ANTARES LAUNCHES STUDY OF DRUG TO TREAT FSD

Antares Pharma announced that its development partner BioSante Pharmaceuticals has initiated a Phase III safety and efficacy trial of Antares' transdermal testosterone gel, LibiGel, for the treatment of female sexual dysfunction (FSD).

The Phase III trial is scheduled to enroll approximately 360 surgically menopausal women in a double-blind, placebo-controlled, six-month trial. It is currently anticipated that the Phase III safety and efficacy trials, plus one year of safety data, are the essential requirements for submission and approval by the FDA of a new drug application (NDA).

Currently there is no FDA-approved treatment for FSD, according to the company, so this product may help address the unmet medical need if approved. According to a study published in The Journal of the American Medical Association, 43 percent of American women experience some degree of impaired sexual function, the company said.

Antares' Advanced Transdermal Delivery (ATD) formulation of testosterone gel is the second such product for women's health to enter Phase III clinical trials. The first product, ATD low-dose estradiol gel formulation called Elestrin, recently received FDA approval for the treatment of vasometer symptoms in hormone replacement therapy and will be marketed by Bradley Pharmaceuticals.