LibiGel testosterone regulatory update

BioSante will begin 2 additional Phase III trials of LibiGel testosterone to treat hypoactive sexual desire disorder (HSDD) in menopausal women based on analysis of efficacy data, consultation with key opinion leaders and a meeting with FDA. In a conference call, BioSante said it plans to submit a protocol for the trials next quarter. The company will also request an SPA for the trials, which it hopes to start by year end or 1Q13. Top-line data from the Phase III BLOOM-1 and BLOOM-2 trials showed that LibiGel missed the co-primary endpoints of significantly increasing the total number of days with a satisfying sexual event and of significantly increasing mean sexual desire from baseline to 6 months vs. placebo. BioSante said the placebo response observed in the trials were higher than expected (see BioCentury, Dec. 19, 2011).

The company expects to include the same efficacy endpoints - an increase in the number of satisfying sexual events and sexual desire and decreased distress associated with low desire. BioSante said it would also design the trials to minimize the placebo effect in prior trials. BioSante plans to continue the Phase III cardiovascular and breast cancer safety study, with data slated for next half. ...