BioSante LibiGel Study Design Changes Could Yield Better Results For Sexual Dysfunction

Two more Phase III studies for the hypoactive sexual desire disorder therapy is the firm’s best financial investment, CEO Simes says, because the revised design is expected to eliminate the greater-than-expected placebo response that derailed the previous studies.

BioSante Pharmaceuticals Inc. is doubling down on its investment on LibiGel, its testosterone gel for hypoactive sexual desire disorder in menopausal women, with a decision to conduct two new Phase III trials in the face of the failure of the last two studies.

The firm believes it can design the trials to minimize the greater-than-expected placebo response that thwarted the statistical significance of LibiGel efficacy in two previous studies, President and CEO Stephen...

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