BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that enrollment of subjects in the second of two pivotal Phase III LibiGel (testosterone gel) safety and efficacy trials has been completed. Enrollment in the first LibiGel efficacy trial was completed in February. 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 achievement for BioSante and a key step toward completing the LibiGel Phase III clinical development program," said Joanne Zborowski, BioSante's vice president of clinical development. "There are more than 1,000 subjects in the efficacy trials and we anticipate announcing top-line efficacy data this fall. In addition, we have over 3,000 subjects enrolled in our LibiGel Phase III safety study," she added.
Phillip B. Donenberg, BioSante's senior vice president of finance & CFO commented, "This key LibiGel achievement, coupled with our successful financing strategy, guarantees a solid timeline for Phase III efficacy data, with sufficient funds to finance our operations and LibiGel clinical development through that data and well into 2012. As a result, we have removed near-term financial risk from BioSante without the need for additional funds."
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