Advancements in Abuse Deterrence

Scientifically driven solutions are needed to help combat opioid abuse, including potential abuse deterrent technologies.

Evolving Strategies Address Abuse Potential

According to the CDC, opioid abuse is the nation's fastest growing drug problem and it ranks among the top three for prescription drug abuse. 3 Scientifically driven solutions are needed to help combat this serious public health epidemic, including: Strategies to mitigate risk, Abuse deterrence technology, and continued scientific research.5

In April 2015, the Food and Drug Administration (FDA) issued guidance to assist the pharmaceutical industry in developing new formulations of opioid drug products with potentially abuse-deterrent properties,5 which it believes have promise to help reduce, though not necessarily prevent, opioid abuse.5

Studies Evaluate New Potentially Abuse Deterrent Technologies

In order to assess the impact of a potentially abuse-deterrent product, the FDA recommends looking at data from the below categories of pre-and postmarket studies.

Category 1: Laboratory Manipulation and Extraction Studies

Category 2: Pharmacokinetic Studies

Category 3: Clinical Abuse Potential Studies

Category 4: Postmarket Studies

Labeling for Abuse Deterrent Opioid Formulations

Labeling for an abuse deterrent product should include a description of the abuse deterrent properties, as well as the specific routes of abuse that the product has been developed to deter, to inform healthcare professionals, the patient community, and the public about a product’s abuse potential. The FDA also encourages pharmaceutical companies to include the results of premarket studies in Categories 1, 2, and 3, and formal Category 4 postmarket studies.

When premarket data show that a product’s abuse-deterrent properties can be expected to result in a meaningful reduction in that product’s abuse, these data are included in product labeling. When postmarket data become available, that data may also be added to the product labeling. If the postmarket data do not demonstrate a reduction in abuse, or if the data demonstrate a shift in routes of abuse that represent a greater risk, the FDA may determine that labeling revisions are needed.

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 guidance to assist the pharmaceutical industry to develop new formulations of opioid drugs with abuse-deterrence properties.5 Most abuse-deterrence technologies developed to date are designed to make product manipulation more difficult, and abuse of the manipulated product less attractive or rewarding.

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