BioSante Pharmaceuticals, Inc. Announces Positive LibiGel® Phase III Safety Data Review and Decision to Conclude the Safety Study
Published: Sep 04, 2012
LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today that the independent Data Monitoring Committee (DMC) has completed the ninth unblinded review of the LibiGel Phase III cardiovascular events and breast cancer safety study. The independent DMC has recommended that the LibiGel safety study should continue as per the FDA-agreed protocol, without modifications. LibiGel (testosterone gel) is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women.