New Label for Opioid Painkiller Embeda Will Say Drug Has Abuse-Deterrent Features

The Food and Drug Administration (FDA) has approved new labeling for the opioid painkiller Embeda that states the drug has abuse-deterrent features, the Associated Press reports.

The label will indicate Embeda has properties expected to reduce abuse of the drug when it is crushed and taken orally or snorted, the article notes. The drug can still be misused if it is swallowed intact.

Embeda contains morphine and naltrexone, and comes in extended-release capsules. It is approved to treat pain that is severe enough to require daily, around-the-clock, long-term opioid treatment, and for which other treatment options are not sufficient, according to a FDA news release. When taken properly, the drug releases only the morphine in the capsule. When the capsule is crushed, the naltrexone blocks some of the euphoric effects of the morphine, and can cause withdrawal in people who are dependent on opioids.

The FDA noted it is not known whether the abuse-deterrent properties of the drug will lead to a reduction in people who abuse the drug intravenously.

“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 U.S.”

The FDA is requiring Pfizer to conduct postmarketing studies of Embeda to further assess the effects of the abuse-deterrent features of the drug.