The Food and Drug Administration (FDA) is cracking down on manufacturers who have opioid drugs in the works. The agency has drafted new guidelines for approving new opioids that include what studies should be conducted to demonstrate that a given formulation has abuse-deterrent properties, how those studies will be evaluated by the agency, and what labeling claims may be approved based on the results of those studies.
The new recommendation, entitled “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling,” is part of a larger effort on the FDA’s part to prevent prescription drug abuse and misuse.
Opioids are powerful painkillers that can alleviate pain but also give feelings of euphoria. The drugs can be abused in a number of ways. Abuse-deterrent formulations target the known or expected routes of abuse such as crushing on order to snort or dissolving in order to inject, for the specific opioid drug substance in that formulation.
The science behind making a drug abuse-deterrent is still relatively new, and the formulation technologies and the analytical, clinical and statistical methods for evaluating those technologies are quickly evolving. The FDA says it will take a flexible, adaptive approach to the evaluation and labeling of drugs designed to be abuse-deterrent.
“Our nation is in the midst of a prescription drug abuse epidemic,” said Gil Kerlikowske, director of National Drug Control Policy. “While there are no silver bullet solutions to this public health and safety challenge, abuse-deterrent formulations of powerful prescription opioids can make a difference in addressing this epidemic.”