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Why the Female Viagra Saga is Worth Paying Attention To

With multiple drugs available to combat male sexual dysfunction, many women believe the time has come to approve a drug that helps to relieve female sexual dysfunction.

With multiple drugs available to combat male sexual dysfunction, many women believe the time has come to approve a drug that helps to relieve female sexual dysfunction.

The quest for a so-called ¨female Viagra¨ is once again in the spotlight with the news that the company purporting to have such a drug has submitted a revised application to the U.S. Food and Drug Administration.

The drug in question is flibanserin, and its patent-holder, Sprout Pharmaceuticals, has been engaged in a long-running campaign to win approval for the drug that Sprout says can relieve symptoms of hypoactive sexual desire disorder, or HSDD, the most common form of female sexual dysfunction.

Although the drug is widely referred to as ¨pink Viagra¨ or ¨female Viagra,¨ flibanserin works in an altogether different way than Viagra and the other male impotence drugs now on the market. While the male drugs help support erectile function by increasing blood flow to the penis, the female drug works on brain chemistry to increase women’s desire for sex.

Corrects Chemical Imbalance

According to Sprout, flibanserin is believed to work by correcting an imbalance of brain chemicals known as neurotransmitters. The company explains that the drug accomplishes this goal by increasing levels of dopamine and norepinephrine, both of which are responsible for sexual arousal, while decreasing levels of serotonin, which tends to inhibit sexual desires. ¨In clinical studies, flibanserin was evaluated for its ability to increase the frequency of satisfying sexual events, increase the intensity of sexual desire, and decrease the associated distress women feel from its loss,¨ according to company literature.

Over the last few years, the FDA has twice turned thumbs down on flibanserin. The drug’s developer and original patent-holder, Germany’s Boehringer Ingelheim, submitted a new drug application for flibanserin roughly five years ago. On June 18, 2010, members of FDA’s Reproductive Health Drugs Advisory Committee unanimously recommended against FDA approval of the drug.

Risks Outweigh Benefits

In an explanation of the panel’s rationale for rejecting the drug, the committee’s chairwoman, Julia V. Johnson, M.D., said the positive effects of the drug were ¨not robust enough to justify the risks.¨ Such risks or side effects, according to Dr. Johnson, included dizziness, fatigue, and nausea.¨

On October 8, 2010, Boehringer Ingelheim announced that it was discontinuing its efforts to develop flibanserin as a treatment for HSDD. However, in a press release announcing its decision, the company made clear that it ¨continues to believe in the value that flibanserin would have for women who experience HSDD, a significant and recognized medical condition that impacts the lives of many women around the world.¨

Flibanserin is a proposed drug designed to help relieve hypoactive sexual desire disorder, the most common form of female sexual dysfunction.

Flibanserin is a proposed drug designed to help relieve hypoactive sexual desire disorder, the most common form of female sexual dysfunction.

In 2011, Boehringer Ingelheim sold its patent for flibanserin to North Carolina-based Sprout Pharmaceuticals, a spin-off from Slate Pharmaceuticals that is ¨focused solely on the delivery of a treatment option for the unmet need of women with HSDD.¨

Sprout Submits Application

After further development work on the drug and additional clinical trials designed to better demonstrate its efficacy, Sprout submitted a new drug application for flibanserin in June 2013. In October 2013, an FDA panel once again turned thumbs down on the drug, arguing that the drug’s risks outweighed its benefits.

Undeterred, Sprout appealed the 2013 rejection and in return got more detailed information from the FDA about its areas of concern and what further testing might be done to conceivably win approval for the drug. Specifically, the regulatory agency suggested that Sprout conduct clinical testing to determine (1) how flibanserin interacts with other commonly prescribed medications and (2) whether the drug impairs the driving ability of those who are taking it.

Revised Application

On February 17, 2015, Sprout announced that it had submitted to the FDA a new drug application for flibanserin that was accompanied by detailed reports on the results from the clinical trials FDA had suggested. Sounding a hopeful note, Sprout CEO Cindy Whitehead said, ¨This year, I am optimistic that women and their partners affected by the life impact of HSDD will have their first potential medical solution.¨

In the ongoing controversy about flibanserin and the need for some sort of drug to treat female sexual dysfunction, two main schools of thought seem to have emerged. Allied with Sprout are a number of women’s rights groups, who contend that the failure of the FDA to approve a drug for women smacks of sexism, along with women who suffer from HSDD and desperately want a cure.

Pro-Flibanserin Organizations

Spearheading the campaign to win FDA approval for flibanserin are two relatively new organizations, both of which have their own websites that seek to drum up online support for the drug. These organizations are Even the Score and Women Deserve. Pointing out that the FDA has approved 26 drugs for the treatment of male sexual dysfunction and none for female sexual dysfunction, Even the Score says, ¨It’s clear that there is an unconscious gender bias at the FDA.¨

Sprout Pharmaceuticals, which holds the patent for flibanserin, claims the drug holds the key to firing up the female libido, while others believe the drug's risks outweigh its benefits.

Sprout Pharmaceuticals, which holds the patent for flibanserin, claims the drug holds the key to firing up the female libido, while others believe the drug’s risks outweigh its benefits.

Arrayed against the pro-flibanserin forces are those who decry the increasing medicalization of sex by the pharmaceuticals industry and who insist that flibanserin is a bad drug that should be rejected because its drawbacks outweigh its benefits.

Outspoken Opponent

One of the most outspoken members of the anti-flibanserin forces is sexologist Leonore Tiefer, Ph.D., an associate professor of psychiatry at New York University School of Medicine. Like others among the anti-flibanserin forces, Tiefer feels the push for flibanserin oversimplifies female sexuality and overlooks the fact that waning sexual desire with advancing age isn’t necessarily a bad thing for some men and women.

According to an article posted at NPR.org, Tiefer is particularly troubled by the trend toward medicalization of virtually any real or perceived ailment. Speaking specifically of the arguments for flibanserin, Tiefer said, ¨The misrepresentation that everybody should be having it — needs to have it, wants to have it, has a problem if they don’t have it — is to change, really, what sexuality is into more of a medical thing. I think that’s a terrible direction for knowledge, for understanding, for society.¨

Fugh-Berman Agrees

Echoing some of the same concerns as Tiefer is Adriane Fugh-Berman, M.D., an associate professor in the Department of Pharmacology and Physiology at Georgetown University Medical Center. Of the push for flibanserin, Dr. Fugh-Berman told NPR, ¨There’s really been a move toward medicalizing normal human experience. And while there are certainly some women who have very troublesome symptoms of low libido, it’s not at all clear that medication is a good answer for them.¨

Terry O’Neill, president of the National Organization for Women, expresses some concerns that are fairly typical of those who feel that sexism may be a factor in FDA’s failure to approve a drug to treat female sexual dysfunction. ¨We live in a culture that has historically discounted the importance of sexual pleasure and sexual desire for women. And I fear that it’s that cultural attitude that men’s sexual health is extremely important, but women’s sexual health is not so important. That’s the cultural attitude that I want to be sure the FDA has not, maybe unconsciously, imported into its deliberative process.¨

Don Amerman is a freelance author who writes extensively about a wide array of nutrition and health-related topics.

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+