US regulators have approved flibanserin, better known as “female Viagra,” the world’s first commercial drug to boost sexual desire in women.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, M.D. and director of the Food and Drug Administration (FDA) Center for Drug Evaluation and Research. The drug, to be sold under the name “Addyi” by Sprout Pharmaceuticals, is specifically for pre-menopausal women suffering from hypoactive sexual desire disorder (HSDD), or low sexual desire that is not the result of another medical or psychiatric condition.
While some proponents call the approval a win for gender equality, flibanserin, which has been rejected by the FDA two times before, has some serious side effects, including dizziness, drowsiness, and fainting, and falling blood pressure. Between 10% and 15% of taking the medication experience dizziness or drowsiness, and these side effects are worsened when accompanied by alcohol or hormonal contraceptives.
Viagra’s side effects, on the other hand, are usually “mild and brief” and include headache and facial flushing, indigestion, blue-tinted vision and in some cases, a stuffy nose.
Side effects aside, the drugs work in completely different ways. While Viagra’s focus is mainly physiological—the drug increases blood flow to the penis—flibanserin is about adjusting one’s neurochemical balances in order to affect sexual desire, a much trickier feat. Flibanserin, which started out as an antidepressant, increases dopamine and stimulates certain receptors in the brain while blocking others.
While a man can pop Viagra an hour or so before he plans to have sex, women who are looking for increased sexual desire need to take Addyi daily for up to a month before they should expect to see any effects.
Critics say the drug is an example of the pharmaceutical manufacturing a drug of questionable efficacy to treat a questionable disorder. During clinical trials in 2013, only between 8% and 13% of women experienced “much improved” sexual desire. Women taking the drug have reported up to two more “satisfying sexual events” each month, a number some say isn’t worth all the potential side effects.
Nonetheless, Addyi will go on sale in October.