BioSante completes FDA required studies of LibiGel
LINCOLNSHIRE, Ill. BioSante Pharmaceuticals has completed validation studies of its new drug LibiGel, which is used for the treatment of female sexual dysfunction, specifically, hypoactive sexual desire disorder, as required by the Food and Drug Administration as part of the clinical development program for the drug.
The validation studies included keeping patient diaries to measure the number of satisfying sexual events and desire. The BioSante inventory of Sexual Events and Desire was able to differentiate between women with HSDD and women without FSD in a highly statistically significant manner in the categories of sexually satisfying events and sexual desire.
The company has started a Phase III trial of the drug and hopes to start another by early 2008. In addition to two Phase III efficacy trials, BioSante will conduct one Phase III cardiovascular safety study. The safety study will be a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months. An application can be filed and reviewed by the FDA, possibly leading to the approval of LibiGel, at that time.