title: Establishing "abuse-deterrence equivalence" for generic abuse-deterrent opioid formulations: A proposed development framework.
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.
authors.affiliation: VP Clinical Pharmacology, INC Research, Raleigh, North Carolina.
authors.forename: Beatrice
authors.initials: B
authors.lastname: Setnik
authors.affiliation: Principal Scientist, Pinney Associates, Bethesda, Maryland.
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Cone
mesh_terms: D000701:Analgesics, Opioid / Q000009:adverse effects* / Q000737:chemistry / Q000493:pharmacokinetics; D000818:Animals; D002626:Chemistry, Pharmaceutical; D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000379:methods*; D004353:Drug Evaluation, Preclinical; D016568:Drugs, Generic / Q000009:adverse effects* / Q000737:chemistry / Q000493:pharmacokinetics; D058872:Epidemics; D006801:Humans; D009293:Opioid-Related Disorders / Q000453:epidemiology / Q000517:prevention & control*; D055553:Prescription Drugs / Q000009:adverse effects* / Q000737:chemistry / Q000493:pharmacokinetics; D018570:Risk Assessment; D013810:Therapeutic Equivalency
chemical_list: D000701:Analgesics, Opioid; D016568:Drugs, Generic; D055553:Prescription Drugs