US regulators approved Tuesday the first drug designed to boost women’s sex drive, a pill that has been nicknamed the “female Viagra” but is known by the trade name Addyi.
Also known as flibanserin, the drug is made by Sprout Pharmaceuticals in North Carolina and is aimed at premenopausal women who have lost interest in sex.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, director of the Food and Drug Administration’s Center for Drug Evaluation and Research.
The FDA approved Addyi specifically for a condition known as “acquired, generalized hypoactive sexual desire disorder (HSDD),” the agency said in a statement.
“Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.”
The disorder can develop in women who previously were sexually active, causing distress and relationship problems, “and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance,” the FDA said.
The drug must not be taken with alcohol, and will only be available at certified pharmacies because of the potentially serious interaction with alcohol, including risks such as fainting and severely low blood pressure.
“Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment,” Woodcock added.