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# Opioid Disorder Effectiveness Endpoint Guidance
- URL: https://www.fdaweb.com/opioid-disorder-effectiveness-endpoint-guidance/
- Published: 2020-10-01T12:00:00.000Z
- Updated: 2026-09-14T16:31:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147779

FDA has published a guidance, *Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment*, to help sponsors develop drugs to treat opioid use disorder. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/opioid-use-disorder-endpoints-demonstrating-effectiveness-drugs-medication-assisted-treatment?ref=fdaweb.com) addresses clinical endpoints acceptable for demonstrating the effectiveness of such drugs. It does not address the development of drugs intended only to provide symptomatic relief of opioid withdrawal.

Contents of the guidance are Introduction, Background, Clinical Endpoints, Other Outcome Measures, and Benefit-Risk Considerations.