BioSante Pharmaceuticals, Inc announced enrolment of the 2,500th woman in the LibiGel (testosterone gel) phase-III cardiovascular and breast cancer safety study. This important enrolment milestone triggers the first unblinded statistical analysis of cardiovascular events by the independent Data Monitoring Committee (DMC), which coincides with their fourth unblinded review of all adverse events. LibiGel is being developed for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is currently no FDA approved product. BioSante anticipates the submission of a new drug application (NDA) for LibiGel in 2011.
The DMC's unblinded statistical analysis will determine whether the current study enrolment of 2,500 is sufficient to prove statistically the relative safety of LibiGel compared to placebo after an average of 12 months of exposure is reached, or if enrolment will continue. To date, there have been only 14 adjudicated cardiovascular (CV) events, a rate of approximately 0.65 percent, and only seven diagnoses of breast cancer, a rate of approximately 0.32 percent, after approximately 2,300 women-years of exposure in the study. BioSante will remain blinded as to the distribution of the reported safety events between the active and placebo study arms.
If enrolment continues beyond 2,500 women, an additional unblinded statistical analysis will be conducted by the DMC each time a new cardiovascular event is adjudicated. At each of these analyses the trial potentially could be fully enrolled. If enrolment is not completed sooner, enrolment will continue until the study reaches its predetermined maximum of 4,000 women.
"This milestone gives BioSante our first opportunity potentially to declare completion of enrollment in the safety study," stated Michael Snabes, BioSante's senior vice president of medical affairs. "We have had an extremely low number of cardiovascular and breast cancer events to date, as well as three previous favorable DMC recommendations. We expect the study to demonstrate the safety of LibiGel in the treated population, regardless of whether the DMC stops enrolment at 2,500 women or we need to continue enrolment."
LibiGel is a testosterone gel in phase-III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD).
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology.