Establishing "Abuse-Deterrence Equivalence" for Generic Abuse-Deterrent Opioid Formulations: A Proposed Development Framework

J Opioid Manag. May-Jun 2016;12(2):96-100. doi: 10.5055/jom.2016.0320.

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.

MeSH terms

  • Analgesics, Opioid / adverse effects*
  • Analgesics, Opioid / chemistry
  • Analgesics, Opioid / pharmacokinetics
  • Animals
  • Chemistry, Pharmaceutical
  • Clinical Trials as Topic
  • Drug Approval / methods*
  • Drug Evaluation, Preclinical
  • Drugs, Generic / adverse effects*
  • Drugs, Generic / chemistry
  • Drugs, Generic / pharmacokinetics
  • Epidemics
  • Humans
  • Opioid-Related Disorders / epidemiology
  • Opioid-Related Disorders / prevention & control*
  • Prescription Drugs / adverse effects*
  • Prescription Drugs / chemistry
  • Prescription Drugs / pharmacokinetics
  • Risk Assessment
  • Therapeutic Equivalency

Substances

  • Analgesics, Opioid
  • Drugs, Generic
  • Prescription Drugs