Clinical Data (CLDA) Announces Positive Results from Second Phase III Trial of Vilazodone for Depression

June 2, 2009 8:55 AM EDT

Clinical Data, Inc. (NASDAQ: CLDA) announced positive top-line results from the second of two Phase III trials of its investigational compound, vilazodone, for the treatment of major depressive disorder (MDD). In the study, vilazodone achieved statistically significant results on the primary endpoint and secondary efficacy endpoints related to MDD. Study results suggest that vilazodone was generally well-tolerated and the efficacy and safety data were consistent with the findings from the previous Phase III trial. In addition, study findings corroborate that effects of vilazodone on sexual function were comparable to placebo, an important finding since many antidepressants have been associated with causing or exacerbating sexual dysfunction. A statistically significant improvement in the symptoms of anxiety associated with MDD was also observed. Clinical Data intends to file these data as the second of two positive registration studies in support of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for vilazodone for the treatment of MDD by the end of 2009.

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