Opioid use disorder : endpoints for demonstrating effectiveness of drugs for treatment Guidance for industry United States. Department of Health and Human Services United States. Food and Drug Administration Analgesics, Opioid Opioid-Related Disorders -- drug therapy This guidance is intended to help sponsors develop drugs for treatment of opioid use disorder (OUD). This guidance addresses clinical endpoints acceptable for demonstrating effectiveness of such drugs. This guidance does not address the development of drugs intended only to provide symptomatic relief of opioid withdrawal. For assistance on specific drug development programs to treat OUD, sponsors should contact the Division of Anesthesiology, Addiction Medicine, and Pain Medicine (the division) in the Center for Drug Evaluation and Research. Silver Spring, MD : Center for Drug Evaluation and Research, October 2020 United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Technical Report Text 1 online resource (1 PDF file (6 pages)). nlm:nlmuid-9918231297206676-pdf 9918231297206676 http://resource.nlm.nih.gov/9918231297206676 English United States The National Library of Medicine believes this item to be in the public domain. https://creativecommons.org/publicdomain/mark/1.0