Will flibanserin ever become the little pink pill?
Credit: Colourbox
There are 24 FDA-approved drugs to treat sexual dysfunction for men. There are zero for women – and the FDA is keeping it that way after it announced on Tuesday that it was rejecting an experimental drug called flibanserin that treats low female sexual desire, reports Reuters.
The FDA did offer a plan to Sprout Pharmaceuticals so the company can eventually get the drug approved, but representatives from women’s advocacy groups like the National Organization for Women, the Center for Health and Gender Equity, Jewish Women International and the National Council of Women’s Organizations are saying that the FDA seems to be holding flibanserin to a higher standard than it does to male drugs, saying, “We see this not only as an important unmet women’s health issue, but an inflection point for the agency to ensure that similar standards are applied for drug approvals in conditions uniquely affecting women.”
Dr. Jed Kaminetsky of Manhattan Sexual Health and Wellness agrees. “There’s a lack of understanding of the problem and the prevalence of the problem,” he tells us. “There is a bit of sexism. People like the idea of sexy women but feel uncomfortable if women are too sexual – not that this drug is going to make women into overly sexual beings, but throughout history, people have been tempted to repress female sexuality. Eleven thousand women have used this drug and the FDA is still asking them to do more safety studies. I’m not sure what the FDA feels they’re protecting people from.” He points out that Viagra was approved much more easily with “less stringent studies and requirements.”
Though flibanserin has been touted as “female Viagra,” Kaminetsky says the way it works is very different. Unlike Viagra, which increases blood flow to the genitals, flibanserin works on the brain. “Blood flow is not the primary issue in women,” he says. “In most women, the more common problem is desire.” Moreover, women need to take flibanserin daily for it to reverse diminished sexual desire, whereas Viagra is “on demand,” as Kaminetsky describes it.
Kaminetsky points out that though flibanserin is for women, keeping it out of the market does not do anybody good. “I can help a man and give him a pill or injection or penile implant, but if his partner says no dice, it’s not going to do him any good,” he says. “It’s important for women and couples and all people. This is a common problem. Forty-three percent of women suffer from some degree of sexual dysfunction.”
