BioSante Pharmaceuticals, a US-based specialty pharmaceutical company developing female sexual health and oncology products, has reported positive safety data in its ongoing, randomized, double-blind, placebo-controlled, multi-center, LibiGel (testosterone gel) Phase III clinical development program.
LibiGel is being developed to treat female sexual dysfunction (FSD), hypoactive sexual desire disorder (HSDD) in menopausal women to be specific, for which there is no FDA approved product.
BioSante plans to submit the LibiGel NDA for a product launch in 2012.
BioSante president and CEO Stephen Simes said the recent favorable Data Monitoring Committee (DMC) recommendation has strengthened the company's belief that LibiGel will be the first product to be approved by the FDA to treat HSDD.
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