Vilazodone efficacious in controlling depression
POSTED June 3, 2009 - 14:17 | POSTED BY Jyoti Pal
Last edited by Harpreet Bhagrath on June 3, 2009 - 15:01
The randomized, double-blind, placebo-controlled trial was launched in the first quarter of 2006. The present clinical trial of 481 patients was the second of two studies in the final stage of testing.
The results pave way for the Newton, Massachusetts based pharmaceutical developer to seek the Food & Drug Administration’s (FDA) approval for the marketing of the drug by the end of the year.
Efficacy of the drug proved
Vilazodone reduced depression on two rating scales among those who were administered the drug vis-à-vis those who took a placebo. Thus, the drug met its most important objective of reducing the symptoms of depression.
Additionally, the drug reportedly preserved the sex drive of the individual.
"In addition, study findings corroborate that effects of vilazodone on sexual function were comparable to placebo, an important finding since many antidepressants have been associated with causing or exacerbating sexual dysfunction," the company said in a statement.
The study, however, could not establish a proprietary lead biomarker which would have made it simple to find out which individuals would be most receptive to the medication.
"Obviously the fact that they were not able get the perceptively designed biomarker validated is a disappointment, but it sounds as though they have a decent drug in terms of efficacy," analyst Andrew Vaino of Roth Capital Partners said.
About Clinical Data Inc.
Clinical Data Inc. is a global biotechnology company in the business of developing targeted therapeutics. The company, through the PGxHealth Division, utilizes its biomarker expertise and intellectual property to develop and commercialize the therapeutics.
The company is also involved in conducting pharmacogenomic tests that identify serious diseases and help predict drug safety, tolerability, and efficacy.
The company’s late-stage compounds include two unique products, vilazodone, its flagship drug for the treatment of depression, and Stedivaze, a potential best-in-class cardiac stress agent. Both these drugs provide potential advantages over currently available treatments and are thus expected to provide tangible benefits for patients and healthcare professionals.
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