Men have far more prescription drug options for treating sexual dysfunction than women do.Ever since Viagra was introduced in 1998, people have wondered when a female version of the drug might become available.
Every few years, a news story will appear about a development toward a “Viagra for women” but it never seems to amount to much. A North Carolina pharmaceutical company called Sprout has been pushing hard to change that over the past few years. They purchased a drug called flibanserin from a German company in 2011 and conducted studies with it on women with low sexual desire. The drug showed promise, but the US Food and Drug Administration (FDA) has yet to grant approval.
After allegations of sexism in the FDA and a growing chorus of concern over the lack of drugs available to treat female sexual dysfunction, the agency has agreed to hold a workshop this fall to discuss the issue.
The Planned FDA Workshop
The FDA plans a patient-focused drug development meeting and scientific workshop on female sexual dysfunction on October 27 and 28 at the FDA’s White Oak campus in Silver Spring, Maryland. The first day of the conference, which is scheduled to run from noon to 5 p.m., is devoted to patient input on problems with female sexual interest and how they affect everyday life. Part of the afternoon’s discussion will concern patient views on currently available therapies to treat low female sexual interest.
The second day of the workshop lasts all day, and includes discussion on scientific challenges related to diagnosing the condition of low sexual desire in women for the purposes of clinical trials. Other discussions will concern the validity of patient-reported outcomes in clinical trials studying treatment for women with low sexual desire.
Who’s Behind the Workshop
The FDA has been under pressure recently due to growing awareness of the lack of drugs available for treating sexual desire problems in women. Other than one or two drugs available to treat symptoms of menopause, there aren’t any drugs designed to help women who have low sexual desire.
A coalition called Even the Score has raised awareness of the disparity between the availability of drugs for men with sexual dysfunction (drugs like Viagra, Levitra, and Cialis) and the lack of availability of comparable drugs for women. Even the Score created an online petition and even drummed up support from some members of Congress, who have taken the case directly to the FDA. Even the Score’s website says, “The approval of safe & effective treatments for low desire should be a priority for the FDA.”
Why a Workshop Might Not Help
But no one is expecting sweeping changes from the FDA after October’s workshop. Sally Greenberg, executive director of the National Consumers League, an organization that pushed for more attention from the FDA on the issue, is not terribly optimistic. While she’s glad the FDA is finally taking the issue seriously, she points out that a lot of data has been reviewed by the FDA for many years, and still there are no treatments for sexual dysfunction in women comparable to those available for men.
Greenberg worries that the workshop could end up fostering “more paralysis by analysis” for such medications, despite what she says are better safety profiles than drugs like Viagra, which was fast-tracked by the FDA and approved in only six months. “Viagra was approved without any of these kinds of workshops,” she told The Wall Street Journal.
Is the FDA Sexist?
The FDA says it isn’t sexist. The current FDA Commissioner is a woman, Margaret A. Hamburg, MD, and in fact several of the top posts at the agency are held by women. One of the main arguments used by the FDA against those who claim sexism prevents the availability of drugs for low female sexual desire is that the drugs submitted for that purpose are fundamentally different from the drugs available to men.
Whereas drugs like Viagra are taken on an as-needed basis, the most prominent of the drugs currently seeking FDA approval for treating sexual dysfunction in women are not. Flibanserin is not a drug that a woman would take as needed, but is a drug a woman would have to take daily on a long term basis to see a benefit.
Some pharmaceutical researchers think the FDA makes it harder to get approval for sexual dysfunction drugs for women than for comparable drugs for men.Where Does Flibanserin Stand in Terms of FDA Approval?
Flibanserin has been submitted to the FDA for approval multiple times, and has been denied approval each time so far. Before selling the drug to Sprout, German pharmaceutical company Boehringer Ingelheim had abandoned development of flibanserin after failing to gain FDA approval for its use as an antidepressant and subsequently failing to gain approval for the drug as a treatment for low libido.
Sprout failed to gain FDA approval in 2013 for flibanserin, but in February of 2014, the FDA agreed to reconsider approval. In return, Sprout has to conduct and submit data for three safety studies: one study of whether the drug affects driving ability, a study on whether it interacts with other drugs, and finally a study on how the drug is metabolized in the liver. The company hopes to submit study results to the FDA by the end of 2014. If it does manage to gain FDA approval at that time, the drug could become available in 2015.
Conclusion
Men who experience sexual dysfunction have more options for addressing it than women do. Viagra alone has been taken by tens of millions of men over the past 15 years, and similar drugs that work in the same way (like Levitra and Cialis) enjoy great popularity. Furthermore, if a man finds Viagra doesn’t work as well as expected, he can try one of Viagra’s competitors to determine if one of them works better.
By holding the two-day workshop on female sexual dysfunction in October, the FDA is at least acknowledging the disparity in options for men versus women. Whether it will ultimately result in more options for women, or more “paralysis by analysis” is still up in the air.
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