The FDA Is Finally Paying Attention to Female Sexual Dysfunction

There are currently no FDA-approved treatments for low libido in women.  

Imagine being diagnosed with a disease that plagues millions of other people — and then finding out that there are no FDA-approved drugs to treat it. For women with low libido, this is the unfortunate — and long-ignored — reality. But there’s hope on the horizon: Yesterday, the FDA opened a two-day landmark meeting to address female sexual dysfunction, inviting sufferers to share their struggles and, if they’ve found relief, what worked for them. Today, the meeting continues as medical experts discuss the diagnostic challenges associated with female sexual dysfunction.

"This is a really important time, because the FDA is realizing that women deserve the same sexual rights as men," Dr. Leah Millheiser, director of female sexual medicine at Stanford University, told Yahoo Health. "This is the first time that they’ve really gone after patient perspective. They didn’t want to hear from the researchers or doctors — they wanted to hear from women suffering from the problem.”

In the last year, female sexual dysfunction has received increasing attention as a grossly under-diagnosed and under-treated issue. On Jan. 27, four congresswomen sent a letter to the FDA, pointing out the embarrassing disparity between sexual-dysfunction treatment options for men and women. On Oct. 23, a group of 83 medical professionals urged the FDA to make female sexual dysfunction a priority. Even the Score, a campaign for sexual-health equality, has started a petition to push the problem to the forefront of the FDA’s proceedings.

 “This meeting was long overdue,” said Dr. Mohit Khera, a urologist at the Baylor College of Medicine, who specializes in female sexual dysfunction. “We have made such advances for men — we have 26 drugs [for sexual dysfunction] now available for men.” Yet there are none for low libido in women. That’s partly because male sexual difficulty is usually easy to diagnose: A man either can or can’t get an erection. By contrast, “many people don’t believe that female sexual dysfunction is real, because it’s more subjective,” he said.

Similarly, it can be difficult to gauge whether drugs for female sexual dysfunction actually make a meaningful impact, since the condition is multifactorial — not, say, just an issue of becoming erect. “The problem is not just about brain chemistry. It’s not just about hormones,” said Millheiser. “It’s about everything happening in a woman’s life.”

Despite this lack of attention, the problem is vast: By some estimates, nearly half — 43 percent — of women in the U.S. suffer from sexual dysfunction, with the most common diagnosis being hypoactive sexual desire disorder (HSDD), or low libido. Leaving this condition untreated while addressing men’s sexual difficulties is a recipe for dissatisfaction, said Khera. “What is the point of improving a man’s sex drive and ability to get an erection if you’re not going to increase his partner’s libido?” he asked. “All you’re doing is creating problems. It’s almost a setup for conflict.” In fact, in a 2011 study in the Archives of Sexual Behavior, men who reported higher desire than their significant other tended to feel dissatisfied in their long-term relationships.

The resulting disruption among couples may partly explain one of the hallmarks of female sexual dysfunction: feeling disturbed by the problem. “If she’s not bothered by the fact that she has a low libido, she does not have a disorder,” Khera told Yahoo Health. “She has to be bothered by the condition — that’s a very important distinction.”

And when a woman is disturbed by her sexual difficulties, the effects can be far-reaching. As Michelle King Robson, founder of EmpowHER and a former sexual-dysfunction sufferer, said at the meeting yesterday, “[Sexual dysfunction] ruins the quality of women’s lives. It impacts our ability to be productive contributors to the U.S. economy. It harms men and families when it destroys relationships and marriages.”

Although there is a drug, Intrinsa, available in Europe to treat HSDD, the FDA rejected this testosterone-based treatment due to safety concerns. The result: The U.S. is lagging behind. In Europe, “they take this condition very seriously,” said Khera. “There have been numerous studies looking at this issue — most of them have been out of the U.S. in Australia and Europe.”

As of now, American women with sexual pain — one facet of dysfunction — can be treated with prescription vaginal estrogen creams, but in the case of low libido, doctors have been forced to resort to off-label treatments. “We use testosterone quite commonly,” said Khera. “Satisfaction can be quite high, but there are side effects with testosterone. There’s acne. Facial hair. And many women aren’t comfortable taking hormones.” 

Another off-label option: Wellbutrin, an antidepressant that boosts dopamine levels. But, again, there are side effects — headache, nausea, and constipation, among others — that tend to deter women from taking the drug. Plus, “many women don’t want to take an antidepressant, just because of the stigma,” Khera told Yahoo Health. “Our current therapies are not sufficient.” As Vicki, 39, a woman with HSDD, said at the FDA meeting yesterday, “Women like me that feel this way need a solution. We deserve to feel our sexual desire again.”  

There is a promising treatment in the pipeline: flibanserin, a non-hormonal drug for HSDD in pre-menopausal women. It works by increasing levels of dopamine and norepinephrine, which help build sexual excitement, and suppressing serotonin, which causes sexual inhibition. “They’ve studied over 11,000 women, and it’s shown to be very effective,” said Khera. Last year, however, the FDA failed to approve the drug a second time, citing concerns over side effects like sleepiness.

"If you say to a woman, ‘I can give you one or two sexually satisfying events per month. Is that enough to warrant the side effect of feeling drowsy in the morning?’ most women will say, ‘Absolutely," said Millheiser. "It’s impacting her relationships and her sexual self-esteem, her overall self-esteem, her relationship with her friends, family, her performance at work." 

Still, the FDA “wanted further studies to be done,” Khera said. “It’s surprising because other drugs for men that have worse side effects were still approved.” The drug’s manufacturer, Sprout Pharmaceuticals, has appealed the FDA’s decision. 

This week’s meeting just might be the push necessary to get flibanserin approved, according to Khera. “This meeting is a big step,” he said. “I’m really happy to see that it’s happening. We need more therapies. We have to have something on-label for women.” Or as Susan Scanlan, chair of Even the Score, said in a statement, “The FDA’s public workshop represents a historic moment in the fight for gender equity in sexual health…We hope that the outcome of this process is approval by the FDA of safe and effective treatments for women’s most common sexual complaint.”