FDA Expands Addyi Approval to Postmenopausal Women Up to 65

The FDA has broadened the use of Addyi, a once‑daily pill for low libido, to include postmenopausal women up to 65, expanding its reach after a decade of work.

FDA Expands Approval

On Monday, the Food and Drug Administration announced that Addyi can now be prescribed to postmenopausal women aged 18 to 65. The agency’s update extends the drug’s label beyond its original scope, which had limited use to premenopausal women who report emotional stress related to a low sex drive. The change follows a series of interactions between Sprout Pharmaceuticals and the FDA over the past ten years.

Addyi’s History and Marketing

Addyi was first approved by the FDA ten years ago for premenopausal women who experience a low sex drive. Sprout Pharmaceuticals markets the pill under the brand name Addyi. The drug works by acting on brain chemicals that influence mood and appetite, which are linked to sexual desire. Despite early expectations of blockbuster sales, the medication has struggled to meet Wall Street’s projections.

Side Effects and Alcohol Warning

Addyi carries notable side effects, including dizziness and nausea. The boxed warning on the label cautions that consuming alcohol while taking the pill can cause dangerously low blood pressure and fainting. If a patient has had several drinks, the label advises waiting a few hours before taking the drug or skipping a dose altogether. This safety information is intended to prevent serious health risks.

Market Performance and Competition

Sales of Addyi have fallen short of initial expectations. In 2019, the FDA approved a second drug for low female libido: an on‑demand injection that targets a different set of neurological chemicals. The injection offers an alternative treatment pathway, reflecting the evolving landscape of women’s sexual health therapies.

Sprout’s Statement

Sprout CEO Cindy Eckert released a statement in a Monday press release. She said the approval “reflects a decade of persistent work with the FDA to fundamentally change how women’s sexual health is understood and prioritized.” The company, headquartered in Raleigh, North Carolina, highlighted the effort required to bring Addyi to a broader patient group.

Hypoactive Sexual Desire Disorder

The medical condition addressed by Addyi, hypoactive sexual desire disorder (HSDD), has been recognized since the 1990s. Surveys suggest it affects a significant portion of American women. The condition’s diagnosis is complex, especially after menopause when falling hormone levels trigger various biological changes and medical symptoms.

Diagnostic Challenges

Doctors must rule out a range of other issues before prescribing medication for HSDD. These include relationship problems, medical conditions, depression, and other mental disorders. Some psychologists argue that low sex drive should not be considered a medical problem, indicating that the diagnosis is not universally accepted.

FDA History and Lobbying

The FDA rejected Addyi twice before its 2015 approval, citing modest effectiveness and worrisome side effects. The eventual approval followed a lobbying campaign by Sprout Pharmaceuticals and supporters, including the group Even the Score. The campaign framed the lack of options for female libido as a women’s rights issue.

Update Correction

The FDA’s recent update corrects the age range for the expanded approval. The agency approved Addyi for postmenopausal women up to age 65, not older than 65.

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