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Healthy Aging

Flibanserin Studies Continue: Will It Ever Become the Female Viagra?

By Sheryl Kraft

Created: 02/25/2014
Last Updated: 02/25/2014

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If you're a woman experiencing a diminishing libido, you might be waiting anxiously for what men have enjoyed since 1998: your own version of Viagra.

For men, the little blue pill—Viagra (or other brands of erectile dysfunction medicine)—may be a familiar part of their medical arsenal, but for women, their own pink pill is still just a dream.

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reports sexual dysfunction being common in women, with "a community prevalence of 30-50%." from 2002 states that sexual desire can be affected by certain female reproductive life events and experiences, including menstrual cycle, hormonal contraceptives, pregnancy (particularly postpartum states and lactation), hysterectomy and both peri- and post-menopause.

And since most of us experience—singly or in combination—one or many of these events, is it any wonder that so many adult women in the United States have female hypoactive sexual desire disorder (also known as HSDD)? Basically, this means that a woman experiences a persistent or recurrent lack of thoughts about sex, sexual fantasies and/or desire for sexual activity.

A lagging libido can impact not just how you feel physically but also emotionally, affecting your quality of life. That's the key element in diagnosing HSDD. If your lack of interest in sex causes you distress or interpersonal difficulty, then you may have HSDD. If you're not interested in sex but you're comfortable with that and it's not affecting your quality of life, then you don't have HSDD.

For those who are concerned and want a pill to fix it, where is the female Viagra?

Things were moving right along. Until they weren't.

Flibanserin was being studied as a nonhormonal treatment for premenopausal women with low sexual desire. But it has had a rough journey—and the voyage is not yet complete.

Developed by the pharmaceutical company Boehringer Ingelheim, flibanserin has been through many vigorous clinical trials. But when the U.S. Food & Drug Administration (FDA) halted approval of the drug in 2010, asking for more research, Boehringer Ingelheim dropped its developmental efforts. Later, the rights to it were transferred to Sprout Pharmaceuticals, which is currently pursuing appeal and approval of the drug.

The drug works by increasing levels of the neurotransmitters dopamine and noradrenaline, while lowering levels of serotonin. It needs to be taken once a day, every day, and can cause side effects like fatigue, sleepiness, dizziness or nausea.

According to an article on , Sprout reported they resubmitted an application in 2013 that included 14 new clinical studies that showed data on more than 3,000 patients. More than 11,000 people have thus far participated in clinical trials for the drug, but the FDA still hasn't approved it, characterizing the drug as having a modest effect. Sprout plans to resubmit the drug application to the FDA later this year.

Two earlier North American flibanserin studies showed a statistically significant difference between flibanserin and placebo for "satisfying sexual events," but both of those trials failed to demonstrate a statistically significant improvement in sexual desire. Therefore, neither study proved that flibanserin met the criteria for successfully treating HSDD.

There are currently a few other drugs that are in the works to treat women's low sexual desire, but none have completed the trials necessary to be considered by the FDA.

A quick search around the Web, shows that there are several medications, a whole lot of non-pharmaceutical alternatives, available to treat male sexual dysfunction. Mayo Clinic lists Viagra, Cyalis and Levitra. WebMD lists five, adding Staxyn and Stendra to the list. And then there are testosterone hormones and herbal supplements.

In a , Jan Shifren, director of the Midlife boutron program at Massachusetts General Hospital, says: "The principal problem for men is plumbing. They don't have low libido." Women, she says, don't have a problem with anatomy, but have a much more complex problem. When it comes to women, says Shifren, "I suspect there will never be a simple pill."

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Next week, I'll bring you some information on women and sexuality from an interesting and informative lecture I attended during my recent visit to the in Tucson, Arizona. As hesitant as I was to come in from the lovely warmth and sunshine, the discussion "Let's Talk About Sex (For Women Only)," led by registered nurse and certified menopause practitioner Sheryl Brooks, gave me a lot to think about on the subject of women and libido.

Comments

The side effects of this drug are a real turn off. And honestly I don't know a lot of women who really care enough to go through all this.

It'll be interesting to see when (and if) the drug comes out what the reception from women will be.

This is useful information for women over 50. I'm sure it was hard to come in out of the warm, fresh air and was so glad it was well worth it!

Yes, Cathy, coming in from the fresh air has its advantages when there's something to be learned!

Why don't men realize that all their Viagra and Cialis is just going to go to waste if they don't spend the money to come up with similar products for women??

They're trying, it just is taking a bit longer than anticipated, I suppose.

I'm just not a fan of ingesting medications that work on dopamine, serotonin etc. Messing with those levels could have long lasting ramifications. I definitely think that as hormones wane, drive wanes, too. That's how nature made us. What's to say that's wrong, for men or women? I would do everything possible to maintain a good sex life short of taking meds.

I totally understand your feelings, Carol. Thanks for sharing. And in my next post, we'll discuss drug-free options.

Thanks for providing these updates, Sheryl. Very interesting developments, and I look forward to your next post on this issue.

And thanks for reading and commenting, Helene. Stay tuned.

I'm looking forward to hearing what you learned at the spa lecture!

Stay tuned - coming soon!

I have never heard of this drug but all these drugs that mess with the body's chemistry make me wonder what the long-term effects might be, and how they might influence the progeny of the takers.

Interesting post, Sheryl. I'm looking forward to learning more.

Thanks for all this solid information. Us midlife women need to be be armed with information, we've learned that we are in charge of our own health.

Always hard to follow because you only hear snippets on the news~

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I think it would be worth a try anyways.

I appreciate your blog post. The problem with calling flibanserine the female viagra is that viagra is not for libido, it's for erectile dysfunction (and men DO get low libido, but viagra doesn't work for that).
Flibanserine showed no uptick in female libido, which is what it's being marketed for. Clinical trials did show that it reacts in the body like 4 alcoholic drinks. Women have to take it at night due to the side effect of sleepiness. Combining this drug WITH alcohol led to more than twice the accidents in women who took the drug over those who were in the placebo group. 21% also reported dizziness, low blood pressure, fainting, and extreme fatigue.
Low libido in women is so complex. We all have sex for different reasons. Really getting underneath WHY hormones are out of whack, fixing adrenal fatigue, and getting the right diet for blood sugar balance is essential. Additionally, emotional and mental beliefs are so important in the workings of our sexual desire. The higher our stress, the lower our desire. If our hormones are imbalanced and our stress is high and we are holding onto emotional hurts, we will not have desire. Those things need to be addressed and this pill won't take care of any of them.

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