FDA Offers Final Guidance on Painkillers with Abuse-Deterrent Properties
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moodboard/Thinkstock(NEW YORK) — The U.S. Food and Drug Administration released its “final guidance” on opioid painkillers with potentially abuse-deterrent properties on Wednesday.
In the 29-page report, the FDA aimed to explain its “current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties.” The FDA notes that opioid drugs provide “significant benefit for patients when used properly,” but that the risk of abuse and death are worrisome.
Because of that, the FDA is encouraging manufacturers to develop drugs that work correctly when taken as prescribed, but make it difficult to abuse. “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,” an FDA press release reads.
FDA Commissioner Margaret Hamburg said in a statement that “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.”
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