"U.S. health officials have expanded approval of a much-debated drug aimed at boosting female libido, saying the once-a-day pill can now be taken by postmenopausal women up to 65 years old. The announcement Monday from the Food and Drug Administration broadens the drug's use to older women who have gone through menopause. The pill, Addyi, was first approved 10 years ago for premenopausal women who report emotional stress due to low sex drive."
"Addyi, marketed by Sprout Pharmaceuticals, was initially expected to become a blockbuster drug, filling an important niche in women's health. But the drug came with unpleasant side effects including dizziness and nausea, and it carries a safety warning about the dangers of combining it with alcohol. The boxed warning cautions that drinking while consuming the pill can cause dangerously low blood pressure and fainting. If patients have several drinks, the label recommends waiting a few hours before taking the drug, or skipping one dose."
"Sales of Addyi, which acts on brain chemicals that affect mood and appetite, fell short of Wall Street's initial expectations. In 2019, the FDA approved a second drug for low female libido, an on-demand injection that acts on a different set of neurological chemicals. Sprout CEO Cindy Eckert said in a statement the approval "reflects a decade of persistent work with the FDA to fundamentally change how women's sexual health is understood and prioritized.""
FDA approval now allows Addyi, a once-daily pill, for postmenopausal women up to 65 to treat hypoactive sexual desire disorder. Addyi was first approved ten years ago for premenopausal women reporting emotional stress from low sex drive. The drug acts on brain chemicals tied to mood and appetite. Side effects include dizziness and nausea, and a boxed warning cautions that combining Addyi with alcohol can cause dangerously low blood pressure and fainting; labels advise waiting several hours or skipping a dose after drinking. Sales fell short of expectations, and a different on-demand injectable for low female libido was approved in 2019.
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