Friday, July 20, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

One of the ways that the U.S. Food and Drug Administration is working to address the opioid epidemic is by encouraging the development of opioid analgesic products that are harder to manipulate and abuse. Opioids with abuse-deterrent formulations (ADFs) are intended to make certain types of abuse, such as crushing a tablet to snort or dissolving a capsule to inject, more difficult or less rewarding. 

These innovative formulations are designed to make it harder for people to manipulate the opioid product so they can’t be as easily abused to deliver an immediate “high.” But it’s important that prescribers and patients understand that these drugs are not “abuse-proof,” and they do not prevent addiction, overdose or death.

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