FDA issues Final Guidance on Abuse-Resistant Painkillers

This week, the FDA released long-awaited final guidance on opioid painkillers with abuse-deterrent properties, which are designed to reduce the risk of overdoses and deaths associated with inappropriate use of the powerful drugs.  

The agency is focused on encouraging and assisting drug manufacturers in developing opioid drugs, like Oxycontin and Vicodin, with abuse-deterrent properties that are effective and work correctly when taken as prescribed.

The FDA document, Guidance for Industry: Abuse-Deterrent Opioids -Evaluation and Labeling, provides information on how the FDA plans to help bring new abuse-deterrent opioid drugs to market, amid rising concerns of opioid painkiller abuse.

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The guidance comes more than a year after the agency first introduced a  draft guidance version in 2013. The draft consisted of proposed recommendations concerning opioid painkillers.

The agency acknowledges that prescription drugs with abuse-deterrent properties are not “abuse-proof,” however, the guidance is an important step in the process “toward balancing appropriate access to opioids for patients with pain with the importance of reducing opioid misuse and abuse.”

The FDA calls on manufacturers to formulate abuse-deterrent drugs in a way that deters misuse and abuse, including making it more difficult for a drug to be crushed and snorted or injected for users to gain a more intense high.

As part of the new guidance, the FDA indicates that it plans to support drugs makers and potential advancements in abuse-deterrent drugs. They also plan to help manufacturers navigate the regulatory path to market new abuse-deterrent drugs as quickly as possible, making “flexible, adaptive approach to evaluation and labeling.”

“The science of abuse-deterrent medication is rapidly evolving, and the FDA is eager to engage with manufacturers to help make these medications available to patients who need them,” said FDA Commissioner Margaret A. Hamburg, M.D. “We feel this is a key part of combating opioid abuse. We have to work hard with industry to support the development of new formulations that are difficult to abuse but are effective and available when needed.”

The document also focused on the studies needed to show a particular drug formulation has abuse-deterrent properties. It will make recommendations on how those future studies should be performed and evaluated and what labeling claims may be approved based on the results of the studies.

Painkiller Abuse Concerns

In 2012, the U.S. Centers for Disease Control and Prevention (CDC)  reported that there were about 27,000 unintentional prescription drug overdose deaths in the United States. The CDC declared the problem, which was killing more people than illegal drugs, an epidemic.

In response to implementation of local and national intervention programs over the past 15 years, research indicates abuse of narcotic painkillers may now be on the decline. The study first recorded a significant increase before finally seeing a decline in opioid narcotic abuse from 2011 to 2013

In an effort to address increasing opioid drug abuse, the FDA issued proposed drug labeling changes in 2013, that called for stronger warnings and safety language on extended release and long acting opioid painkillers.

Prescription opioid painkillers can provide patients with significant relief of pain when used properly; however the drugs also carry a high risk of misuse, abuse and death. The FDA plans to continue their effort to work to help prescribers and patients make best possible choices about how to use powerful drugs.

The guidance is solely for brand name opioid drugs, not generic drugs. The FDA is continuing its effort to draft a final guidance for generic abuse-deterrent opioid painkillers to ensure patients have “appropriate access” to effective drugs for patient who need them.


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