Reader Poll: What Do You Think of FDA Decision to Approve Flibanserin?

August 24, 2015

The US Food and Drug Administration (FDA) recently approved flibanserin (Addyi, Sprout Pharmaceuticals), the first-ever drug to treat hypoactive sexual desire disorder (HSDD) in premenopausal women.

An FDA panel recommended the drug for approval in June with an 18-6 vote.

Many of those who voted in favor still raised caution about the drug’s risks and asked the FDA to put in place a strong Risk Evaluation and Mitigation Strategy and a boxed warning about drinking alcohol while taking the drug. The FDA agreed to all of the panel’s requests, and then some.

An FDA official said during the June panel meeting that the agency considers HSDD an “unmet medical need.” In announcing the approval, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said distressed women now have “an approved treatment option.”

Leah Millheiser, MD, director of the female sexual medical program at Stanford University School of Medicine, has previously told Medscape Medical News that "HSDD is a very real problem for women." The condition is caused by an imbalance in neurotransmitters, and that "there is absolutely a need for a drug that's been shown to be safe and effective," she said.

But controversy follows flibanserin, which some have dubbed the "female Viagra." Two letters to the FDA were signed by some 200 researchers, clinicians, and sex therapists urging the agency not to approve the drug because of its potential adverse effects, especially the higher risk for hypotension and syncope if the patient drinks alcohol while taking the drug.

Critics have also questioned a public relations campaign, funded in part by the drug’s manufacturer Sprout Pharmaceuticals, called Even the Score. According to the letters’ signatories, the campaign put the focus of the drug’s approval on gender inequity at the expense of the drug’s risks.