FDA Panel Backs Approval of 'Female Viagra'

WASHINGTON, DC — Is third time a charm for "female Viagra"? After being rejected twice before, a US Food and Drug Administration (FDA) advisory committee voted today to back approval of flibanserin, which stands to become the first drug approved specifically for boosting female sexual desire.

Despite an 18-6 vote in favor of approval by the members of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, it was not a slam dunk for flibanserin, dubbed the female or "pink Viagra."

The drug's maker, Sprout Pharmaceuticals, was seeking FDA approval of once-daily, 100-milligram (mg) flibanserin for the treatment of hypoactive sexual desire disorder (HSDD) — as defined in the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders — in premenopausal women. Sprout said that up to 7% of premenopausal women have HSDD.

"The benefits are modest, maybe less than modest," said panelist Walid Gellad, MD, MPH, associate professor of medicine at the University of Pittsburgh in Pennsylvania. "That puts it in good company with other approved drugs," said Dr Gellad, drawing laughter. But, he added, "I have serious, serious safety concerns."

He was not alone. Summing up the committee's view, panel chair Vivian Lewis, MD, said that the modest improvement meant that many women would still have the HSDD diagnosis. "However, even a modest improvement may be helpful clinically for someone who has HSDD," said Dr Lewis, professor of obstetrics and gynecology at the University of Rochester in New York.

The slight benefits barely outweighed the risks for most panelists — especially as many acknowledged that once the drug was approved, it would likely be used off-label in a much wider group of women. The committee told the FDA they'd like to see a Risk Evaluation and Mitigation Strategy for flibanserin that required prescribers to certify that they had been educated about the drug's risks and that they had counseled patients as well.

Some committee members urged the FDA to consider a boxed warning against using alcohol while taking flibanserin, while others wanted to see heightened warnings about drug-drug interactions when taking CYP3A4 inhibitors.

No Third Strike?

This was the third time that flibanserin had come before the FDA for approval. It was rejected by the agency after an advisory panel declined to recommend it in 2010. At that time, flibanserin developer Boehringer Ingelheim sold rights to Sprout. After a second rejection, Sprout appealed the decision. Although the agency said more studies were still required, it agreed to a new advisory committee meeting.

New efficacy data from a phase 3 study designed with the FDA's input showed that women had a 0.5 to 1 event per month additional satisfying sexual event (over baseline), and a 0.3 to 0.4 improvement (on a scale of 1.2 to 6) in the Female Sexual Function Index. They also had a mean 0.3 to 0.4 improvement on the Female Sexual Distress Scale (four-point scale) compared with placebo.

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