FDA Advisory Committee Votes Against Flibanserin for Hypoactive Sexual Disorder

Emma Hitt, PhD

June 21, 2010

June 21, 2010 — The US Food and Drug Administration's (FDA) Reproductive Health Drugs Advisory Committee voted 10 to 1 on June 18 that flibanserin, 100 mg (Girosa; Boehringer Ingelheim), was not significantly better than placebo for hypoactive sexual desire disorder (HSDD); they also voted unanimously that the benefits did not compensate for its adverse effects.

The committee met on June 17 and 18, 2010. On June 17, they voted unanimously in favor of the 5-day emergency contraceptive ulipristal. On June 18, however, the voting went in the opposite direction, against flibanserin.

Potential adverse effects associated with flibanserin include loss of consciousness and depression and were considered unacceptable given the limited benefit the drug offers.

A clinical trial of flibanserin presented last year in 1378 premenopausal women with HSDD found that after 24 weeks, the frequency of satisfying sexual events increased significantly in women taking flibanserin 100 mg, from 2.8 at baseline to 4.5 at study end, compared with placebo, which was 2.7 at baseline and increased to 3.7 at the study end. Women taking flibanserin also demonstrated improved sexual desire vs placebo as measured by a daily electronic diary and the Female Sexual Function Index desire domain.

Of the women, 15% stopped treatment because of adverse effects, which included dizziness and fatigue.

"[I was] not convinced of the clinical meaningful benefit of flibanserin," said Paula Hillard, MD, a temporary voting member of the panel and chief of the Department of Obstetrics and Gynecology at the Stanford University School of Medicine, in California.

Panelist Bryce B. Reeve, PhD, from the National Cancer Institute, in Bethesda, Maryland, paraphrased other's comments during the meeting when he said that he had "a lot of concerns" about the measurement of both of the primary endpoints in the trial and what they might mean. "They did not show an improvement in sexual desire on the [electronic diary] scale [compared with] placebo," he said.

The manufacturer intended to market flibanserin as a pill for HSDD in premenopausal women. Although the FDA does not have to follow the advice of the advisory panel, the ruling means that approval is now unlikely in the United States unless additional data can be presented supporting the drug's clinical benefit.

"We are disappointed with the advisory committee's recommendations and will work with the FDA to address questions raised by the advisory committee," noted Christopher Corsico, MD, MPH, US medical director, Boehringer Ingelheim Pharmaceuticals, Inc, in a company press release.

Flibanserin is a 5-hydroxytryptophan (HT)(1A) receptor agonist and 5-HT(2A) receptor antagonist and is not as of yet approved in any country. No treatments directed toward HSDD in women are currently approved for use in the United States.

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