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FDA approves new labeling for extended-release Embeda

The FDA has approved new labeling for an extended-release pain relief combination of morphine sulfate and naltrexone hydrochloride that includes information on potential abuse deterrent properties.

According to a press release from the FDA, the drug combination of morphine sulfate and naltrexone hydrochloride (Embeda, Pfizer) is “expected to reduce, but not totally prevent, abuse of the drug when crushed and taken orally or snorted.” When crushed, naltrexone hydrochloride is expected to block some of the euphoric effects of the morphine sulfate or induce withdrawal in opioid-dependent patients.

“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 the 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.”

When administered orally and intact, however, the combination pain medication can still be misused because the naltrexone hydrochloride is not expected to substantially block the euphoric effects. Effects of intravenous use will be unknown until postmarketing data are available.

The drug combination was initially assessed in a trial of 547 osteoarthritis patients before receiving FDA approval in August 2009.