Support Coming in for Female Viagra

Flibanserin is the name of a drug made by a Raleigh-based pharmaceutical company called Sprout.

If it gains approval of the US Food and Drug Administration (FDA) as expected, it will become the first FDA-approved drug for treatment of low sexual desire in women. Though it is often referred to as “Female Viagra,” flibanserin’s method of action is completely different from how Viagra and its competitors work.

Viagra treats erectile dysfunction, which is when a man has persistent difficulty achieving or maintaining an erection, regardless of how much he actually desires sex. Erectile dysfunction is usually caused by insufficient blood flow to the penis, and this is precisely what Viagra treats.

Flibanserin, on the other hand, is designed to treat persistently low sex drive in women. These women may or may not have trouble with actual sexual functioning, but they have very little desire for sex. Flibanserin works by increasing brain levels of neurotransmitters dopamine and norepinephrine and reducing levels of the neurotransmitter serotonin. Low libido in women is not physiologically analogous to erectile dysfunction in men, and flibanserin is not taken on an as-needed basis like Viagra, but is taken daily over the long term.

What Is Hypoactive Sexual Desire Disorder?
Hypoactive sexual desire disorder (HSDD), is characterized by lack of sexual fantasies or desires that cause the person who has it to be distressed or have serious interpersonal difficulties. An HSDD diagnosis should first rule out other health issues, such as depression or other medical disorders that can affect sex drive.

It’s important to note that HSDD isn’t just a phenomenon in women. Men can get it too, but flibanserin is designed specifically to treat HSDD in women who have not yet gone through menopause. There is some controversy of the existence of HSDD as a “disorder,” with some critics saying that lack of sexual desire is not necessarily a pathology and some people simply don’t desire sex.

There’s little debate that HSDD is real, however. Dr. Alyse Kelly-Jones, an OB-GYN in Charlotte says that the disorder requires more in the way of treatment than telling women they should “loosen up.” Kelly-Jones says that MRI scans, which are highly detailed images of the brain, show clear differences between the brains of women with HSDD and women without it.

North Carolina Physicians Speak Out in Favor of Flibanserin
Kelly-Jones and Dr. Ashley Tapscott, a urologist in Huntersville, NC, were among the dozens of people who spoke in Washington during recent FDA advisory panel hearings about whether flibanserin should get FDA approval. Both these doctors say that the risk-benefit analysis of flibanserin indicates that approval is appropriate, particularly considering the lack of other options women have for treating HSDD. Though not a strictly apples-to-apples comparison, there are around 20 drugs available to men for treating erection problems, and unless flibanserin gains FDA approval, there are zero options for women with HSDD.

Drawbacks of Trying to Use Hormones to Treat HSDD
The idea of using hormones to address lack of sex drive has been around for a long time. The problem is, nobody has figured out a way to use hormones to get consistent results and maintain a level of safety necessary for widespread use. In both men and women, testosterone levels influence sexual desire, though women have much lower levels of testosterone than men. The FDA approved a drug called Estratest, which contains both estrogen and testosterone, but it is only approved for treatment of hot flashes many women experience due to menopause.

Some double-blind trials with Estratest have shown that the compound does increase sex drive in menopausal women, and there are doctors who will prescribe it “off-label” in hopes their patients will experience a resurgence of sexual desire. But there are worries about women with normal estrogen levels taking a drug like Estratest, so it’s not widely used. Testosterone by itself has also been tried, but results aren’t consistent or predictable, and side effects, such as a deepening voice or increased acne, can be upsetting to women taking it.

Isn’t Wellbutrin Rumored to Increase Sex Drive?

Clinical depression can squash sex drive, and unfortunately, one of the most common side effects of many effective antidepressant medications is that they too tend to lower sex drive. Wellbutrin, however, is an antidepressant that is much less likely to cause negative sexual side effects many people experience with other antidepressants. Whether it actually increases sex drive is a matter of debate.

Early formulations of Wellbutrin were fast-release, and in a very small proportion of users, it caused seizures. This problem was pretty much resolved with a later, slow-release formula. But the drug never regained popularity due to fear of seizures, and the maker of the drug, Burroughs-Wellcome, wasn’t interested in studying it for treating low sexual desire. Some doctors will prescribe Wellbutrin in hopes of reviving depressed patients’ sex drive, however.

Support for Flibanserin Also Comes from Potential Competitors

Drs. Kelly-Jones and Tapscott are just two of many doctors hoping that flibanserin ultimately gets FDA approval. But some support for flibanserin comes from what may seem an unlikely source: a potential competitor. A company called Palatin Technologies is developing a drug called bremelanotide for HSDD, and it works in still another way to address low sexual desire. Bremelanotide would be taken on an as-needed basis, unlike flibanserin, and the company is now in Phase 3 clinical trials for bremelanotide in North America. Palatin cheered the recent FDA advisory committee approval of flibanserin, believing that it bodes well for bremelanotide’s chances of gaining approval. In fact, Palatin stocks spiked after the committee gave the nod to flibanserin.

Conclusion
Many doctors who treat women with HSDD are hopeful about flibanserin gaining FDA approval so they’ll have something to offer patients whose lack of sexual desire causes them personal distress. The FDA still has to go through several steps to formally approve flibanserin, and although the FDA usually goes along with what its advisory panels recommend, they aren’t obligated. If the FDA does approve flibanserin, it will likely be spring of 2016 before it will become available in pharmacies.

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