The Female “Viagra”: Will It Finally Get Approved by the FDA?

Commonly known as the female “Viagra,” flibanserin is a drug that has been designed to improve women’s sexual desire. Targeted for pre-menopausal women with hypoactive sexual desire disorder, this drug works by altering levels of neurotransmitters in the brain. It increases levels of dopamine and norepinephrine, both associated with sexual excitement, and also reduces serotonin, which is associated with sexual inhibition.

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Many studies have shown that flibanserin is effective in improving a women’s desire for sex and also in increasing the number of satisfying sexual events. One randomized control study found that flibanserin increased the number of satisfying sexual events by an average of 2.5 per month whereas women on placebos only had  an average of 1.5 per month. There have also been many positive reports from various women who participated in the drug trial. A 50-year old women stated that she had difficulty having sex with her fiance, but while on flibanserin, she would get excited by simply talking to her fiance on the phone. Many women on the trial described their experience on the drug as a “sexual reawakening.”

If this drug can truly turn around a women’s sex life, why has the FDA failed to approve the drug? Not once, but twice? The FDA claims that the drug only has a modest impact and the benefits do not outweigh the side effects, which are nausea, sleepiness, fatigue, and dizziness. Many women’s health advocates are outraged by the FDA’s decision; they claim that this reveals a clear bias in standards of approving drugs for women versus men. In the past, the FDA has approved drugs for male sexual dysfunction although they were provided with limited research and the drug exhibited more serious side effects than flibanserin. Why is it that the FDA has approved more than 24 different types of drugs for men’s sexual desire and performance, but not a single one for women? Do you think it is being held at a higher standard or a double standard than for drugs designed for men? 

After Sprout Pharmaceuticals appealed the FDA’s decision and advocates met with the FDA to voice their concern for a lack of treatment for women’s sexual health, FDA has agreed to take a look at flibanserin a third time. However, they are asking for more studies to be performed to “maintain the highest vigilance to protect and advance the health of women.” I am not completely convinced that the FDA truly believes that this drug may be beneficial to women’s sexual health or that they believe that hypoactive sexual desire disorder actually exists, but at least this shows that we are making a significant step toward providing pre-menopausal women access to a treatment option that can potentially improve their sexual life and in turn, their overall health and well-being. Hopefully, a third time’s a charm!

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