Boehringer Ingelheim disappointed with FDA Advisory Committee recommendations on flibanserin NDA for HSDD

The Reproductive Health Drugs Advisory Committee met today to discuss the new drug application (NDA) for flibanserin 100 mg as a treatment for Hypoactive Sexual Desire Disorder (HSDD) in pre-menopausal women. The advisory committee was convened by and makes recommendations to the U.S. Food and Drug Administration (FDA). The FDA will consider the committee's advice as part of its final assessment of the NDA.

“We are disappointed with the advisory committee's recommendations and will work with the FDA to address questions raised by the advisory committee”

The committee recognised the significant unmet medical need for women with HSDD and the lack of approved treatments for this condition. Members of the committee advised that additional data are necessary to further support the efficacy and safety profile of flibanserin and recommended that clinical development of the drug continue.

"We are disappointed with the advisory committee's recommendations and will work with the FDA to address questions raised by the advisory committee," said Christopher Corsico, M.D., M.P.H., U.S. medical director, Boehringer Ingelheim Pharmaceuticals, Inc. "Our ongoing flibanserin clinical trial programme demonstrates our continued commitment to women with HSDD."