Clinical Data Inc. announced that a New Drug Application (NDA) has been submitted to the FDA seeking approval of vilazodone for the treatment of major depressive disorder (MDD). This submission is based on a comprehensive development program for vilazodone, which includes two randomized, double-blind, placebo-controlled Phase 3 clinical trials. In both of these eight-week trials, the efficacy of vilazodone was substantiated as shown by its superiority to placebo, with statistically significant results for the primary and multiple secondary endpoints. Results from efficacy measures in an uncontrolled long-term safety study were consistent with these findings. In Phase 3 studies, most adverse events were mild to moderate in intensity and consistent with vilazodone’s expected pharmacologic effect.
Vilazodone is a potential first-in class drug for the treatment of depression due to its novel dual mechanism of action as both a potent and selective serotonin reuptake inhibitor (SSRI) and a partial agonist of the 5-hydroxytryptamine 1a (5-HT1A) receptor.
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