FDA Draft Guide on Drugs for Women With Low Sexual Interest

FDA has released a draft guidance on “Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment” that is intended to assist sponsors in developing such drugs.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.