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FDA advises how to manufacture abuse-resistant pain drugs

NEWS IN BRIEF — Posted Jan. 21, 2013

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The Food and Drug Administration on Jan. 9 issued a proposal to help the pharmaceutical industry develop new formulations of opioids with abuse-deterrent properties.

The FDA document explains the agency’s views on the types of studies that should be conducted to demonstrate that a formulation can curb abuse, and it tells how the agency will evaluate those studies. The draft guidance also highlights the kinds of labeling claims that can be approved based on the study results (link). The agency was required to issue the proposed guidance under the FDA Safety and Innovation Act of 2012.

Opioids contribute to an estimated 15,000 U.S. deaths and more than 340,000 emergency department visits annually, according to the Centers for Disease Control and Prevention.

Abuse-deterrent formulations target the known or expected routes of drug abuse for a particular opioid substance in a pain medication, the FDA said. Routes of drug abuse include crushing a pill to snort it and dissolving a pill so it can be injected. Because the science of abuse deterrence is relatively new, the FDA said it will take a flexible, adaptive approach to the evaluation and labeling of potentially abuse-deterrent products.

The agency is seeking public comment on the draft for 60 days (link). It will consider information received from the public when it finalizes the document.

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