FDA Adds New Co-Primary Endpoint For Female Sexual Desire Drugs

Draft guidance says 'associated distress' may replace number of satisfying sexual events as a co-primary efficacy endpoint.

FDA has heeded a recommendation by scientific experts and agreed that “associated distress” may be a co-primary endpoint for clinical trials of drugs intended to treat low sexual interest, desire, and/or arousal disorders, in the place of number of “satisfying sexual events.”

The agency noted its acceptance of this co-primary endpoint in its just-released draft guidance, "Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment

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