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5d ago

FDA Expands Addyi Use to Postmenopausal Women, Including Those Over 65

The decision follows a Priority Review that cited modest benefit, with the alcohol-related safety warning unchanged.

FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, File)
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FILE - The U.S. Food and Drug Administration building is seen behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md., Aug. 2, 2018. (AP Photo/Jacquelyn Martin, File)
FILE - In this Aug. 18, 2015 file photo, Sprout Pharmaceuticals CEO Cindy Whitehead holds a bottle for the female sex-drive drug Addyi in Raleigh, N.C. (AP Photo/Allen G. Breed, File)

Overview

  • U.S. regulators on Dec. 15 broadened Addyi’s indication beyond premenopausal patients to include women after menopause, explicitly allowing use by those older than 65.
  • Addyi retains an FDA boxed warning that drinking alcohol while on the drug can trigger dangerously low blood pressure and fainting.
  • Evidence cited for the expansion includes randomized trials and a 2015–2024 meta-analysis showing modest improvements in sexual desire versus placebo.
  • The once-daily flibanserin pill targets central neurotransmitters such as serotonin to treat hypoactive sexual desire disorder.
  • Use to date has been limited due to side effects like dizziness and nausea and ongoing debate over diagnosing HSDD, which clinicians are urged to confirm only after other causes are ruled out.