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Abuse-Deterrent Opioid Formulations.

Labeling Requirements For claims of abuse deterrence to be included in the labeling of an opioid formulation, the FDA requires that laboratory tests first be performed to assess how easily the abuse-deterrent properties of the formulation can be compromised. In vivo studies should then compare the pharmacokinetic profiles of the formulation before and after manipulation. Based on these results, a randomized, doubleblind, placeboand active-controlled study should evaluate subjective effects of the formulation, such as differences in “drug liking” in recreational drug users. Postmarketing epidemiological studies are required for all opioid formulations that have claims of abuse deterrence in their labeling. These studies assess whether a formulation has been associated with meaningful reductions in adverse clinical outcomes related to abuse and misuse.