“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.
BioSante Pharmaceuticals Announces Positive LibiGel® Phase III Safety Data Review And Decision To Conclude The Safety Study
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