“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 Centre for Drug Evaluation and Research/AFP
Made by North Carolina-based Sprout Pharmaceuticals, Addyi, also known as flibanserin, received the nod from the US Food and Drug Administration, on the condition that extra care is taken to ensure women do not take it with alcohol due to the risk of serious side effects.
“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 Centre for Drug Evaluation and Research.
The FDA approved Addyi specifically for a condition known as “acquired, generalized hypoactive sexual desire disorder (HSDD),” or sudden and severe loss of libido.
“Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women,” the agency said.
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 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.
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