Boehringer Ingelheim has decided to discontinue development of its investigational compound flibanserin for the treatment of hypoactive sexual desire disorder in women in the face of opposition from regulators.

The company said it "continues to believe in the value that flibanserin would have for women suffering with HSDD", but notes that "the response of the authorities and the complexity and extent of further questions that would need to be addressed to potentially obtain registration" has led to the decision. Specifically it has been prompted by advisors to the US Food and Drug Administration rejecting the drug on safety and efficacy concerns in June.

The agency's Reproductive Health Drugs Advisory Committee voted 10-1 that flibanserin is not effective in increasing female libido. They also unanimously ruled that its potential side effects, which include loss of consciousness and depression, are not acceptable given the limited benefit the drug offers.

Boehringer chairman Andreas Barner said “the decision was not made lightly, considering the advanced stage of development", adding that "we remain convinced of the positive benefit-risk ratio of flibanserin for women suffering with HSDD”. Michael Sand, the firm's 'global strategic leader' of flibanserin, said the need for a better understanding of HSDD and its possible treatment continues, "and we hope the scientific and medical communities will build on the knowledge that Boehringer Ingelheim’s research has provided".

Boehringer said it will complete its two most advanced clinical studies "to add knowledge for the scientific community and women suffering with HSDD". The resources dedicated to flibanserin will now be re-allocated to other areas, such as stroke prevention, diabetes and oncology, the company added.