FDA Approves Opioid's New Abuse Deterrent Labeling

Caroline Cassels

October 21, 2014

The US Food and Drug Administration (FDA) has approved updated labeling for the opioid analgesic, morphine sulfate‒naltrexone hydrochloride (Embeda, Pfizer Inc).

According to the FDA, the medication has properties that are expected to reduce, but not totally prevent, abuse of the drug when crushed and taken orally or snorted.

It works by releasing the morphine in the capsule when taken as directed. When crushed, the naltrexone in the drug blocks some of the euphoric effects of the morphine and can precipitate withdrawal in opioid-dependent individuals.

However, the FDA notes that even when swallowed intact, Embeda can still be abused or misused because the naltrexone is not expected to substantially block the euphoric effects of the morphine.

In addition, the FDA points out that abuse or misuse of the drug can still cause overdose that may result in death. If abused, it can also cause withdrawal in people who are dependent on, or tolerant to, opioids.

The FDA points out that it is not yet known whether the abuse-deterrent properties of Embeda will reduce intravenous drug abuse. This question will only be answered by additional postmarketing studies requested by the FDA.

"Preventing prescription opioid abuse and ensuring that patients have access to appropriate treatments for pain are both top public health priorities for the FDA," Sharon Hertz, MD, acting director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA's Center for Drug Evaluation and Research, said in a release.

"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 US," she added.

First approved in 2009, Embeda was voluntarily withdrawn from the market in March 2011, owing to testing that revealed stability concerns in the manufacturing process. The FDA confirmed that these issues were resolved with its approval of a manufacturing supplement in November 2013.

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