FDA Offers Draft Guidance on Abuse-deterrent Opioids

The U.S. Food and Drug Administration today issued a draft guidance document to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties. It describes the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, how those studies will be evaluated by the agency, and what labeling claims may be approved based on the results of those studies.