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Issue 1, Volume 3
Abuse-Deterrent Technologies

About the Authors

14 Articles in this Series
The effect of a potentially tamper-resistant oxycodone
Commentary: Why Prescribers Need to Adopt Abuse-Deterrent Opioids
Review: The Impact of Abuse-Deterrent Formulations on Prescribing and Abuse
Abuse-Deterrence Guidance Further Highlights Federal Focus
The Burden of Undiagnosed Opioid Abuse Among the Commercially Insured
Reductions in Reported Deaths Following Introduction of Abuse-Deterrent Oxycodone ER (OxyContin)
Abuse-Deterrent Opioids—Evaluation and Labeling
Generic patches containing fentanyl: abuse deterrent evaluation
FDA Advisory Committee Meetings on Abuse-Deterrent Opioids
Regulatory Update: FDA Takes Additional Abuse-Deterrent Steps
Related: At-Risk Patients and Urine Drug Monitoring
Extended-Release Formulations Enter US Market
Development and Impact of Prescription Opioid ADF Technologies
Trends in Opioid Analgesic Abuse and Mortality in the United States


Welcome from Michael J. Brennan, MD, and Jeffrey Gudin, MD

This literature review series began in 2015 and continues to provide details, updates, and expert insights into the growing focus on abuse-deterrent formulations and technologies and their role in chronic pain management.

Opioid overdose is a major public health problem, accounting for almost 17,000 deaths per year in the United States.1 Overdose occurs in both males and females of all ages, ethnicities, and demographics, and involves both prescription opioid analgesics such as oxycodone, hydrocodone, morphine, and methadone, and increasingly illicit opioids such as heroin and fentanyl.2

Physicians and other healthcare providers can reduce the risk of opioid adverse effects with thoughtful prescribing and monitoring of patient responses. Clinicians need a thorough understanding of the inherent pharmacologic properties of a particular opioid analgesic, and to recognize the nuances of each formulation or delivery system (ie, controlled release, immediate release, or rapid onset) they prescribe. Care needs to be taken when prescribing these agents concomitantly with other central nervous system depressants, and a “Universal Precautions” approach has been recommended for all patients being considered for chronic opioid therapy.3

Some of these precautions include psychological screening, urine (or other matrix) toxicology testing, prescription drug monitoring database programs, informed consent, and ongoing risk assessment. The FDA's Risk Evaluation and Mitigation Strategy (REMS) introduced new safety measures to reduce risks and improve the safe use of extended-release/long-acting opioids while continuing to provide access to these medications for patients in pain.

The Substance Abuse and Mental Health Services Administration recognizes that healthcare practitioners, communities, workplaces, patients, and families all can contribute to preventing prescription drug abuse, and has an Opioid Overdose Prevention Toolkit, which describes strategies to prevent opioid overdose for all of these groups.

See also PPM's October 2018 themed issue on ADFs and Opioid Alternatives.

Abuse-Deterrent Formulations

Academic researchers and pharmaceutical companies also have taken ownership and a stake in the prevention of abuse, misuse, diversion, and overdose of prescription opioids. “While prescription opioids are an important component of pain management, abuse and misuse of these products have resulted in too many injuries and deaths across the United States,” said Douglas Throckmorton, MD, Deputy Director for Regulatory Programs in the FDA's Center for Drug Evaluation and Research. “An important step towards the goal of creating safer opioids is the development of products that are specifically formulated to deter abuse.”4

To combat opioid misuse and abuse, the FDA is encouraging manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed, and are formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high. While drugs with abuse-deterrent properties are not “abuse-proof,” the FDA sees this guidance as an important step toward balancing appropriate access to opioids for patients with pain with the importance of reducing opioid misuse and abuse. The agency issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.

The document “Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling” was reviewed in our introductory issue of this PainScan, and explains the FDA’s thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties.5 It also makes recommendations about how those studies should be performed and evaluated, and discusses what labeling claims may be approved based on the results of those studies.


The Centers for Disease Control and Prevention has classified prescription drug abuse as an epidemic. While the use of some illegal drugs like cocaine has markedly decreased in recent years, prescription and illicit drug abuse is a growing problem. According to results from a National Survey on Drug Use and Health (NSDUH), nearly one-third of people aged 12 and older who used drugs for the first time began by using a prescription drug non-medically.6 A White House Prescription Drug Abuse Prevention Plan included action in 4 major areas to reduce prescription drug abuse: education, monitoring, proper disposal, and enforcement.7

In addition to these governmental efforts, abuse-deterrent and tamper-resistant pharmaceutical formulations of controlled substances have and are being developed to maintain the efficacy and improve the safety of these valuable analgesic medications. Opioids may be the only effective therapies for patients suffering from severe chronic pain.

Studies of cost-effectiveness also will be necessary, in addition to studies of efficacy, safety, and abuse deterrence.8 The acceptance of newer abuse-deterrent drug formulations will require endorsement from clinicians, patients, governmental agencies and third-party payors who typically favor less expensive, non-abuse deterrent generic opioids on their formularies. In order for these agents to be widely prescribed, insurers will need to cover tamper-resistant opioids without the expected roadblocks of lengthy preauthorizations or higher copays. As more postmarketing data about the effectiveness of ADFs becomes available, insurers will be better able to calculate the pharmacoeconomic benefits of these agents in order to justify the additional upfront expense.

In this evolving PainScan, we continue to review influential studies on abuse-deterrent and other opioid technologies to keep readers up to date on the progress being made in this field and the impact of these technologies on reducing the risk for opioid abuse, misuse, and overdose.

First Article:
The effect of a potentially tamper-resistant oxycodone
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