title: Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant.
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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: Division of Psychiatry Products, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA. thomas.laughren@fda.hhs.gov
authors.forename: Thomas P
authors.initials: TP
authors.lastname: Laughren
authors.forename: Jogarao
authors.initials: J
authors.lastname: Gobburu
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Temple
authors.forename: Ellis F
authors.initials: EF
authors.lastname: Unger
authors.forename: Atul
authors.initials: A
authors.lastname: Bhattaram
authors.forename: Phillip V
authors.initials: PV
authors.lastname: Dinh
authors.forename: Linda
authors.initials: L
authors.lastname: Fossom
authors.forename: H M James
authors.initials: HM
authors.lastname: Hung
authors.forename: Violetta
authors.initials: V
authors.lastname: Klimek
authors.forename: Jee Eun
authors.initials: JE
authors.lastname: Lee
authors.forename: Robert L
authors.initials: RL
authors.lastname: Levin
authors.forename: Cheri Y
authors.initials: CY
authors.lastname: Lindberg
authors.forename: Mitchell
authors.initials: M
authors.lastname: Mathis
authors.forename: Barry N
authors.initials: BN
authors.lastname: Rosloff
authors.forename: Sue-Jane
authors.initials: SJ
authors.lastname: Wang
authors.forename: Yaning
authors.initials: Y
authors.lastname: Wang
authors.forename: Peiling
authors.initials: P
authors.lastname: Yang
authors.forename: Bei
authors.initials: B
authors.lastname: Yu
authors.forename: Huixia
authors.initials: H
authors.lastname: Zhang
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
authors.forename: Issam
authors.initials: I
authors.lastname: Zineh
mesh_terms: D001572:Benzofurans / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D017327:Clinical Trials, Phase IV as Topic; D003865:Major Depressive Disorder / Q000188:drug therapy*; D017277:Drug Approval; D005260:Female; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008297:Male; D010879:Piperazines / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D012735:Sexual Dysfunction, Physiological / Q000139:chemically induced; D014481:United States; D014486:United States Food and Drug Administration; D000069503:Vilazodone Hydrochloride
chemical_list: D001572:Benzofurans; D007211:Indoles; D010879:Piperazines; D017367:Selective Serotonin Reuptake Inhibitors; D000069503:Vilazodone Hydrochloride