BioSante agrees trial design with FDA for LibiGel

The agreement, under the FDA’s special protocol assessment (SPA) process, affirms that the LibiGel Phase III clinical trial design, clinical endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval in the US. Further, it provides assurance that these agreed measures will serve as the basis for regulatory review and the decision by the FDA to approve a new drug application (NDA) for LibiGel.

Stephen Simes, BioSante’s president and CEO, said: “In addition to being a major milestone for BioSante, the SPA is a significant development for the entire female sexual dysfunction (FSD) category. This action by the FDA confirms the FDA’s position that FSD and hypoactive sexual desire disorder are true diagnosable conditions that women experience, with measurable endpoints that can be evaluated and which deserve therapeutic options.”