Schizophrenia

[genisi]

Clinical Data Says Antidepressant Preserves Sex Drive

http://www.bloomberg.com/apps/news?pid=20601103&sid=aY_7uIjB4X_Q

By Julie Ziegler

June 2 (Bloomberg) -- Clinical Data Inc.’s flagship antidepressant is effective without reducing sexual drive, according to a study that paves the way for the company to seek U.S. approval for the medication by year’s end.

The drug, vilazodone, reduced depression on two rating scales among those who took it compared with a placebo, upholding earlier results, the Newton, Massachusetts-based pharmaceutical developer said today. The study failed to identify a so-called biomarker that would make it easier to determine which individuals would be most receptive to the medication, the company said.

Sexual dysfunction is a commonly reported side effect of treatment with antidepressants. Several popular drugs for depression decrease desire or sexual enjoyment, causing patients to stop taking the medication, according to researchers. If approved by regulators, vilazodone may compete with treatments including Eli Lilly & Co.’s Prozac, Pfizer Inc.’s Zoloft and GlaxoSmithKline Plc’s Paxil.

The study “validates, as a company, our drug development capabilities,” Chief Executive Officer Drew Fromkin said in an interview. Almost 21 million Americans a year suffer from depressive disorders, including major depression, according to the National Institute of Mental Health.

The failure to identify the biomarker “is an issue and will be an issue in terms of commercialization going forward,” said Andrew Vaino, an analyst at Roth Capital Partners LLC based in Newport Beach, California. Vilazodone’s success will depend on the magnitude of the effectiveness shown in the trial, Vaino said, adding that detailed results have yet to be released.

The clinical trial of 481 patients was the second of two studies in the final stage of testing normally needed for U.S. regulators to consider approving a drug.