Table 3.

FDA Guidelines for the Approval of ADF Labeling15, 75

Category	Type of Studies	Description	Goals
1	Laboratory manipulation and extraction	Studies designed to evaluate physiochemical properties and characterize a product's abuse‐deterrent properties, as well as the degree of effort required to defeat those properties	The product is formulated with physiochemical barriers of abuse
2	Pharmacokinetic	Studies designed to compare pharmacokinetic profiles of an intact and manipulated ADF product to a comparator drug through 1 or more routes of administration	Manipulation of the product does not increase the rate/extent of opioid release or receptor binding
3	Clinical abuse potential	Studies conducted in drug‐experienced, recreational user populations designed to assess the impact of potentially abuse‐deterrent properties	The product is expected to result in a meaningful reduction in abuse
4	Postmarket	Studies designed to determine whether an ADF product results in meaningful reductions in abuse, misuse, and related adverse clinical outcomes	The product has demonstrated reduced abuse in the community

ADF, abuse‐deterrent formulation; FDA, U.S. Food and Drug Administration.

Adapted with permission from Nguyen et al., J Clin Pharm Ther. 2015;40:629–634; © 2015 John Wiley & Sons Ltd75; with additional data from the U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research.15