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

Beatrice Setnik, Edward J. Cone

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)96-100
Number of pages5
JournalJournal of Opioid Management
Volume12
Issue number2
DOIs
StatePublished - May 1 2016
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)

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