Clinical Data Announces Results From Vilazodone Trial

Clinical Data reported positive results in its pivotal Phase III study of its investigative compound Vilazodone, a potential treatment for depression.

The randomized, double-blind, placebo-controlled, ten-site trial enrolled 410 adult patients with major depressive disorder.  In the study, the primary and supportive secondary efficacy endpoints were met, Clinical Data said.

The company added that the study separately identified candidate biomarkers for a potential companion pharmacogenetic test for response to Vilazodone.

Vilazodone combines the mechanisms of action of both a selective serotonin reuptake inhibitor and a 5HT1A partial agonist, making it the only compound that combines two mechanisms used as first and second line treatments for mood disorders, the company said, adding that the safety profile appears to be similar to currently marketed SSRIs.