhD; Peiling Yang, PhD; Bei Yu, PhD; Huixia Zhang, PhD; Li Zhang, PhD; and Issam Zineh, PharmD

Published: September 15, 2011

Article Abstract

Objective: Vilazodone was recently approved by the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD). The purpose of this review is to summarize the FDA’s approach to its review of the clinical pharmacology and the clinical efficacy and safety data for this new drug application, important issues in its decision-making, and its conclusions.

Data Sources: The data sources for this review were the original raw data sets for all clinical trials included in the development program for vilazodone, as well as the sponsor’s original analyses of these data.

Study Selection: Data were available from 24 human trials involving vilazodone, and included a total of 2,898 human subjects exposed to 1 or more doses of this drug.

Data Extraction: The FDA had access to original raw data sets for these trials.

Results: Vilazodone is effective in treating MDD at a dose of 40 mg/d, but it needs to be incrementally adjusted to this dose to minimize gastrointestinal symptoms. It needs to be taken with food to ensure adequate plasma concentrations. Vilazodone’s profile of adverse events is similar to that seen with selective serotonin reuptake inhibitors. No dose adjustment is needed based on age, gender, or renal or hepatic impairment. It is recommended that the vilazodone dose be reduced to 20 mg when it is taken with strong cytochrome P450 (CYP) 3A4 inhibitors, eg, ketoconazole. Vilazodone is not expected to have important effects on the clearance of other drugs that are cytochrome P450 substrates.

Conclusions: Vilazodone is a new treatment for MDD, but it is unknown whether it has any advantages compared to other drugs in the antidepressant class.

J Clin Psychiatry 2011;72(9):1166-1173

Submitted: March 3, 2011; accepted April 29, 2011(doi:10.4088/JCP.11r06984).

Corresponding author: Thomas P. Laughren, MD, Director, Division of Psychiatry Products, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993 (

Volume: 72

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