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FDA publishes guidance on abuse-resistant opioids

Published on 14/01/13 at 02:35pm
FDA Hamburg image
FDA Commissioner Margaret Hamburg

The US Food and Drug Administration has issued draft guidance designed to combat the escalating problem of abuse of prescription opioid analgesics.

The aim of the new document - which is open for comment until early March - is to help firms develop new formulations of opioids with abuse-deterrent properties, which the agency says is ‘a high public health priority’.

The guidance defines what the FDA considers abuse-resistant properties, including physical or chemical barriers to prevent doses being crushed or ground up, novel delivery systems, the incorporation of antagonists to block the effects sought by medicine abusers, or substances that make taking them in excess unpleasant.

The guide also outlines the studies that would need to be carried out on these products and gives insight into how the FDA will review them. Last year, the agency also unveiled a new risk evaluation and mitigation strategy (REMS) policy for opioids.

The agency's move comes just a few weeks after pharma company Zogenix failed to convince an FDA advisory committee that its Zohydro (hydrocodone) product should be approved for marketing, amid concerns about its potential for abuse by those addicted to opioid painkillers.

The US Centers for Disease Control and Prevention (CDC) has classified opioid abuse as epidemic, on the increase even as use of illicit drugs such as methamphetamine and cocaine appears to be declining.

Data from the National Survey on Drug Use and Health indicates that around 70% of abusers procure them from friends or relatives, with only 5% or so obtaining them from a drug dealer or another illegal source, such as over the internet.

"The FDA is extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation", commented FDA Commissioner Margaret Hamburg. 

"This draft guidance is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse".

The FDA plans to hold a public meeting in February to discuss the new guidance and other issues related to the development of opioid analgesics.

Phil Taylor

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