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Female Viagra Gets a Key Green Light

Women have far fewer options than men when it comes to treating sexual dysfunction.

Women have far fewer options than men when it comes to treating sexual dysfunction.

If you’re a man suffering from erectile dysfunction, you have many treatment options, including prescription medications like Viagra that have been shown to be highly effective.

But if you’re a woman who has difficulty being in the mood for sex, well, you’re pretty much out of luck pharmacologically. There are currently no FDA-approved drugs for treating low sexual desire in women. However, a drug called flibanserin, having been rejected by the FDA twice, recently received a greenlight from an FDA advisory committee. The 18-6 vote recommended that the FDA approve flibanserin for treating hypoactive sexual desire disorder (HSDD) in pre-menopausal women. That’s not the same as receiving outright FDA approval, but it’s a step beyond where any other prescription medication for increasing sexual desire in women has gone.

Flibanserin’s Rocky Road to FDA Approval

North Carolina pharmaceutical company Sprout Pharmaceuticals bought flibanserin from a German drug company in 2011, after it had already failed to get FDA approval as a treatment for depression and for low libido in women. Sprout’s clinical trial of over 1,000 women reported a doubling of the number of “satisfying sexual events” for women on the drug. However, those taking a placebo also reported an increase in desire, though not as big a boost as the women taking the real drug.

Last year, the FDA demanded more clinical studies on flibanserin, including studies on how it affects driving (because sleepiness can be a side effect), its interaction with other drugs, and how the liver metabolizes the drug. Sprout submitted those study results late last year, and were given the FDA advisory committee approval in June.

How Flibanserin Works
Flibanserin works in a completely different way than drugs like Viagra. Whereas Viagra and its competitors address blood flow to the penis, flibanserin affects the balance of brain chemicals such as serotonin and dopamine. Sexual desire can plummet when these two neurotransmitters are out of balance. Another difference is that while Viagra is taken on an as-needed basis, flibanserin will have to be taken as a daily therapy. So although you may hear of flibanserin referred to as “Viagra for women,” it isn’t strictly true, because it doesn’t work the same way.

What Is It Like to Take Flibanserin?
Amanda Parrish participated in clinical trials for flibanserin and says it really worked for her. Married in 2005, Parrish said that after a few years she lost interest in initiating sex, saying she tried to be asleep before her husband came to bed to avoid intimacy. She says there wasn’t a problem with arousal, and she loved her husband as much as ever. She told Time, “From my neck down, my body responds perfectly. What’s missing is the lack of desire to start. I became an obligatory participant instead of an initiator.”

Parrish says she was hesitant about taking the drug, worried whether it would turn her into a “sex kitten.” But she says her fears were unfounded, because the drug simply “brought me back to where I was.

Supporters Say It’s About Equality
There are flibanserin supporters who say that the FDA’s eagerness to approve drugs for male sexual dysfunction and their lack of approval for counterpart drugs for women indicates a sexist bias. They say there should be just as much research into female sexual functioning as there has been for males. The sexual disorder itself has been the subject of controversy too. In 2013, the Diagnostic and Statistical Manual of Mental Disorders took out HSDD and replaced it with “female sexual interest / arousal disorder” (FSIAD). The prevalence of the disorder, whatever it’s called, has been debated as well, with some studies saying it affects about 10% of women and others saying it affects more than 40%.

Detractors Say Flibanserin Simply Doesn’t Work That Well
Those who are less enthusiastic about flibanserin say their lack of support is because the drug doesn’t work that well. They question the benefit the clinical trials showed compared to the long term nature of the drug. In other words, is it worth it to women to have to take a drug every day in order to enjoy sex somewhat more than they used to? Though the FDA has always been lukewarm toward flibanserin, they insist they’re not pushing some sort of sexist agenda that male sexual satisfaction is more important than female sexual satisfaction. The FDA insists that rushing to approve a drug with underwhelming clinical data would not be responsible.

The FDA insists it isn’t sexist, but hasn’t been wowed by flibanserin’s clinical data.

The FDA insists it isn’t sexist, but hasn’t been wowed by flibanserin’s clinical data.

Is FDA Approval Guaranteed?
While the advisory committee approval of flibanserin is an encouraging sign, and while the FDA usually follows advisory committee recommendations, they’re not obligated to do so. But with the clinical data on driving, liver metabolism, and drug interactions, Sprout has taken a major step toward approval it was unable to take in the past.

Flibanserin must now obtain approval from the FDA’s Center for Drug Evaluation and Research. If the drug undergoes the FDA’s “standard review,” it will be nearly a year before we’ll know whether it’s approved. The FDA does have the ability to run a “priority review” which only takes six months, but it’s doubtful flibanserin will be considered a big enough breakthrough to warrant a fast-track review.

If the drug is ultimately approved by the FDA, it will likely carry side-effect warnings on the box, may only be prescribed by certified doctors, and could require that a patient registry be established so that further safety data can be collected after the drug hits the market under its proposed brand name Addyi. But you probably won’t see it in pharmacies until next summer, assuming it gets FDA approval.

Sprout isn’t the only pharmaceutical company working on treatment for low sexual desire in women. Palatin Technologies, Inc. is developing a drug called bremelanotide that works in yet a different way from Viagra and flibanserin, and that could be taken on an as-needed basis. Originally tested as a sunless tanning pill, bremelanotide didn’t make people tan, but did results in increased sexual arousal in some test subjects. It has been unable to obtain FDA approval too.

eDrugstore.com is dedicated to helping men and women enjoy sexual intimacy. Working with US-licensed pharmacists, we dispense name brand medications like Viagra with unparalleled service and efficiency.

Don Amerman has spent more than three decades in the business of writing and editing. During the last 15 years, his focus has been on freelance writing. For almost all of his writing, He has done all of his own research, both online and off, including telephone and face-to-face interviews where possible. Don Amerman on Google+