Boehringer Ingelheim drops female SF drug flibanserin after negative regulatory feedback

Independent German drug major Boehringer Ingelheim has decided to discontinue the development of its investigational compound flibanserin for the treatment of hypoactive sexual desire disorder (HSDD).

A US Food and Drug Administration panel of advisers earlier this year voted unanimously that the benefits of flibanserin do not outweigh side effects, including fatigue, depression and fainting spells and by 10 to one that it did not increase female libido. The thumbs down probably came as no surprise as, ahead of the FDA’s Reproductive Health Drugs Advisory Committee meeting to discuss the New Drug Application for flibanserin 100mg as a treatment for HSDD in pre-menopausal women, the agency’s reviewers had posted documents expressing reservations about the drug’s efficacy as well as side effects (The Pharma Letters June 17 and 21). The agency has subsequently also called for additional data to support the efficacy and safety profile of the drug.

“The decision was not made lightly, considering the advanced stage of development,” said Andreas Barner, chairman of the board of managing directors and responsible for the Corporate Board Division Pharma Research, Development and Medicine. “We remain convinced of the positive benefit-risk ratio of flibanserin for women suffering with HSDD,” he added.