FDA Agrees: Now Is the Time for Women’s Viagra

EveryDayHealth.com June 2,2015

EveryDayHealth.com June 2,2015

“I’m just not interested in sex anymore.”

“I don’t think about sex.”

“I miss feeling sexual.”

Welcome to my office.

Of all the sexual problems my patients report, the loss of libido is by far the most common. The medical term for lack of lust is hypoactive sexual desire disorder, or HSDD: an absence of sexual thoughts, fantasies, or desire for sexual activity that causes distress or interpersonal difficulties. The last part is really important.

Not every woman who has zero libido cares or is motivated to do something about it. But millions of women do care, either because they find this loss of libido personally distressing or disinterest in sex has sabotaged a relationship or marriage.

It is perfectly normal to not want to have sex with a guy who smells like the zoo and with whom you don’t even want to be in the same room with much less share a bed. It is perfectly normal to not want to have sex if it is excruciatingly painful. But the woman with HSDD loves her partner, and things work just fine physically, but her libido switch is simply in the off position.

What Keeps Libido Strong

The biological cocktail for an intact libido includes not only hormones such as estrogen and testosterone, but also neurotransmitters that determine how often women think about, and desire, sex. While many neurotransmitters make a contribution, the essential ones are dopamine, norepinephrine, and serotonin.

Dopamine is all about desire. It’s dopamine that creates that feeling of “I want sex, I need sex, and I can’t stop thinking about sex.” Serotonin is all about keeping desire under control so you can stop making love long enough to go to work and do the laundry.

It’s all about balance — enough dopamine to want sex, and enough serotonin so we don’t want it all the time.

So essentially, HSDD is a biological problem. Currently, there are no FDA-approved medications to help women who have HSDD.

This week, the FDA is taking another look at flibanserin, a promising drug that has been shown in multiple scientific studies to help women with HSDD, but was turned down by the FDA in the past. Experts have been invited to speak at a public forum to explain why flibanserin should — or should not — get the FDA nod of approval. I will be one of the experts in Washington on June 4th to step up to the mic and explain how flibanserin works on the brain to increase dopamine and decrease serotonin levels. I will also emphasize that flibanserin is not for everyone. Flibanserin will not help, and should not be prescribed for,  the woman who has a dysfunctional relationship, painful intercourse, or a hormonal imbalance.

Approval of this drug has become controversial and in many ways has become a political issue rather than a medical issue. Many “experts” claim that HSDD is not real, but is a made-up condition so pharmaceutical companies can sell drugs. Yes, HSDD, like other female sexual problems is real, and I am offended that 26 drugs have been approved for male sexual health and none for women, other than to alleviate vaginal dryness.

5 Myths About HSDD That We Need to Debunk

Here are the facts to balance out the fiction:

Myth 1: HSDD is not a real medical condition.

There are more than 13,000 medical publications about HSDD dating back to 1977. Not to mention that anyone who has spent time in my office knows how real it is.

Myth 2: It is an exaggeration that there are 26 drugs approved for male sexual health.

Actually, there are 41 if you include generic drugs for men. But 26 is the number of unique medications.

Myth 3: Sexual problems are mostly due to interpersonal, psychological, or cultural/social issues.

Yes, all of those things are important, and a therapist or change of relationship is often the fix. But biology is also key. Science has shown that activity in the brain is different in women who have HSDD. It is clear that an imbalance of neurotransmitters is at fault. No amount of talk therapy is going to correct a biological imbalance.

Myth 4: Flibanserin doesn’t work.

Women receiving flibanserin in clinical trials reported a 53 percent increase in sexual desire, as measured by the Female Sexual Function Index (FSFI). Adjusted for placebo response, there was a 37 percent increase. This was a meaningful response for the women in the trial.

Myth 5: Flibanserin has too many side effects to justify giving it to healthy women.

There were more than 11,000 women in the flibanserin clinical trials, and they reported no serious side effects. Some women experienced fatigue, nausea, or sleepiness. In contrast, there were only 3,000 men in the Viagra trials, they had  serious side effects such as cardiovascular problems, visual changes, and a drop in blood pressure. Not to mention, men get to choose if they want to take a risk and take a drug to enhance sexual desire!

Women’s sexual health problems are real and deserving of research and development of new drugs. Flibanserin will not solve every sexual problems, but it will treat low sexual desire in a meaningful way and make a difference for millions of women. So stay tuned. I am optimistic that the FDA will not allow bad politics to trump good science.

UPDATE: Since this post ran, the advisory committee to the FDA panel voted 18 to 6 to recommend that flibanserin be approved. It was an exciting day speaking before the committee, and I was honored to be part of the process in a very small way. Many experts spoke, and to say the discussion was lively would be an understatement.

The FDA still must gave final approval before the drug will be released, and certain conditions must be met to ensure safety. But this a huge victory for women and a clear indication that the FDA appreciates that there is an unmet need.

PHOTO CREDIT: Meriel Jane Waissman/Getty Images