"The DMC once again has recommended that the safety study continue as per the FDA-agreed protocol, without modification as there were no general or specific safety issues based on their unblinded review of adverse events. We are pleased that the low number of CV events to date is consistent with the safety of testosterone in this population," stated Michael Snabes, M.D., Ph.D., the senior vice president of medical affairs for BioSante. "The enrollment of 3,656 subjects was completed in June 2011, and the primary safety analysis will be conducted and reported in the third quarter of 2012. This analysis will allow us to submit the LibiGel new drug application (NDA) in the fourth quarter of 2012, as planned."

Subjects have been enrolled in this study for an average of 15.7 months. More than 2,000 subjects have been enrolled in the study for more than a year and over 770 subjects have been enrolled for more than two years. The periodic reviews by the DMC are based on their mandate in accordance with FDA agreement on protocol-defined study oversight.

"LibiGel remains the only product in the world in Phase III clinical development for the treatment of HSDD," said Stephen M. Simes, BioSante's president & CEO. "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, also referred to as FSD, in menopausal women."

Source: BioSante Pharmaceuticals, Inc.