Abuse-deterrent opioid analgesics: a guide for clinicians.
Pain Manag
; 10(1): 55-62, 2020 Jan.
Article
in En
| MEDLINE
| ID: mdl-31916895
ABSTRACT
The US FDA has encouraged the development of abuse-deterrent formulations (ADFs) of opioid analgesics as one component in a comprehensive effort to combat prescription opioid abuse. Guidance issued by the FDA outlines three types of premarket studies for evaluating abuse deterrence laboratory-based in vitro manipulation and extraction studies, pharmacokinetic studies and human abuse potential studies. After approval, postmarket studies are needed to evaluate the impact of an ADF product on abuse in real-world settings. This review summarizes the regulatory issues involved in the development of ADF opioids and clarifies abuse-deterrence claims in product labels, in order to assist clinicians in critically evaluating the available evidence pertaining to the abuse-deterrent features of opioid analgesics.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Delayed-Action Preparations
/
Analgesics, Opioid
/
Opioid-Related Disorders
Type of study:
Guideline
Limits:
Humans
Language:
En
Journal:
Pain Manag
Year:
2020
Document type:
Article
Affiliation country: