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news.BioSante Pharmaceuticals has completed and reached an additional agreement with the FDA under the special protocol assessment process for its LibiGel program in the treatment of female sexual dysfunction, specifically, hypoactive sexual desire disorder in 'naturally' menopausal women.
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Previously, BioSante received a special protocol assessment (SPA) for LibiGel’s use in ‘surgically’ menopausal women.
Stephen Simes, BioSante’s president & CEO, said: “With our two SPAs and meeting minutes received from the FDA, we have a clearly defined, reasonable and feasible LibiGel development path that can lead to the approval of LibiGel to provide potential benefit for an even broader population of menopausal women.”
In addition to the LibiGel Phase III safety and efficacy trials, two of which are in progress, BioSante is enrolling in a Phase III cardiovascular safety study of LibiGel. Pursuant to a written agreement with the FDA, this one safety study will serve as the basis of safety for both surgically and naturally menopausal women.
The safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months.
At the end of the 12 months, BioSante intends to submit a LibiGel new drug application (NDA) for review and possible approval by the FDA. BioSante will continue to follow the women enrolled in the safety study for an additional four years after the NDA submission and possible approval of LibiGel.