Vilazodone enters long-term safety trial ahead of schedule

Clinical Data, a US firm developing targeted therapeutics and predictive tests, has initiated a long-term safety study for vilazodone, its dual serotonergic antidepressant, ahead of schedule. The trial will test the long-term safety and tolerability of the agent and will enroll patients at 40 sites in the USA. Along with a second pivotal Phase III trial that is on track to begin in the company's fiscal fourth quarter, ending on March 31, 2008, this safety study is intended to support a New Drug Application expected to be filed with the US Food and Drug Administration in 2009.

Vilazodone has a novel dual mechanism of action, acting as both a potent selective serotonin-reuptake inhibitor and as a 5-HT1A partial agonist. Clinical Data is at the same time developing a pharmacogenetic test that would help determine the likelihood that a patient will respond favorably to the drug. Company chief executive Drew Fromkin said: "we are encouraged by the results of our recently-completed pivotal study of vilazodone, which suggests that it has important benefits as a stand-alone compound for patients with depression."