The Food and Drug Administration has approved a historic first in women’s sexual health. Prescription Addyi is now approved to treat low sexual desire in postmenopausal women under 65.
The pill was previously only approved for premenopausal women when it launched in 2015.
Addyi treats hypoactive sexual desire disorder, which affects an estimated 40% of women.
The FDA gave the expanded approval priority review status for addressing an unmet medical need.
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Sprout Pharmaceuticals says the decision closes a care gap for millions of postmenopausal women.
The company’s CEO said the approval shows how far women’s sexual health has advanced in the last decade.
"This milestone reflects a decade of persistent work with the FDA to fundamentally change how women's sexual health is understood and prioritized," said Cindy Eckert, founder and CEO of Sprout Pharmaceuticals. "Over the years, we've pushed for the science to speak louder than the stigma — and today's approval shows how far we've come. I want to congratulate the FDA for recognizing what millions of women have long deserved: equitable, science-backed care at every stage of life."
The drug is intended to be used on a daily basis and can take up to four weeks to show results.
The drug is not intended for women whose low sexual desire is due to a medical or mental health problem, problems in the relationship or medicine or other drug use.
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