Understanding Abuse Deterrence Technology

Understanding Abuse Deterrence Technology and How It Works in the Changing Chronic Pain Management Landscape

Abuse deterrence technology must continue to adapt to the changing chronic pain management landscape, though this technology does not completely eliminate the risk of abuse.5 Abuse deterrence technologies are just one of the measures physicians can employ to help mitigate the risk of opioid abuse and misuse. This video provides an overview of opioid abuse, including the FDA guidance on abuse deterrence technology.5

Abuse Deterrence Technology Formulations Target Known Routes of Abuse

In April 2015, the FDA issued a guidance document to assist the pharmaceutical industry to develop new formulations of opioid drug products with potentially abuse-deterrent properties.5 Most abuse-deterrence technologies developed to date are designed to make:

  • Product manipulation more difficult
  • Abuse of the manipulated product less attractive or rewarding
Click on a deterrence category below to learn more

Physical & Chemical Barriers

Physical and chemical barriers can limit drug release following mechanical manipulation, or change the physical form of a drug, rendering it less amenable to abuse.5

  • Physical barriers can prevent chewing, crushing, cutting, grating, or grinding
  • Chemical barriers resist extraction of the opioid using common liquids like water, alcohol, or other organic solvents

Opioid Agonist/Antagonist

An opioid antagonist can be added to an opioid agonist to interfere with, reduce, or defeat the euphoria (or high) associated with abuse. For example, a drug may be formulated such that the antagonist is not clinically active when swallowed but becomes active if the product is crushed and injected or snorted.5

Aversion

Substances can be combined to produce an unpleasant effect if the dosage form is manipulated prior to ingestion or if a higher dosage than directed is used.5

New Molecular Entity or Prodrug

The properties of a new molecular entity (NME) or prodrug could include the need for enzymatic activation, different receptor binding profiles, slower penetration into the central nervous system, or other novel effects that would make the formulation less attractive for specific routes of abuse.5

Drug Delivery System

Drug delivery systems can also offer resistance to abuse.5 For example, a sustained-release depot injectable formulation that is administered intramuscularly or subcutaneous implants can be more difficult to manipulate.5

Combination

Two or more of the technologies described in this section may be combined to deter abuse.5

Novel Approaches

Novel approaches include technologies that are not captured in the previous categories.5

  • Physical & Chemical Barriers

    Physical and chemical barriers can limit drug release following mechanical manipulation, or change the physical form of a drug, rendering it less amenable to abuse.5

    Physical barriers can prevent chewing, crushing, cutting, grating, or grinding

    Chemical barriers resist extraction of the opioid using common liquids like water, alcohol, or other organic solvents

  • Opioid Agonist/Antagonist

    An opioid antagonist can be added to an opioid agonist to interfere with, reduce, or defeat the euphoria (or high) associated with abuse. For example, a drug may be formulated such that the antagonist is not clinically active when swallowed but becomes active if the product is crushed and injected or snorted.5

  • Aversion

    Substances can be combined to produce an unpleasant effect if the dosage form is manipulated prior to ingestion or if a higher dosage than directed is used.5

  • New Molecular Entity or Prodrug

    The properties of a new molecular entity (NME) or prodrug could include the need for enzymatic activation, different receptor binding profiles, slower penetration into the central nervous system, or other novel effects that would make the formulation less attractive for specific routes of abuse.5

  • Drug Delivery System

    Drug delivery systems can also offer resistance to abuse.5 For example, a sustained-release depot injectable formulation that is administered intramuscularly or subcutaneous implants can be more difficult to manipulate.5

  • Combination

    Two or more of the technologies described in this section may be combined to deter abuse.5

  • Novel Approaches

    Novel approaches include technologies that are not captured in the previous categories.5