What is Flibanserin, and Why are they Calling it the “Female Viagra?”

A key advisory committee voted 18-6 back in August to recommend that the American Food and Drug Administration approve Flibanserin, a drug designed to boost the low sexual drive of otherwise healthy women. The drug is being dubbed the “female Viagra,” and its become a hot topic online. The FDA officially approved the drug just weeks later, and will be sold under the brand name Addyi. Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research said in a statement announcing the approval, “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

Although the FDA approved Viagra for men in 1998, and a host of products since then, this is the first time they’ve approved a drug specifically for women’s sexual function, something they previously described as an “unmet medical need.” Brigid Schulte of The Washington Post (republished in The National Post, the FDA already rejected the drug twice, stating that the potential side effects of fainting, nausea, dizziness, sleepiness and low-blood pressure outweighed the drug’s benefits. Even the advisory committee described the drug as having only “moderate” or “marginal” benefit.

Sprout Pharmaceuticals, developers of the drug, took an opportunity at the initial committee meeting to present the results of a series of double-blind clinical trials. The results illustrated that the drug worked better than placebo to boost women’s sexual desire, increased the number of sexually satisfying events and lowered women’s distress at the loss of their libido. After 24 weeks, 46 to 60% of the women in the trials had benefited from the flibanserin treatment.

Flibanserin, first developed as an anti-depressant, works on neurotransmitters in the brain that affect a woman’s libido. Healthy women who possess significantly low sexual desire clinically suffer from a condition called Hypoactive Sexual Desire Disorder (thought to affect between 5.5 million and 8.6 million US women), which until now has been essentially untreatable medically. Several women provided emotional testimony at the committee meeting prior to the vote, describing the condition “as if a switch had gone off,” not understanding why they no longer want to have sex, and finding this particularly distressing.

According to Schulte, FDA officials are concerned about Flibanserin’s interaction with other drugs — particularly with hormonal birth control pills and alcohol — and the potential for Flibanserin to increase accidents, from car accidents to falls and other mishaps.

The BBC calls the treatment of low sexual desire in women “something of a holy grail for so-called Big Pharma.” Sprout, by gaining approval, succeeded where other major pharmaceutical giants have failed. Pfizer and Procter & Gamble have each attempted to develop products treating low sexual desire in women. And a rival, Palatin Technologies, is rumored to have an alternative treatment for HSDD that is in late-stage trials.

Despite the marginal benefit and host of side affects, the drug has many analysts predicting that Sprout is sitting on a potential goldmine, now that medical practitioners have a treatment available for something being more commonly diagnosed. The FDA’s approval of Addyi, however, does come with stringent safety measures, meaning that its usage is unlikely to be as widespread as with male Viagra.

Check out this CNN report on Viagra and the female alternatives that have been tested in the past 15 years:

Jason Quintal | December 2, 2015

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