Boehringer Ingelheim gets negative view from FDA advisory panel for its 'female Viagra' flibanserin; better EU news on Mirapexin

A US Food and Drug Administration's panel of advisers has voted unanimously that the benefits of independent German drug major Boehringer Ingelheim's female sexual dysfunction drug flibanserin do not outweigh side effects, including fatigue, depression and fainting spells.

The thumbs down probably came as no surprise to the company as, ahead of the FDA's Reproductive Health Drugs Advisory Committee meeting last Friday to discuss the New Drug Application for flibanserin 100mg as a treatment for hypoactive sexual desire disorder (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 Letter June 17). The FDA will consider the committee's advice as part of its final assessment of the NDA.

Commenting on the panel decision, one of its members, Paula Hillard, a gynecologist from Stanford University School of Medicine, said: "I am convinced that women's sexual health is important and that many women suffer from sexual dysfunction, but I'm not convinced of a clinically meaningful benefit for this drug."