The following is an abstract of Dr. Green’s presentation titled “Measures of ADF Effectiveness: Alignment of Intended Impact and Postmarket Outcome Measures.”
Jody L Green, PhD, CCRP
Chief Scientific Officer
Measures of ADF Effectiveness: Alignment of Intended Impact and Postmarket Outcome Measures
The current key outcome measures specified by the Food and Drug Administration (FDA) in relation to assessment of the effectiveness of abuse-deterrent formulations are abuse, misuse, addiction, overdose, and death. As more real-world experience is gained, an evaluation of the relationship between ADF products and these outcome measures is warranted. Using the NAVIPPRO ASI-MV program, self-reported opioid-related overdoses are studied in relation to reported prescription opioid route of administration. This presentation will illustrate the relation between overdose and reported routes of administration, specifically for patients who report prescription opioid use via 1) oral route only and 2) at least one non-oral route. Discussion will follow as to the potential of advancing this new methodology for product-specific analyses and how to further align the outcome measures with the anticipated and reasonable impact of products with abuse-deterrent properties.