Table 3.
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.