Female Viagra Has Existed For Six Years. So Why Won’t The FDA Approve It?

FILE - In this Friday, Sept. 27, 2013, file photo, a tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, N.C., headquarters. The pill has been twice rejected, but Sprout Phar... FILE - In this Friday, Sept. 27, 2013, file photo, a tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, N.C., headquarters. The pill has been twice rejected, but Sprout Pharmaceuticals said Tuesday, Feb. 17, 2015, it is refiling its application for flibanserin, adding new information requested by the Food and Drug Administration about how the pill affects driving ability. (AP Photo/Allen G. Breed, File) MORE LESS
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Last week, I spent lunch discussing sex with total strangers.

It’s not as titillating as it sounds. The stories I heard were about frustration and sadness, not orgasms and lubricant. The frustration came from medical professionals who want an FDA-regulated product to help the women and partners they treat every day. The sadness came from women who wanted a normal sex life again.

We were talking about Hypoactive Sexual Desire Disorder, which affects 1 in 10 women, and the pending acceptance of flibanserin, a drug that could help treat the disorder. Flibanserin has been described as the female answer to Viagra, the little blue pill that revolutionized treatment for erectile dysfunction following its launch in April 1998.

Back then, Viagra got fast-tracked and was approved within six months. Cindy Whitehead, Sprout Pharmaceuticals’ CEO, has been trying to get flibanserin to be the first FDA-regulated drug for female sexual dysfunction for six years. So what’s the holdup?

Viagra is one of 26 FDA-approved drugs marketed to treat sexual dysfunction in men. Flibanserin would be the first female equivalent—although the science is considerably different. Whereas Viagra helps to open the arteries to increase blood flow in the penis, flibanserin targets key neurotransmitters that impact sexual desire.

“When we were turned down by the FDA the last time, the reason was that they felt that our effect was only modest. Everything comes down to risk-benefit,” Whitehead said. “Modest sounds like minimal but modest is actually meaningful in this condition.”

The company resubmitted the new drug application to the FDA back in February after completing addition studies and trials. They’ve now studied the effects in more than 11,000 women. On June 4, the FDA will hold a public meeting so a panel of experts who advise the agency on “obstetrics, gynecology, and related specialties” can give a recommendation on flibanserin. It will be the third public meeting to discuss the drug.

“We’ve known about [HSDD] medically for almost forty years and yet we still don’t have a treatment,” Whitehead told the table. “We’re confusing a medical treatment for a medical condition with all these other things that are tied up on our own feelings on sexuality.”

The vote on June 4, though non-binding, will likely signal the agency’s position.

With a yes vote, “we will get better and better products,” Dr. Lisa Larkin, the director of the University of Cincinnati’s Health Women’s Center, told me later. “If this isn’t approved, it will shut down the field in terms of research and development.”

Larkin added: “This is a real condition. There should be options for [women].”

Back in 2010, when it was first up for approval, the same panel decided it wasn’t effective enough. To combat a lack of drugs specifically for female desire, the approach has been to simply repurpose drugs originally made for men–and hope for the best. But now, after studying more than 11,000 women, flibanserin has the science to show it targets dopamine and norepinephrine, chemicals associated with sexual excitement. According to the Journal of Sexual Medicine, flibanserin reported a 37 percent increase in desire among its studies’ participants.

Thus far, the studies have focused on heterosexual women in longterm relationships. But if the drug was to go to market, it would give doctors a new tool to use when working with both heterosexual and homosexual women with HSDD.

Bat Sheva Marcus, the clinical director at the Medical Center for Female Sexuality in Manhattan, said low desire affects everyone in the relationship. “It is so painful to not be wanted,” she said. “Sex is about being wanted on the most elemental level.”

Listening to these women’s stories was heartbreaking. Like the more than 11,000 women involved in clinical trials for this little pink pill, Amanda Parrish and Katherine Campbell are in successful long-term relationships. But they want the relationships to be better and the sexual desire just isn’t there. It isn’t fair, especially when, if the dysfunction were to stem from their husbands, it could be easily fixed.

Katherine is a 30-year-old mother of two from Indiana. She is in her sexual prime but hasn’t felt that way for years, since after the birth of her first child. At first, she thought it was because she had recently given birth. But after a year, Katherine and her husband became worried.

“I’m not going through menopause and I’m not comparing myself to a porn star,” she said. “I’m comparing myself to what I used to have. What I used to have is just gone.”

Amanda, a 58-year-old woman from Nashville, is a self-identified Southern Belle. Owning her sexuality and pleasure was a hurdle she had already jumped. But now, in the throes of a wonderful second marriage, she lost her desire.

“Why is it okay to fix erectile dysfunction in a man and that’s perfectly acceptable but it’s not okay to give me my desire back?” Amanda asked, throwing up her hands. “I don’t want to be like I’m 20 again. I want to want.”

And while she was a part of one of the clinical trials, she did. She found her “want” again.

While this drug, this company, these doctors cannot cure all women, its passage is still important for women like Amanda. Women deserve another tool to combat their sexual dysfunction, and doctors deserve another tool in their treatment regimen. The disparity between 26 drugs for male sexual dysfunction and zero for female dysfunction is fundamentally unfair. The sexual discrimination in drug approval runs deep: It took 39 years for Congress to mandate full coverage of birth control, while Viagra received full-mandated coverage after only three months on the market.

The passage of a drug that will help some women could open the doors to the research and development dollars that can explore cures for a loss of desire in women. Normal desire fluctuates, and it’s time women had at least one drug to men’s 26 to help get them their “want” back.

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