FDA Expands Approval of Libido Drug Addyi to Include Postmenopausal Women

The Food and Drug Administration (FDA) has broadened its approval of Addyi, a drug designed to increase sexual desire in women. The agency announced Monday that postmenopausal women up to the age of 65 are now eligible to take the once-daily pill.

Previously, Addyi was only approved for premenopausal women who reported distress from low sexual desire. Sprout Pharmaceuticals markets the drug.

While Addyi was initially predicted to be a major breakthrough in women's health, its sales have not met expectations. The drug can cause side effects such as dizziness and nausea. It also carries a warning about potential dangers when taken with alcohol. The drug's label advises that combining Addyi with alcohol can lead to dangerously low blood pressure and fainting. The label recommends waiting several hours after consuming alcohol before taking Addyi, or skipping a dose altogether.

Addyi affects brain chemicals that influence mood and appetite. In 2019, the FDA approved a second drug for low female libido, an on-demand injection that works on different neurological chemicals.

Sprout CEO Cindy Eckert stated that 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, based in Raleigh, North Carolina, made the announcement in a press release on Monday.

Medical experts have recognized hypoactive sexual desire disorder, the condition characterized by a noticeably low sexual appetite, since the 1990s. Surveys suggest it affects a considerable percentage of women in America. Following the success of Viagra for men, pharmaceutical companies invested heavily in researching potential treatments for female sexual dysfunction.

Diagnosing the condition can be complex because numerous factors, particularly hormonal changes following menopause, can impact libido. Doctors should rule out other potential causes, such as relationship issues, medical conditions, depression, and other mental health disorders, before prescribing medication.

Some psychologists dispute the diagnosis, arguing that low sex drive should not be considered a medical issue.

Prior to its approval in 2015, the FDA rejected Addyi twice, citing its limited effectiveness and potential side effects. The approval followed a lobbying effort by the company and its supporters, Even the Score, who argued that the lack of treatment options for female libido was a women's rights issue.

[This story has been updated to correct the age range of the FDA approval update. The agency approved the drug for postmenopausal women up to age 65, not older than 65.]