Monday, April 6, 2015

FDA Issues Final Guidance On The Evaluation and Labeling of Abuse-Deterrent Opioids

U.S. Food and Drug Administration, April 1, 2015

"The U.S. Food and Drug Administration today issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.

Opioid drugs provide significant benefit for patients when used properly; however opioids also carry a risk of misuse, abuse and death. To combat opioid misuse and abuse, the FDA is encouraging manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed, but, for example, may be formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high.

While drugs with abuse-deterrent properties are not 'abuse-proof,' the FDA sees 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." Read More.

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