Here’s an intriguing statistic: sexual dysfunction is more prevalent in women, with 43% of women experiencing it compared to 31% of men.
The US Food and Drug Administration (FDA) has approved 24 drugs for treating male sexual dysfunction, but for women it has approved none. Viagra has been around since 1998, and men have their choice of Viagra as well as other drugs in the same class, plus drugs like testosterone supplements for men with low testosterone levels. Viagra is so popular that it’s the most counterfeited drug ever, yet when women have problems with sexual functioning, they have no lifestyle drugs to help. There is no single reason to explain this discrepancy, but rather a confluence of several factors.
Differences Between Male and Female Sexual Performance
Women can participate in sexual activity even if they have no desire for it. Men, on the other hand, may have plenty of desire, but problems with the “plumbing” of the genitals can prevent them from engaging in sex. In other words, with men, the situation is more straightforward: if blood flow to the penis is inadequate for achieving an erection, he can most likely take drugs that address this issue. The lack of drugs available to address female sexual dysfunction has led some women’s health advocates to allege that since women can still participate in sex without desire, the medical profession doesn’t take that lack of desire seriously.
Women can experience sexual dysfunction related to blood flow, and as with men, these problems are more prevalent in women with certain health conditions, like diabetes. However, women who are otherwise healthy may experience lack of sexual desire that seriously affects their quality of life, and many women and women’s health experts are frustrated with women’s lack of medical treatments. Moreover several drugs hoping to become the “female Viagra” have hit roadblocks on the way to FDA approval.
Early Contenders for the “Female Viagra” Title
One of the handful of drugs developed to address low sex drive in women was a gel called LibiGel made by pharmaceutical company BioSante. However, FDA trials of the drug in 2011 showed that the drug was not significantly more effective than a placebo. Another drug called Bremelanotide was a non-hormonal drug administered via nasal inhaler. Bremelanotide doesn’t act on the vascular system, but activates melanocortin receptors in the brain, helping to increase sexual drive. While this drug worked for some women in trials, the side effects, which included spikes on blood pressure as well as vomiting, took it out of contention. Researchers are now working on a version of Bremelanotide delivered by injection, and hope to test it in Europe, but it’s still a long way from approval in the US.
A Dutch company called Emotional Brain has been working on two drugs, Lybrido and Lybridos, both of which affect the balance of serotonin and dopamine in the brain, and which are coated in a testosterone compound that supposedly gives sex drive a quick, temporary boost. Both drugs have undergone Phase 2 clinical studies, and Lybrido is further along the road to Phase 3 trials, but submission to the FDA for approval won’t happen until Phase 3 results are complete, and there’s no guarantee the drug will be approved then.
Could Flibanserin Be First?
A drug called Flibanserin, originally developed by Boehringer Ingelheim, is currently being developed by Sprout Pharmaceuticals, and has presented phase 3 results to the FDA. After being rejected by the FDA in 2010, Sprout resubmitted its application late in 2013, including results from 14 new clinical studies on more than 3,000 women. A total of more than 11,000 women have participated in clinical trials of Flibanserin, but the FDA hasn’t been impressed. Late in 2013, the FDA again rejected the drug, contending that the effects were only “moderate.” Sprout and some women’s health advocates objected, saying that “moderate” effectiveness could still help a lot of women. The company plans to resubmit its application to the FDA later in 2014.
So What’s The Problem?
Anita H. Clayton, MD, professor of obstetrics and gynecology at the University of Virginia Medical School says that the problem is that approval of drugs for female sexual dysfunction are based on standards of male sexuality, rather than establishing a different baseline for female sexuality and measuring improvement from there.
Polls have shown that nearly two-thirds of American women believe that there is a double standard when it comes to male vs. female sexual function, with researchers placing a greater emphasis on the importance of men’s sexual satisfaction than women’s. However, the FDA (currently helmed by a woman) denies this, and says it bases its decisions on clinical effectiveness. Unless the mindset at the top of the FDA changes, America could wait several more years before having a prescription medication to address sexual dysfunction in women.
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