TY - JOUR
T1 - Current impact and application of abuse-deterrent opioid formulations in clinical practice
AU - Lee, Ya Han
AU - Brown, Daniel L.
AU - Chen, Hsiang Yin
N1 - Funding Information:
The authors acknowledge research funding from Taiwan Food and Drug Administration (MOHW105-FDA-D-114-000611), supporting the development of this manuscript. The funding organization was not involved in the study design, data analysis, interpretation, or in the decision to submit the manuscript for publication. The authors also acknowledge Dr. Mary J. Ferrill for her contribution to literature evaluation in this study. The authors bear all responsibility and have no conflicts of interest to declare.
PY - 2017/11/1
Y1 - 2017/11/1
N2 - Background: Abuse-deterrent formulations (ADFs) represent one novel strategy for curbing the potential of opioid abuse. Objective: We aim to compare and contrast the characteristics and applications of current abusedeterrent opioid products in clinical practice. Methods: Literature searches were conducted in databases (Pubmed Medline, International Pharmaceutical Abstracts, Google Scholar) and official reports. Relevant data were screened and organized into: 1) epidemiology of opioid abuse, 2) mitigation strategies for reducing opioid abuse, 3) development of ADFs, and 4) clinical experience with these formulations. Results: Increasing trends of opioid abuse and misuse have been reported globally. There are 5 types of abuse-deterrent opioid products: physical chemical barrier, combined agonist/antagonist, sequestered aversive agent, prodrug, and novel delivery system. The advantages and disadvantages of the 5 options are discussed in this review. A total of 9 products with abuse-deterrent labels have been approved by the Food and Drug Administration (FDA). The rates of abuse, diversion, and overdose deaths of these new products are also discussed. A framework for collecting in-time data on the efficacy, benefit and risk ratio, and cost-effectiveness of these new products is suggested to facilitate their optimal use. Limitations: The present review did not utilize systematic review standards or meta-analytic techniques, given the large heterogeneity of data and outcomes reviewed. Conclusions: ADFs provide an option for inhibiting the abuse or misuse of oral opioid products by hindering extraction of the active ingredient, preventing alternative routes of administration, or causing aversion. Their relatively high costs, uncertain insurance policies, and limited data on pharmacoeconomics warrant collaborative monitoring and assessment by government agencies, pharmaceutical manufacturers, and data analysis services to define their therapeutic role in the future.
AB - Background: Abuse-deterrent formulations (ADFs) represent one novel strategy for curbing the potential of opioid abuse. Objective: We aim to compare and contrast the characteristics and applications of current abusedeterrent opioid products in clinical practice. Methods: Literature searches were conducted in databases (Pubmed Medline, International Pharmaceutical Abstracts, Google Scholar) and official reports. Relevant data were screened and organized into: 1) epidemiology of opioid abuse, 2) mitigation strategies for reducing opioid abuse, 3) development of ADFs, and 4) clinical experience with these formulations. Results: Increasing trends of opioid abuse and misuse have been reported globally. There are 5 types of abuse-deterrent opioid products: physical chemical barrier, combined agonist/antagonist, sequestered aversive agent, prodrug, and novel delivery system. The advantages and disadvantages of the 5 options are discussed in this review. A total of 9 products with abuse-deterrent labels have been approved by the Food and Drug Administration (FDA). The rates of abuse, diversion, and overdose deaths of these new products are also discussed. A framework for collecting in-time data on the efficacy, benefit and risk ratio, and cost-effectiveness of these new products is suggested to facilitate their optimal use. Limitations: The present review did not utilize systematic review standards or meta-analytic techniques, given the large heterogeneity of data and outcomes reviewed. Conclusions: ADFs provide an option for inhibiting the abuse or misuse of oral opioid products by hindering extraction of the active ingredient, preventing alternative routes of administration, or causing aversion. Their relatively high costs, uncertain insurance policies, and limited data on pharmacoeconomics warrant collaborative monitoring and assessment by government agencies, pharmaceutical manufacturers, and data analysis services to define their therapeutic role in the future.
KW - ADF
KW - Abuse liking
KW - Abuse-deterrent formulations
KW - Clinical application
KW - Cost impact
KW - FDA guidance
KW - Generic abuse-deterrent formulation
KW - Opioid abuse
KW - Physician attitude
KW - Post-marketing
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M3 - Review article
C2 - 29149148
AN - SCOPUS:85035020735
SN - 1533-3159
VL - 20
SP - E1003-E1023
JO - Pain Physician
JF - Pain Physician
IS - 7
ER -