BioSante reported that with 2,869 women enrolled and over 3,000 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 17 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.57 percent. There have been eight breast cancers reported, a rate of approximately 0.27 percent.
Therefore, the Phase III LibiGel (testosterone gel) safety study will continue as per the FDA-agreed protocol, without modifications including continued enrollment of new subjects. This was the recommendation of the independent Data Monitoring Committee (DMC) based on its 5th unblinded review of all study safety data. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA approved product.
“Once again, the DMC 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. In addition, 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. “Once the DMC determines that there are enough subjects enrolled for statistical significance, enrollment of new subjects will be complete. The protocol allows up to 4,000 women to be enrolled, however, the DMC may recommend completion of enrollment at any time between the current enrollment and the 4,000 women maximum.”
Subjects have been enrolled in this study for an average of 12.5 months. More than 1,000 subjects have been enrolled in the study for more than a year and over 550 subjects 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. BioSante’s objective is to submit the LibiGel NDA for a product launch in 2012.
“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. “We expect to announce completion of enrollment in both Phase III efficacy trials in the near-future,” Mr. Simes continued. “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,”