BioSante Pharmaceuticals, Inc. achieved positive safety data in its Phase III program for LibiGel (testosterone Gel ) in development for the treatment of female sexual dysfunction (FSD) and hypoactive sexual desire disorder (HSDD) in menopausal women. In the study with 2,869 women enrolled and more than 3,000 women with years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there were 17 adjudicated cardiovascular (CV) events, with a lower than anticipated rate of approximately 0.57%. Eight breast cancers were reported, a rate of approximately 0.27%.

Following its fifth review of all safety data by an independent Data Monitoring Committee (DMC), the Phase III LibiGel safety study will continue per the FDA -agreed protocol , without modifications. BioSante’s plans to submit the LibiGel NDA for a product launch in 2012.

“LibiGel remains the only product in the world in Phase III development for the treatment of HSDD,” said Stephen M. Simes, BioSante’s president and chief executive officer. “We expect to announce completion of enrollment in both Phase III efficacy trials in the near-future. With this most recent favorable DMC recommendation, we continue to believe that LibiGel will be the first product approved by the FDA to treat HSDD, in menopausal women.”