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Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations.
Pain
October 2012
University of Washington, Seattle, Washington, USA University of Rochester, Rochester, New York, USA Johns Hopkins University, Baltimore, Maryland, USA Analgesic Solutions and Tufts University, Boston, Massachusetts, USA Covance, Conshohocken, Pennsylvania, USA Harvard Medical School, Boston, Massachusetts, USA Columbia University, New York, USA Denver Health Authority and Rocky Mountain Poison and Drug Center, Denver, Colorado, USA University of North Carolina, Chapel Hill, North Carolina, USA National Institute on Drug Abuse, Bethesda, Maryland, USA United States Food and Drug Administration, Silver Spring, Maryland, USA CNS Drug Consulting, McLean, Virginia, USA University of Chicago, Chicago, Illinois, USA Endo Pharmaceuticals, Chadds Ford, Pennsylvania, USA American Chronic Pain Association, Rocklin, California, USA AstraZeneca Pharmaceuticals, Wilmington, Delaware, USA Brigham and Women's Hospital, Boston, Massachusetts, USA AcelRx Pharmaceuticals, Redwood City, California, USA University of Texas Health Science Center San Antonio, San Antonio, Texas, USA Johnson & Johnson Pharmaceutical Research & Development, Titusville, New Jersey, USA Pfizer, New Brunswick, New Jersey, USA Clinical Research and Pain Clinic, Salt Lake City, Utah, USA NAMA Recovery, Cedar Park, Texas, USA.
Opioids are essential to the management of pain in many patients, but they also are associated with potential risks for abuse, overdose, and diversion. A number of efforts have been devoted to the development of abuse-deterrent formulations of opioids to reduce these risks. This article summarizes a consensus meeting that was organized to propose recommendations for the types of clinical studies that can be used to assess the abuse deterrence of different opioid formulations.
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