FDA Moves to Encourage Production of Abuse-Deterrent Opiates


To fight back against the opioid abuse "epidemic," the FDA is working toward production standards for opiate painkillers that resist being crushed or dissolved for the purpose of intentional abuse.

As a fresh approach to the problem of opioid misuse, the FDA has issued draft guidance for the pharmaceutical industry on production of abuse-deterrent opioids. These are formulations that cannot easily be crushed or dissolved for the purpose of "snorting" or injection.

The science of abuse deterrence is rapidly evolving, according to the FDA. The Agency is working with industry to refine formulation technologies and methods for evaluating them.

“Our nation is in the midst of a prescription drug abuse epidemic,” said Gil Kerlikowske, director of National Drug Control Policy in an FDA press release. “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."

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