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FDA Facts: Abuse-Deterrent Opioid Medications

The FDA is encouraging the development of opioid formulations with abuse-deterrent properties to help combat the opioid epidemic. The agency recognizes that opioids with abuse-deterrent properties (AD) are not abuse-proof, but are a step toward products that will help reduce abuse. The FDA fully supports efforts to better understand the impact of these products in the real-world setting and develop innovative formulations that have the potential to make abuse of these products more difficult or less rewarding. The FDA is working with many drug makers to support advancements in this area and help drug makers navigate the regulatory path to market as quickly as possible. In working with industry, the FDA is taking a flexible, adaptive approach to the evaluation and labeling of potentially AD products.

What makes an opioid abuse-deterrent
Formulations with abuse-deterrent properties target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the specific opioid drug substance. 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.

Abuse-deterrent is not the same as abuse-proof
The fact that a product has FDA-approved labeling describing abuse-deterrent properties does not mean the product is impossible to abuse or that these properties necessarily prevent overdose and death – currently marketed technologies do not effectively deter one of the most common forms of opioid abuse – swallowing a number of intact tablets or capsules. Because opioid medications must in the end be able to deliver the opioid to the patient, there may always be some potential for abuse of these products.

How abuse-deterrent opioids can help with the opioid abuse epidemic
Because AD products with abuse-deterrent properties are expected to reduce abuse compared to non-AD products, the agency is very interested in encouraging and supporting ADFs as part of the FDA’s overarching Opioid Action Plan.

The FDA looks forward to a future in which most or all opioid medications are available in formulations that are less susceptible to abuse than the formulations that lack abuse-deterrent properties. The FDA also supports the efficient development of non-opioid alternatives for treating pain.

All of the companies that have approved brand name opioids with AD properties reflected in their labeling are being required to conduct postmarket studies to determine the impact that AD technologies are having in practice. Having that information is critical, and will allow us to take the next important steps in this area.

How the FDA decides what drugs are considered abuse-deterrent
To meet the FDA’s standards, it is essential that every opioid with labeling describing its AD properties be supported by evidence from in vitro (laboratory) and, where appropriate, in vivo (human) studies. Any communications from the sponsor companies regarding AD properties must be truthful and not misleading (based on a product’s labeling), and supported by sound science taking into consideration the totality of the data for the particular drug. Claims for AD opioid products that are false, misleading, and/or insufficiently proven do not serve the public health.

The FDA has issued two guidances to help industry understand how the agency currently is evaluating these products. These guidances provide the FDA’s recommendations for how the agency evaluates the abuse deterrence of opioids – such as the ability of a drug to deter abuse by snorting or injection:

Opioid medications with FDA-approved labeling describing abuse-deterrent properties
The FDA has approved the following opioids with labeling describing AD properties consistent with the FDA’s Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling:

  • OxyContin
  • Targiniq ER
  • Embeda
  • Hysingla ER
  • MorphaBond
  • Xtampza ER
  • Troxyca ER
  • Arymo ER
  • Vantrela ER
  • RoxyBond

There are no currently approved generic versions of opioids with approved AD labeling.

Page Last Updated: 04/21/2017
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