Editor's Note:
Addressing the ongoing opioid epidemic in the United States is a complicated task, necessitating a variety of approaches, including education of clinicians and patients, guidance for clinicians on pain management, development of alternative strategies for treating pain, and new regulations (such as prescription drug monitoring programs) to monitor for and detect misuse and abuse of opioids. Critical to the success of these prevention efforts is the development of pain drugs with abuse-deterrent properties. Medscape spoke with Douglas Throckmorton, MD, deputy director for regulatory programs at the Center for Drug Evaluation and Research at the US Food and Drug Administration (FDA), about these up-and-coming formulations designed to reduce the risk for misuse and abuse of opioids.
Opioid Abuse-Deterrent Formulations
Medscape: Can you define abuse-deterrent properties? What makes these products less likely to be abused?
Douglas Throckmorton, MD, deputy director for regulatory programs, Center for Drug Evaluation and Research, US Food and Drug Administration
Dr Throckmorton: The term "abuse-deterrent" is often misunderstood to mean "abuse-proof." Abuse-deterrent properties are defined as those properties expected to meaningfully deter abuse, even if they do not fully prevent it. Abuse-deterrent properties make certain types of abuse, such as crushing in order to snort or dissolving in order to inject, more difficult or less rewarding. This does not mean that the product is impossible to abuse or that these properties will necessarily prevent addiction, overdose, or death.
Of note, currently marketed abuse-deterrent formulation technologies do not effectively deter one of the most common forms of opioid abuse—which is simply swallowing a number of intact tablets or capsules. Abuse-deterrent opioids do not reduce the risk for opioid addiction, and they carry the same warnings about the risk for addiction as conventional opioids.
Medscape: Can you discuss the data examining the effect that abuse-deterrent opioids could have on misuse and abuse of these products in the community?
Dr Throckmorton: This is an area the agency has been working on for a number of years, and we are prioritizing the need for data and study methods that will help evaluate the impact of abuse-deterrent opioids on misuse and abuse in the community. To collect this important information, FDA is requiring all of the companies that have brand-name opioids with labeling describing abuse-deterrent properties to conduct postmarket studies to determine the impact of abuse-deterrent formulation technologies in the real world. Each company is given a timeline to which they must adhere. These types of studies take several years to conduct and analyze. Data collected will include the amount of prescribing for each product; adverse events related to the use, abuse, and misuse of the products; and epidemiologic data on the rates of abuse and misuse and their consequences (addiction, overdose, and death).
The studies should allow the FDA to assess the impact, if any, attributable to the abuse-deterrent properties in the community. Having that information is critical and will allow us to determine the next steps in this area. It's important to understand that the science of abuse deterrence is relatively new, and both the formulation technologies and the analytical, clinical, and statistical methods for evaluating those technologies are rapidly evolving.
Medscape: How many products with these properties have been approved? How do they differ, and are there clinical scenarios that are particularly appropriate for each?
Dr Throckmorton: To date, the FDA has approved seven extended-release/long-acting (ER/LA) opioids with labeling describing abuse-deterrent properties (Table) that remain consistent with the FDA's 2015 final guidance for industry, Abuse-Deterrent Opioids—Evaluation and Labeling.
Table. Abuse-Deterrent Products
| Product | Formulation | Approval Date |
|---|---|---|
| OxyContin® | Oxycodone—crush/extraction resistant | April 2013 |
| Targiniq™ ER | Oxycodone hydrochloride and naloxone | July 2014 |
| Embeda® | Morphine sulfate and naltrexone | October 2014 |
| Hysingla™ ER | Hydrocodone—crush/extraction resistant | November 2014 |
| Morphabond™ | Morphine sulfate—crush/extraction resistant | October 2015 |
| Xtampza™ ER | Oxycodone—crush/extraction resistant | April 2016 |
| Troxyca® ER | Oxycodone hydrochloride and naltrexone hydrochloride | August 2016 |
ER = extended-release
Prescribers should carefully review the labeling of these products for more detailed information on the routes of abuse that each product is expected to deter and the studies that support those conclusions.
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Cite this: Abuse-Deterrent Opioids: What You Need to Know - Medscape - Aug 25, 2016.
