BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced that enrollment of subjects in the first of two pivotal Phase III LibiGel (testosterone gel) safety and efficacy trials has been completed. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product. "This is an important milestone for BioSante...
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