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2w ago

FDA Expands Addyi Approval to Postmenopausal Women Over 65

The move keeps the drug’s alcohol box warning in place after years of limited uptake.

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)
Image
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

  • The FDA said the once-daily pill can now be prescribed to women older than 65 who have gone through menopause.
  • Addyi was first approved in 2015 for premenopausal patients who report distress caused by low sexual desire.
  • The drug’s safety profile is unchanged, with common side effects such as dizziness and nausea and a boxed warning that alcohol use can cause dangerously low blood pressure and fainting.
  • Despite early expectations, sales have remained modest, and a 2019 FDA-cleared on-demand injection provides an alternative that targets different brain pathways.
  • Sprout Pharmaceuticals announced the decision and CEO Cindy Eckert praised the outcome, as debate continues over diagnosing and treating hypoactive sexual desire disorder.