BioSante Pharmaceuticals Completes Enrollment in LibiGel Phase III Safety Study

BioSante Pharmaceuticals, Inc. BPAX, today announced completion of enrollment in its ongoing LibiGel Phase III cardiovascular and breast cancer safety study. LibiGel is in development for the treatment of female sexual dysfunction, specifically, hypoactive sexual desire disorder in menopausal women, for which there is no FDA-approved product. BioSante has been informed by the LibiGel safety study independent Executive Committee regarding the outcome of the sample size analysis that determines the number of subjects to be enrolled in the LibiGel Phase III safety study. The FDA-agreed sample size analysis indicates that enrollment should stop, based on meeting a minimum 90 percent predictive probability of success of the safety study to show the safety of LibiGel at the primary data analysis. As per the protocol, the safety study will continue for 12 months of therapy from the last subject enrolled before the primary analysis will be conducted by BioSante, which will provide the data for BioSante's new drug application submission anticipated to be made in 2012. The study will continue for five years.