BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today 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. This achievement represents a key positive step toward completing the LibiGel Phase III clinical development program. To date, we have a combined enrollment in our three LibiGel Phase III clinical studies of approximately 4,000 women and we anticipate announcing completion of enrollment in the second efficacy trial very soon," said Joanne Zborowski, BioSante's vice president of clinical development.
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