BioSante gains new FDA SPA for Libigel

US firm BioSante Pharmaceuticals has reached an additional agreement with the US Food and Drug Administration under the Special Protocol Assessment process for its LibiGel (transdermal testosterone gel) program in the treatment of female sexual dysfunction, specifically, hypoactive sexual desire disorder in naturally menopausal women. Previously, BioSante received an SPA for LibiGel's use in surgically menopausal women.

In addition to the LibiGel Phase III safety and efficacy trials, two of which are in progress, the firm is enrolling for a Phase III cardiovascular safety study. Pursuant to a written agreement with the FDA, this study will serve as the basis of safety for both surgically- and naturally- menopausal women. The safety trial is a randomized, double-blind, placebo-controlled, multicenter, cardiovascular-events driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months. At the end of the period, BioSante intends to submit a New Drug Application for the product, but will continue to follow the women enrolled in the safety study for an additional four years.

Treatment with LibiGel in a Phase II clinical trial significantly increased the number of satisfying sexual events by 238% versus baseline (p<0.0001); this increase was also significant versus placebo (p<0.05). In the study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving treatment.