FDA Officials Issue Guidance on Abuse-Deterrent Medications

First App Launched to Identify Drug Shortages
First App Launched to Identify Drug Shortages
The document explains the agency's current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties.

To combat opioid misuse and abuse, officials with the FDA today issued guidance that encourages manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed but may be formulated in a way that makes it difficult to snort or inject.

While drugs with abuse-deterrent properties are not “abuse-proof,” officials with the FDA said in a prepared statement that they view “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 document “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling” explains the agency’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,” FDA Commissioner Margaret A. Hamburg, MD, said in the statement. “We feel this is a key part of combating opioid abuse. We have to work hard with industry to support the development of new formulations that are difficult to abuse but are effective and available when needed.”

In the statement, agency officials said they: “will take a flexible, adaptive approach to the evaluation and labeling of potentially abuse-deterrent products.”

“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,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research said in the statement. “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.”

While this final guidance does not address generic opioid products, agency officials said they understand the importance of available generic options to ensure appropriate access to effective opioid drugs for patients who need them. 

In addition to numerous comments on the draft guidance submitted to the public docket, the FDA convened a public meeting in Oct. 30-31, 2014, to discuss the development, assessment and regulation of abuse-deterrent formulations of opioid medications.