Establishing “abuse-deterrence equivalence” for generic abuse-deterrent opioid formulations: A proposed development framework

Beatrice Setnik, PhD; Edward J. Cone, PhD

doi:10.5055/jom.2016.0320

Authors

Beatrice Setnik, PhD
Edward J. Cone, PhD

DOI:

https://doi.org/10.5055/jom.2016.0320

Keywords:

abuse-deterrence equivalence, abuse-deterrent formulation, generics, opioids

Abstract

Abuse-deterrent formulations are one strategy for mitigating the epidemic of prescription opioid abuse. Regulatory guidance documents describe the requirements for developing abuse-deterrent formulations of novel drugs and formulations; however, they do not address “abuse-deterrence equivalence” for generic formulations. As generics may be produced with different excipients and formulations compared to reference drugs, differences in their properties may impact their abuse-deterrent features. Currently, it is unclear what specific studies are needed to support generic abuse-deterrence claims. This commentary outlines several recommendations on the in vitro and in vivo testing required, including the conditions for conducting a human abuse potential study.

Author Biographies

Beatrice Setnik, PhD

VP Clinical Pharmacology, INC Research, Raleigh, North Carolina

Edward J. Cone, PhD

Principal Scientist, Pinney Associates, Bethesda, Maryland

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