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.
Key words: Opioid abuse, abuse-deterrent formulations, ADF, post-marketing, FDA guidance, cost
impact, abuse liking, physician attitude, generic abuse-deterrent formulation, clinical application
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