FDA Approves the First ‘Female Viagra’

Addyi

When it comes to problems in the bedroom, men have long had several pharmaceutical options—but women were typically out of luck. That begins to change today.
The US Food and Drug Administration has now approved the first drug in the United States to treat a low libido in women. Nicknamed the “female Viagra,” flibanserin is said to treat hypoactive sexual desire disorder, or a persistent lack of sexual desire in premenopausal women. (Despite the nickname, the drug functions differently than Viagra—it targets chemicals in the brain rather than increasing blood flow to the genitals.)


The so-called disorder is said to affect nearly 1 in 10 women.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “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.”

The drug itself, however, is controversial. Since 2010 the FDA has twice rejected Flibanserin, most recently in 2013 due to its negative side effects. While proponents of the drug say it could help women who feel they have no other option, critics argue the pharmaceutical industry is trying to solve a perceived problem—that may be far more complicated, or not, in fact, a problem at all—with a quick fix in pill form.

Some doctors, patients, and activists, however, see the imbalance between medical options for men and women as sexist. The FDA has labeled female sexual dysfunction as one of the top disease areas ripe for treatment. Now, Sprout Pharmaceuticals says, there is one.

“For too long, we have wanted to say, ‘Women are so complex, sex is complex.’ Sex is complex whether I am a man or a woman,” says Sprout chief executive Cindy Whitehead. “And so for women that have lost desire that they used to know, causing either personal or interpersonal distress, while all other factors are going well, those are the women for whom this treatment could offer help.”

And yet critics worry that flibanserin may cause more problems than it will help. Some researchers argue that the drug’s side effects, which include drowsiness and nausea, do not outweigh its moderate benefits. Unlike sildenafil (the generic name for Viagra), which men can take in single doses, women are supposed to take a daily dose of flibanserin, potentially putting them at risk for side effects from mixing the drug with normal activities, including drinking alcohol. Others add that the drug has not been proven to be much more effective than a placebo.

“Flibanserin can cause serious harms, including unpredictable hypotension and sudden unconsciousness, and its adverse effects are exacerbated by alcohol, oral contraceptives, antifungals, triptans and many other drugs,” a team of around 200 researchers said in a letter sent to the FDA earlier this year, demanding that the agency reject the drug.

Nonetheless, the FDA voted to approve it, despite citing an increased risk of low blood pressure or loss of consciousness when the drug is mixed with alcohol or certain other drugs. “Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” Woodcock said.

Sprout Pharmaceuticals says it hopes to have the drug ready for prescriptions by mid-October.