On October 28, 2016, Douglas C. Throckmorton, M.D., of the FDA’s Center for Drug Evaluation and Research said the FDA is working to be part of the solution to the opioid abuse epidemic, but there is no single solution to this complex problem. The agency is encouraging efforts to develop new opioid formulations with abuse-deterrent properties that make it harder to abuse these powerful medications. Opioids with abuse-deterrent properties are tablets or capsules that are designed to deter abusers from crushing them into a powder for swallowing, snorting, or injecting to create a faster, more intense high.
Knowing there are some 100 million Americans with significant pain each year, the FDA wants to help ensure that patients in need continue to have appropriate access to pain medications, including opioids. At the same time, they must work to ensure that these powerful medications are used as safely as possible.
To date, the FDA has approved seven opioid formulations with abuse-deterrent properties consistent with FDA guidance, and there are more in the development pipeline. 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.
Each manufacturer has its own proprietary technology for deterring abuse. Some abuse-deterrent formulations consist of tablets with a hardened surface that is difficult to crush and some turn the crushed medicine into a gooey substance that is difficult to inject. Other current approaches combine the opioid with naloxone or naltrexone, drugs that block the effects of the opioid in the body that are activated when the opioid is crushed. Additional approaches are currently under development.
The FDA has approved seven extended-release/long-acting (ER/LA) opioids with labeling describing abuse-deterrent properties consistent with the FDA’s Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling. They are OxyContin, Targiniq ER, Embeda, Hysingla ER, MorphaBond, Xtampza ER, and Troxyca ER. As a result of the FDA’s review, FDA-approved product “labeling” (prescribing information) for these medications clearly states the product’s abuse-deterrent properties. All of the companies that have approved brand name opioids with abuse-deterrent properties reflected in their labeling are being required to conduct postmarket studies to determine the impact that abuse-deterrent technologies are having in practice. Having that information is critical, and will allow the FDA to take the next important steps in this area.
There are currently no immediate-release opioids with FDA-approved abuse-deterrent labeling consistent with the 2015 guidance for the industry. There also are no currently approved generic versions of opioids with approved abuse-deterrent labeling.
Other manufacturers have chosen to add what they may intend as abuse-deterrent properties to their product, but the FDA has not seen sufficient evidence that these properties are effective. Therefore, the FDA-approved labeling for these products does not identify them as having abuse-deterrent properties.
Dr. Throckmorton noted that it is important to recognize that the FDA refers to these drugs as “abuse-deterrent” not abuse-proof. There will always be some potential for abuse of these products. For instance, a patient can orally ingest a quantity beyond what is prescribed. It is also true that people intent on abusing an opioid may find ways to overcome the abuse-deterrent properties of the drug that were not identified during premarketing research.
The FDA has issued two guidances to help the 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:
The FDA is encouraging the development of opioid formulations with abuse-deterrent properties to help combat the opioid abuse epidemic. 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 the industry, the FDA is taking a flexible, adaptive approach to the evaluation and labeling of potentially abuse-deterrent products. In addition, the FDA recently announced it would help fund the development of assessment tools to evaluate packaging, storage, delivery, and disposal solutions designed to prevent or deter misuse and abuse of opioid analgesics.
Support for abuse deterrent formulations is one important part of a strategy to help prescribers and patients make the best possible choices about how to use these powerful drugs. The goal is to find the balance between appropriate access to opioids for patients in pain and the need to reduce abuse and misuse of these medications.
See the FDA Voice Post
Also see the FDA Announcement
See also Medical Law Perspectives June 2014 Report: Physician and Manufacturer Risks for Pain Pump Injuries: Malpractice, Negligence, and Products Liability
See also Medical Law Perspectives, January 2014 Report: Prescription Painkillers: Risks for Patients, Pharmacists, and Physicians
See also Medical Law Perspectives May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See the Medical Law Perspectives October 8, 2014, Blog: Opioid Pain Pill Abusers Switch to Heroin; Heroin Overdose Deaths Double