“We are very pleased with this ninth DMC review of our LibiGel Phase III safety study. Based on this latest DMC review, the long term exposure to LibiGel in the safety study, and other considerations, we believe that we have sufficient exposure to establish pre-approval LibiGel safety and conclude the study,” stated Michael Snabes, M.D., Ph.D., the senior vice president of medical affairs for BioSante.
"The LibiGel Phase III safety study conducted by BioSante is the largest testosterone trial of its kind in men or women, and we have accumulated a large amount of safety data over many years. In addition to our careful consideration of information to date, and previous FDA communications, we believe that the LibiGel safety study will provide the FDA with strong evidence that LibiGel is safe for use in menopausal women, and concluding the study at this time will result in significant on-going cost savings to BioSante,” said Stephen M. Simes, BioSante’s president and chief executive officer.
In addition, BioSante is continuing protocol development of the two new LibiGel Phase III efficacy trials, and intends to provide additional trial design information and timing of trial initiation as appropriate. As stated previously, BioSante intends to apply for an FDA Special Protocol Assessment (SPA) agreement prior to initiating the efficacy trials. It is expected that any new efficacy trial will include the same FDA-required efficacy endpoints as prior Phase III efficacy trials: an increase in the number of satisfying sexual events and sexual desire, and decreased distress associated with low desire. The Company targets an FDA SPA agreement by first quarter 2013.
About LibiGelLibiGel is a testosterone gel in Phase III development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). Two Phase III efficacy trials of LibiGel that enrolled 1,172 subjects and a cardiovascular (CV) events and breast cancer study that enrolled 3,656 subjects have been completed. The two completed efficacy trials were double-blind, placebo-controlled trials in surgically menopausal women each for six-months of therapy. In the two completed Phase III efficacy trials, LibiGel performed as predicted based on previous experience with testosterone products for FSD, including an increase in satisfying sexual activity and sexual desire and a decrease in distress. However, the placebo response in the two efficacy trials was greater than expected; and therefore, LibiGel´s results were not shown to be statistically different from placebo. The completed efficacy trials were conducted according to an FDA special protocol assessment (SPA) agreement. BioSante is developing a protocol for two new LibiGel Phase III efficacy trials. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.