Opioids with abuse-deterrent properties: A regulatory and technological overview

Area of Science:

• Pharmacology
• Public Health
• Drug Development

Background:

• The US faces a severe opioid crisis marked by widespread misuse, overdose deaths, and chronic pain.
• This crisis has driven the development of opioid formulations with abuse-deterrent properties and label claims (OADP).

Purpose of the Study:

• To review the epidemiology of the opioid crisis.
• To summarize the FDA's guidance for developing abuse-deterrent opioids (OADP).
• To provide an overview of current and emerging abuse-deterrent technologies.

Main Methods:

• Review of opioid crisis epidemiology.
• Analysis of FDA Guidance for Industry on abuse-deterrent testing.
• Overview of various abuse-deterrent technologies.

Main Results:

• OADP technologies include physical/chemical barriers, agonist-antagonist combinations, aversive agents, and novel delivery systems.
• New molecular entities and prodrugs are also under development.
• Combined approaches are being formulated to enhance deterrence.

Conclusions:

• Abuse-deterrent opioids (OADP) are a key component of a comprehensive strategy to mitigate the opioid crisis.
• These formulations aim to deter abuse without hindering safe use for legitimate pain management.
• Widespread adoption of FDA-recognized OADP is expected to maximize public health benefits.