Abuse-Deterrent Guidelines Issued by FDA
In releasing the guidelines, the Food and Drug Administration (FDA) emphasized the benefits and potential risks of opioid medications.Opioid drugs provide significant benefit for patients when used properly; however opioids also carry a risk of misuse, abuse and death," noted the agency in a press release.
To combat opioid misuse and abuse, the FDA has been encouraging manufacturers to develop abuse-deterrent drugs. The science of abuse-deterrent technology is still relatively new and evolving. The idea is to allow an opioid to work correctly when taken as prescribed, but it is 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.
Guidance for Industry
The document “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling” explains the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. 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 science of abuse-deterrent medication is rapidly evolving, and the FDA is eager to engage with manufacturers to help make these medications available to patients who need them,” said FDA Commissioner Margaret A. Hamburg, MD.
“Development of abuse-deterrent products is a priority for the FDA, and we hope this guidance will lead to more approved drugs with meaningful abuse-deterrent properties,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “While abuse-deterrent formulations do not make an opioid impossible to abuse and cannot wholly prevent overdose and death, they are an important part of the effort to reduce opioid misuse and abuse.”
Already Available Products
The abuse-deterrent formulations on the market are designed in one of several ways, noted Lynn Webster, MD, in an interview with Practical Pain Management. "One technology makes it difficult for people to crush or dissolve opioid pills (such as OxyContin, Hysingla) to snort or inject the drug. Another technology uses an opioid antagonist (naloxone in the ER/LA opioid Targiniq and naltrexone in Embeda) that is released if the product is crushed, making the opioid ineffective if it is ingested, snorted, or injected. When taken properly, the drug releases only the opioid in the capsule. However, when the capsule is crushed, the opioid antagonist is released, blocking some of the euphoric effects of the opioid and possibly causing withdrawal in people who are dependent on opioids," noted Dr. Webster, Vice President of Scientific Affairs at PRA Health Sciences and Past President of the American Academy of Pain Medicine (AAPM).
The final guidance is intended to assist drug makers who wish to develop opioid drug products with potentially abuse-deterrent properties. 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 will take a flexible, adaptive approach to the evaluation and labeling of potentially abuse-deterrent products.
While this final guidance does not address generic opioid products, the agency understands the importance of available generic options to ensure appropriate access to effective opioid drugs for patients who need them. The FDA is committed to supporting the development and use of generic drugs that have abuse-deterrent properties and is working on draft guidance in this area.