Clinical Data completes NDA submission for vilazodone

Clinical Data, Inc. (NASDAQ: CLDA), today announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vilazodone for the treatment of major depressive disorder (MDD). Vilazodone is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT_1A receptor partial agonist. The Company expects that the NDA submission, if accepted, will be subject to a standard review.

“This is an extraordinary accomplishment for Clinical Data to complete our NDA submission for vilazodone and to meet our goal by delivering it to the FDA this quarter, as promised”

“This is a major milestone in the development of vilazodone and, if approved, its dual mechanism of action and safety profile will offer a new alternative for patients suffering from depression,” said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. “We are very encouraged by the results seen to date in vilazodone’s clinical development and look forward to working with the Agency during the review process.”

The NDA submission is based on a comprehensive development program for vilazodone, which includes two randomized, double-blind, placebo-controlled Phase III 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 III studies, most adverse events were mild to moderate in intensity and consistent with vilazodone’s expected pharmacologic effect; the most common adverse reactions included diarrhea, nausea and insomnia. Typically, these adverse reactions occurred early in treatment and did not result in discontinuation of treatment with vilazodone. Overall, vilazodone has been shown to have a good safety profile and to be well tolerated in a database of nearly 2,900 patients treated for up to 52 weeks.

“This is an extraordinary accomplishment for Clinical Data to complete our NDA submission for vilazodone and to meet our goal by delivering it to the FDA this quarter, as promised,” said Drew Fromkin, Clinical Data’s President and Chief Executive Officer.