Sexual dysfunction is no respecter of gender, affecting both males and females alike. However, judging solely by the number of medications approved for the treatment of sexual dysfunction, one might be forgiven for assuming that it is largely confined to men.
Rankled by the continuing lack of any effective drug for the treatment of female sexual dysfunction, a number of women’s health and rights groups recently launched Eventhescore.org, a campaign dedicated to pressing for change. Specifically, Eventhescore and its supporters want the U.S. Food and Drug Administration to approve a medication to treat hypoactive sexual desire disorder, or HSDD, the most common form of female sexual dysfunction.
FDA Workshop
In late October 2014, the FDA held a ground-breaking, two-day public workshop designed to let women voice their concerns about the apparent gender-based inequity in sexual dysfunction treatment. Women who spoke at the landmark meeting complained that while the drug regulatory agency had approved more than 20 medications to treat male sexual dysfunction over the past 16 years, not a single comparable drug for women has got the nod.
While some health professionals — women among them — have questioned whether the lack of sexual desire is something that can be treated with a pill, women advocates of action point to the experimental medication known as flibanserin as a possible step in the right direction.
2 Bids for Approval Nixed
The FDA has twice rejected petitions for approval to market flibanserin, a product produced by North Carolina-based Sprout Pharmaceuticals. The drug company expects early next year to once again ask the regulatory agency to give the green light to the drug that Sprout claims can fire up the female libido.
One of the more outspoken naysayers is Leonore Tiefer, a New York-based clinical psychologist and therapist concerned by the increasing medicalization of female sexuality. Speaking at the recent FDA workshop, she urged the FDA to resist pressure from Eventhescore.
‘Flagrant Marketing Tactic’
Of Eventhescore.org itself, Tiefer characterized the initiative as ¨a flagrant marketing tactic disguised as a pro-woman campaign.¨ She went on to lament the continuing push for a drug to counteract female sexual dysfunction, saying, ¨It’s very distressing to hear we are committed to developing a drug, when in fact we can’t even decide what it’s for. This is not the way to do science.¨
The vast majority of the women testifying at the FDA workshop were able to protect their privacy by giving only their first names. Most spoke of how they had either lost their interest in sex altogether or had experienced a sharp decline in feelings of sexual desire. In some cases, the women linked this waning of sexual desire to childbirth, menopause, or a hysterectomy. In many cases, they could find no triggering event at all.
Part of the challenge facing the pharmaceutical industry has to do with the essential differences between the symptoms of impotence in men and a lack of sexual desire among women. The former can be addressed by optimizing blood flow to the penis, whereas female sexual dysfunction seems a bit more difficult to dissect, much less to cure.
Women Grow Impatient
However, describing the complexity of treating female sexual dysfunction is no longer an acceptable excuse for inaction, according to Susan Scanlan, chair of Eventhescore.org and head of the National Council of Women’s Organizations. ¨We’re tired of hearing, ‘It’s complex.’ Men are complex, too, and there is no shortage of drugs for them.¨
Many women suffering from HSDD are pinning their hopes on flibanserin, which works on brain chemistry to increase sexual desire in women. Although it has sometimes been referred to as ¨female Viagra,” flibanserin works in an altogether different way to stoke the female libido.
How Flibanserin Works
Specifically, the drug increases the brain levels of dopamine and norepinephrine, both of which are neurotransmitters believed to play a key role in female sexual desire. At the same time, flibanserin reduces brain levels of serotonin, another neurotransmitter but one that is widely associated with a lowering of sexual desire.
By contrast, PDE5 inhibitors, the most popular of the drugs for treating male sexual dysfunction, focus on strengthening blood flow to the penis, which is essential for the achievement and maintenance of an erection.
These pills for men accomplish that goal by temporarily blocking the effects of the phosphodiesterase-5 enzyme, which can make it more difficult or even impossible to get and keep an erection. One of the PDE5 enzyme’s primary goals is breaking down a compound known as cyclic guanosine monophosphate, or cGMP, which relaxes the smooth muscles lining blood vessels that supply the penis. In doing so, cGMP promotes penile blood flow and facilitates erection. By temporarily disabling the PDE5 enzyme, cGMP is free to do its thing without interference.
Benefit-Risk Analysis
In twice rejecting petitions for marketing approval of flibanserin, the FDA drug review panel seemed to be saying that the drug’s benefits were not enough to outweigh its risks. However, the agency has agreed to reconsider Sprout’s petition to market the drug once again in early 2015. It has asked the pharmaceutical company to do additional testing to determine whether flibanserin interacted adversely with other drugs and/or impaired the driving ability of those taking it. The agency also wants to know more about how the liver metabolizes the drug.
Complicating the approval process has been a radical change in how the American Psychiatric Association defines female sexual dysfunction. Last year the professional organization removed hypoactive sexual desire disorder from its diagnostic manual, replacing it with ¨female sexual interest/arousal disorder,¨ also known as FSAID [sic].
By lumping together different aspects of female sexual dysfunction, the FSAID definition now creates an even higher hurdle for a drug to clear in order to win approval as a treatment.
FSAID Criticized
Johns Hopkins clinical psychologist Leonard DeRogatis, a lead researcher in flibanserin’s most recently completed clinical trial, told the ¨Philadelphia Inquirer¨ that he has ¨problems with FSAID on so many levels.¨ He said the new APA definition ¨is a nondiagnostic entity and just got slapped together.¨
Flibanserin was originally researched as an antidepressant by its developer, German pharmaceutical company Boehringer-Ingelheim. The family-owned drug company later submitted a petition for FDA approval to market the drug as a treatment for HSDD. Not long after an FDA panel rejected the petition in June 2010, Boehringer-Ingelheim sold the rights to flibanserin to Sprout Pharmaceuticals, which is based in Raleigh, North Carolina.
Sprout mounted a second bid to win approval for flibanserin, which was rejected by the FDA in 2013. In all, the drug has been tested in more than 11,000 women, not counting ongoing tests to meet the FDA’s latest demands. Sprout is hoping that the third petition for flibanserin’s approval will prove to be the charm.
Don Amerman is a freelance author who writes extensively about a wide array of nutrition and health-related topics.
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