Washington Post

BY BRIGID SCHULTE

“It’s clear the drug shows modest improvement. But even modest improvement may be helpful” for a woman who experiences sexual dysfunction. Vivian Lewis, acting chairman of an advisory committee to the FDAAn advisory committee urged the Food and Drug Administration on Thursday to approve the drug known as the first “female Viagra,” moving the controversial medication one step closer to market.The committee voted 18 to 6 to recommend that the FDA approve flibanserin, which is designed to boost the unexplained low sexual desire of otherwise healthy pre-menopausal women. The panel said any approval should be accompanied by conditions to reduce the risk of side effects, which include fainting, nausea and low blood pressure.The FDA isn’t required to follow the recommendations of its advisory committees, but it often does. A final decision is expected by the end of the summer. Currently, there is no approved treatment for lagging female sex drive, which is known as hypoactive sexual desire disorder (HSDD) and affects an estimated 1 in 10 women. The agency has rejected the drug twice in the past six years, saying the risks of side effects and potentially dangerous interactions with alcohol and other drugs outweighed the benefits. Even on Thursday, committee members said the vote was difficult, given that the drug’s benefit was considered modest or marginal.But the panel backed the drug after an afternoon of often tearful testimony from women who experience low sexual desire. Many described their sex drive as turning off, inexplicably, like a light switch.The panel agreed that, with the proper warning labels, consumer and physician education and follow-up studies, the pill should be made available, given the lack of alternatives.”It’s clear the drug shows modest improvement,” said Vivian Lewis, acting chairman of the Bone, Reproductive and Urologic Drugs Advisory Committee. “But even modest improvement may be helpful for someone who has HSDD.”Committee members repeatedly praised the testimony of the women, some of whom were brought to the hearing by Sprout Pharmaceuticals, the drug’s manufacturer. Katherine Campbell, said she and her husband were missing their son’s first birthday because the hearing was so important to them.”I do understand that this is not a miracle drug,” she said. “I know it won’t turn me into a sex addict. But maybe I’ll want to have sex again, even flirt with my husband again. Because right now, my marriage is in complete distress.”After the vote, a broad coalition of women’s health and feminist groups were elated. “It means that women with HSDD will at least have a choice,” said Anita Clayton, chairman of psychiatry and neurobehavioral sciences at the University of Virginia School of Medicine and a consultant to Sprout Pharmaceuticals. “And it also means that other companies will keep searching for more alternatives. If the committee had voted no, we worried that door would have been shut.”Sally Greenberg, executive director of the National Consumers League, hailed the vote as “a huge moment for women’s sexual health, in the way that the [birth control] pill was.”But some panel members who voted against approval said that the data wasn’t good enough, and the benefits weren’t strong enough, to warrant approval, considering the side effects. “I recognize people are suffering,” said committee member Diane Aronson. “I just think they deserve better.”Several women’s groups opposed approval of flibanserin, saying the FDA was right to reject it in 2010 and 2013, and that the vote Thursday was little more than “emotional blackmail” and the result of a “slick marketing campaign” by Sprout.”Today’s vote was a triumph of emotion over science,” said Leonore Tiefer, a psychologist and longtime sex therapist who has been fighting what she calls the “medicalization” of sex.The FDA approved Viagra for men in 1998 and several products since then, but it has not cleared any medications for women’s sexual function. Flibanserin, first developed as an antidepressant, works on neurotransmitters in the brain that affect sexual desire.Sprout Pharmaceuticals presented the results of a series of double-blind clinical trials – more than 11,000 women have been involved in testing the drug – that showed flibanserin worked better than placebo to boost women’s sexual desire, increased the number of sexually satisfying events and lowered women’s distress at the loss of their libido.In their presentation, FDA medical officers raised concerns about the drug’s side effects, particularly fainting and low blood pressure. They’re recommending that the agency consider including warnings against using the drug with alcohol, with certain drugs or while pregnant. The FDA also may consider requiring a patient registry and practitioner or pharmacist certification.Unlike Viagra, which is taken on an as-needed basis, flibanserin is to be taken every day, 100 milligrams, at night.Barbara Gattuso, who testified with both her husband and her daughter, said she has suffered from low sexual desire for 25 years. Her daughter, Vicki, does, too, and Vicki broke down as she explained that her lack of desire was destroying her marriage.Barbara took the drug in a clinical trial. “It was like, whoo! I was attacking my husband in the middle of the night,” she said after the hearing “It worked for me. I had zero side effects. And I am more than excited about this vote. I am elated for all these women who are suffering. Look at all these smiles.”More at washingtonpost.com/ blogs/to-your-health