Clinical Data, Inc. (NASDAQ: CLDA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for vilazodone for the treatment of major depressive disorder (MDD). Vilazodone is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist. The NDA will be subject to a standard review.
“The acceptance of the NDA for review by the FDA is another positive step toward our goal of bringing vilazodone to market, and if approved, vilazodone will offer a novel treatment to the millions of people suffering from depression”
"The acceptance of the NDA for review by the FDA is another positive step toward our goal of bringing vilazodone to market, and if approved, vilazodone will offer a novel treatment to the millions of people suffering from depression," said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data.
The NDA submission is based on a comprehensive development program for vilazodone, which included two randomized, double-blind, placebo-controlled Phase III clinical trials. In both of these eight-week trials, the efficacy of vilazodone was shown to be superior to placebo with statistically significant results for the primary endpoint and for multiple secondary measures of the symptoms of depression. Results from efficacy measures in an uncontrolled 52-week study were consistent with these findings. The NDA is supported by a database of nearly 2,900 subjects.
Vilazodone was licensed from Merck Serono, a division of Merck KGaA, Darmstadt, Germany. Under the terms of Clinical Data's license agreement with Merck Serono, the FDA's acceptance of the NDA for vilazodone gives rise to a milestone payment to Merck KGaA of €12.5 million (or $15.6 million at May 21, 2010, the NDA acceptance date), payable in 920,901 shares of Clinical Data common stock to be issued within 30 days of the NDA acceptance date. All of the shares issued to Merck KGaA with respect to this milestone payment will be unregistered but carry certain demand and incidental registration rights as provided under the license agreement.