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# FDA Draft Guide on Drugs for Women With Low Sexual Interest
- URL: https://www.fdaweb.com/fda-draft-guide-on-drugs-for-women-with-low-sexual-interest/
- Published: 2016-10-25T12:00:00.000Z
- Updated: 2026-09-14T21:42:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137171

FDA has released a [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM526362.pdf?ref=fdaweb.com) on “Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment” that is intended to assist sponsors in developing such drugs. The document addresses the agency’s current thinking regarding the overall clinical development program, with a focus on Phase 3 trial designs. FDA says the symptoms of the conditions are not considered to be caused by a coexisting medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance

Additionally FDA says the guidance is intended to serve as a focus for continued discussions between sponsors and CDER’s Division of Bone, Reproductive, and Urologic Products. The diagnostic criteria for disorders of low sexual interest, desire, and/or arousal in women were recently revised in the fifth edition of the *Diagnostic and Statistical Manual of Mental Disorders*, it adds.