Female Viagra Gets FDA Approval

On August 18, the US Food and Drug Administration granted approval to a new drug called flibanserin, which is expected to be sold under the trade name Addyi.

There has been plenty of media buzz surrounding flibanserin, because it is the first drug designed to increase sexual desire in pre-menopausal women. In fact, it’s the first drug designed to treat sexual dysfunction of any kind in women. Naturally, comparisons are being made between flibanserin and the widely available drugs for erectile dysfunction (ED) in men like Viagra, Cialis, and Levitra.

But flibanserin is in a different class of drugs altogether, and it’s not like Viagra in that you take it as needed before having sex. Flibanserin is a drug that must be taken long term for the effects to become evident, and unlike ED drugs, it doesn’t have anything to do with improving blood circulation to the genitals.

How Does Flibanserin (Addyi) Work?
Flibanserin was developed by a German pharmaceutical firm in the 1990s as an antidepressant. However, it didn’t work very well as an antidepressant. But researchers noticed that some patients in clinical trials reported a higher sex drive, so the company started testing on women with hypoactive sexual desire disorder (HSDD), which is loss of sex drive that isn’t explainable by medications, illness, physical disabilities, or relationship problems.

In 2011, flibanserin was purchased by Sprout Pharmaceuticals, which tried and failed to gain FDA approval twice. The drug acts on brain chemicals dopamine and serotonin – chemicals that influence mood and appetite. Clinical trials found that women taking the drug reported one additional “sexually satisfying” encounter each month compared with those who took a placebo, and they also scored higher on questionnaires about sexual desire.

Why Is “Female Viagra” an Inaccurate Comparison?
While the term “female Viagra” points out the potential significance of the approval of flibanserin, it’s not really a valid comparison. Viagra and other drugs in its class affect mechanics: they allow increased blood flow to the penis in the presence of sexual stimulation. Flibanserin’s effects are in the brain, fine-tuning levels of neurochemicals that in some women cause an increase in sexual desire.

Women with HSDD may or may not have difficulty with sexual stimulation and enjoyment of the act of sex, but their desire for sexual contact in the first place is low. For some women, this isn’t a problem. In fact, HSDD is only diagnosed if a lack of desire causes difficulty in relationships or self-concept. So while “female Viagra” may indicate that flibanserin’s approval is a big deal and a first, medically speaking the comparison is a false analogy.

Is This a Turning Point in Women’s Sexual Health?
Before flibanserin was approved by the FDA, a number of individual women and women’s groups brought attention to the fact that there are many prescription medications approved for making sex better for men, but none available for women. To many women, FDA approval of flibanserin is a turning point, drawing more attention to women’s sexual needs when men’s sexual needs tend to get plenty of attention already.

In reality, however, it’s unlikely that flibanserin will make as big an impact as Viagra did. Viagra is taken as needed and is a straightforward solution to what is now known to usually be a straightforward blood flow issue. Flibanserin is taken long term, and its effects are much more subtle, so it remains to be seen what its impact will be on women’s sexual health.

Controversy Surrounding the Drug and Its Approval
One criticism flibanserin has faced is that it’s designed to increase spontaneous sexual desire, and many people believe that the drug “medicalizes” something that isn’t medical. In other words, many women can get into sexual activity and enjoy it once they get started, but they have trouble getting started. Is this a problem that should be addressed by taking a pill? A lot of people don’t think so.

Some anti-flibanserin advocates believe that taking a pill to increase spontaneous sexual desire removes meaningful choice from the equation and makes women slaves to society’s expectations about sex. Flibanserin supporters, on the other hand, say that many women with HSDD want this drug and believe it to be a good thing, and that those opposed to the drug are robbing women of their agency in making the choice of whether to take it or not.

What Safety Restrictions Did the FDA Impose?
Flibanserin isn’t going to be handed out like Halloween candy. The FDA’s approval was contingent on the drug’s label bearing a “boxed warning” which is the most serious type of FDA statement. It alerts doctors and patients of the biggest known risk of flibanserin, which is its incompatibility with alcohol. Drinking alcohol while taking flibanserin (which, remember, is taken long term, not as-needed), can cause fainting due to dangerously low blood pressure. Furthermore, other medications, including some antifungals, have a similar interaction with flibanserin.

Doctors will only be able to prescribe flibanserin after they complete an online certification test that demonstrates that they understand the drug’s side effects. Pharmacies, too, will have to be certified before dispensing the medication.

What’s Next for Flibanserin (Addyi)?
The drug is expected to become available in the US in October of 2015. Sprout Pharmaceuticals plans to seek approval for the drug in Canada next, and the company has already started the process of seeking approval from Health Canada. The current plan is to file for approval in Canada in the fourth quarter of 2015.

One company cheering the FDA approval of flibanserin is a potential competitor. Palatin Technologies is developing a drug for HSDD called bremelanotide, which is a drug that’s taken on an as-needed basis by pre-menopausal women for low sexual desire. Bremelanotide also works on brain chemistry, specifically as a melanocortin-4 receptor agonist, but it works within 30 to 60 minutes, and wears off after eight hours. Palatin Technologies considers flibanserin’s FDA approval to be a positive sign for approval of their drug, which is currently in Phase III clinical trials.

Conclusion
Whether or not flibanserin is successful as a treatment for HSDD, its approval has opened up the dialog on sexual desire in women and the lack of medications available for treating sexual dysfunction in women compared to those available for me. The drug’s approval could bode well for drugs under development or in clinical trials for treating HSDD as well.

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