However, a subsequent phase III clinical trial demonstrated statistical significance against placebo for 410 patients with MDD. A new FDA drug application was made in 2009 (Bear Stearns Healthcare Conference; Newton, Massachusetts, USA; Business Wire, September 2007). Secondary, regulatory trials again showed efficacy and tolerability and vilazodone was FDA approved for MDD in January 2011. The official company data and FDA Package Insert reveal the positive regulatory, confirmatory trial information. At the time of this article, two peer-reviewed Inhibitors,research,lifescience,medical papers outline randomized, controlled trial in which 891 patients were studied. Significant improvements

in multiple depression rating Inhibitors,research,lifescience,medical scales were noted when compared with placebo. Diarrhea, nausea, and somnolence were the greatest side effects noted [Khan et al. 2011]. There were clinically no significant differences for men or women in regards to sexual dysfunction fairly outcome measures [Rickels et al. 2009]. Vilazodone efficacy in MDD was further established in two 8-week, multicenter, randomized, double-blind, placebo-controlled studies in adult (18–70 years

of age) outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) [APA, Inhibitors,research,lifescience,medical 2000] criteria for MDD. Vilazodone was superior to placebo in the improvement of depressive symptoms, and evaluation of population subgroups based on age, gender, and

race did not reveal any clear evidence Inhibitors,research,lifescience,medical of differential responsiveness. The most common side effects of vilazodone over placebo included diarrhea, nausea, and dry mouth and it does carry an increased lethality warning in young adult patients. It is not approved for pediatric depression. No blood laboratory or electrocardiogram changes were noted and no tests are required while administering this ADT. In these acute 8-week studies no abnormal weight gain or metabolic adverse effects were noted [Forest Pharmaceuticals, 2011]. Long-term, 52-week data are not available as yet. Finally, sexual dysfunction Inhibitors,research,lifescience,medical adverse effects were minimal (1–2% over placebo rates) [Stahl, 2011]. Other clinical applications Given that other agents with SSRI activity and 5HT1A receptor activity carry FDA approval for depression, Anacetrapib generalized anxiety disorder, obsessive—compulsive disorder, social anxiety disorder, panic disorder, post-traumatic stress disorder (PTSD), eating disorders, and premenstrual disorders [Stahl, 2011, 2008], it would follow that vilazodone conceptually has the pharmacodynamic mechanisms necessary to alleviate symptoms attributed to these disorders as well. Interestingly, one animal model study conducted by Adamec and colleagues [Adamec et al. 2004] revealed that rodents treated with therapeutic levels of vilazodone had fewer poststress (predator-induced) clinical symptoms.