For Dr. Alyse Kelly-Jones, hardly a day goes by without hearing questions from female patients about lack of sexual desire.
Kelly-Jones, who specializes in treating sexual dysfunction at Charlotte’s Mintview OB/GYN, said there’s little to offer women with “hypoactive sexual desire disorder,” or persistent lack of sexual desire.
That’s why she traveled to Washington June 4 to speak in support of Food and Drug Administration approval for a controversial new drug called flibanserin (flib-ANN-sir-in) – dubbed the “female Viagra.”
Kelly-Jones and Dr. Ashley Tapscott of Carolina Urology Partners in Huntersville were among 39 speakers who testified, both for and against the “little pink pill.”
After the hearing, the FDA advisory committee recommended approval of the drug for premenopausal women, but only with reservations. The panel was concerned about possible side effects, such as dizziness, low blood pressure and fainting, and also about the drug’s potential interaction with alcohol. The FDA usually follows recommendations of its advisory panels.
Flibanserin, made by Raleigh-based Sprout Pharmaceuticals, would be the first drug approved for treatment of female libido. It works by increasing dopamine and norepinephrine and reducing serotonin in the brain.
Twice before, the FDA rejected flibanserin after other advisory committees raised questions about the drug’s safety and effectiveness. With FDA guidance, Sprout Pharmaceuticals provided new data as part of its latest request.
The drug has caused intense debate among health professionals and women’s advocates.
Some say the campaign for flibanserin medicalizes female sexuality, creating a profitable market for a drug to treat a questionable disorder. Unlike Viagra and other erectile dysfunction drugs, flibanserin must be taken daily, raising questions about long-term side effects.
Supporters launched a campaign called “Even the Score” and produced videos spoofing the ubiquitous prime-time TV commercials for ED drugs. More than 20 such drugs have been approved to treat male sexual dysfunction, and advocates say it’s time to approve one for women.
At the hearing, Kelly-Jones described a distressed patient whose lack of sexual desire threatened her marriage. “There’s something broken inside me and I can’t fix it,” the doctor said, recalling her patient’s words.
Hypoactive sexual desire disorder is “very real,” Kelly-Jones said, and requires more treatment than just telling a woman to “loosen up.” She said MRI images show a marked difference between the brains of women with and without the disorder.
Kelly-Jones said the oft-prescribed antidepressant Wellbutrin carries a five times higher risk of causing low blood pressure than flibanserin. “It’s all about a doctor and patient having a discussion about a risk-benefit analysis,” she said in an interview. “This is going to be about a specific set of women. They need a medication to help them regain control over their lives.”