FDA Approves Labeling With Abuse-Deterrent Features for Extended-Release Opioid Analgesic

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The U.S. Food and Drug Administration (FDA) has approved new labeling for morphine sulfate and naltrexone hydrochloride extended-release capsules. The drug, marketed as Embeda, is an opioid analgesic used to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The drug is the third extended-release opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties. The new labeling includes a claim indicating that oral abuse of the drug may be reduced, though not prevented, when the drug is crushed and taken orally or snorted.

Mode of Administration: Crushed vs Intact

Embeda works by releasing only the morphine in the capsule when taken properly. When crushed, the naltrexone in the drug blocks some of the euphoric effects of the morphine and can precipitate withdrawal in persons dependent on opioids. 

When swallowed intact, however, Embeda can still be abused or misused because the naltrexone is not expected to substantially block the euphoric effects of the morphine. It is unknown whether the abuse-deterrent properties of the agent will result in a reduction in abuse by the intravenous route until additional postmarketing data are available.

Deterring Abuse and Managing Pain Public Priorities

“Preventing prescription opioid abuse and ensuring that patients have access to appropriate treatments for pain are both top public health priorities for the FDA,” said Sharon Hertz, MD, Acting Director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research. “The science behind developing prescription opioids with abuse-deterrent properties is still evolving and these properties will not completely fix the problem. But they can be part of a comprehensive approach to combat the very serious problem of prescription drug abuse in the United States.”

Embeda Part of REMS Program

The FDA is requiring postmarketing studies of Embeda to further assess the effects of the abuse-deterrent features on the risk for abuse of the drug and the consequences of that abuse. In addition, Embeda is part of the Extended Release/Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which requires companies to make available to health-care professionals educational programs on how to safely prescribe these opioid analgesics and to provide medication guides and patient counseling documents containing information on the safe use, storage, and disposal of these agents. 

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