The FDA has approved flibanserin, a desire-enhancing drug for women that has been dubbed “Female Viagra”.
The Sprout Pharmaceuticals drug recently passed an FDA advisory committee meeting.
The non-hormonal pill is designed to assist premenopausal women regain their desire by boosting levels of certain brain chemicals.
However, flibanserin has been criticized as having marginal effects.
Versions of the pill, which will be marketed as “Addyi”, have been submitted for approval in the past but never passed.
The drug was rejected by the FDA twice for lack of effectiveness with results experts admitted were “modest” and side effects like nausea, dizziness and fainting.
Originally the drug was produced by German company Boehringer Ingelheim. Sprout bought the drug from that company after it was turned down by the FDA.
Documents from the June 4 FDA advisory meeting describe the drug’s purpose as “treatment of hypoactive s**ual desire disorder (HSDD) in premenopausal women”.
Women would take it each night.
A doctor would have to determine whether a woman seeking the pill was suffering from a disorder characterized by a lack of desire, causing the woman distress.
Currently, there is nothing on the US market approved for treatment of HSDD or another condition, female s**ual interest/arousal disorder (FSIAD).
“This condition is clearly an area of unmet medical need,” the FDA documents said.
Sprout only has 25 employees. Large pharmaceutical companies like Pfizer, Bayer and Proctor & Gamble have all studied female desire disorder treatment but abandoned plans to pursue it.
Sprout’s CEO, Cindy Whitehead, told AP they would promote Addyi carefully.
“We would never want a patient who’s not going to see a benefit to take it and tell everyone it doesn’t work,” she said.
Lobbying by Sprout Pharmaceuticals was backed by the women’s rights group Even the Score, which has accused the FDA of gender bias by approving a number of drugs treating men’s issues without passing an equivalent for women.