Opioid Embeda: FDA Abuse-Deterrent Label Approval

embedaDeveloping narcotic opioids that are hard to abuse is of the utmost importance when considering the gravity of the prescription drug epidemic in America. It is often the case that drugs, whose makers claim as having abuse-deterrent features, lack sufficient properties for deterring abuse; addicts find ingenious ways of getting around the obstacles that pharmaceutical companies create in their drugs.

One of the more novel opioid drugs containing abuse-deterrent features is Embeda (morphine sulfate/naltrexone hydrochloride). The drug is a combination of an opioid and an opioid antagonist. What makes the drug unique is that when used correctly it treats chronic severe pain; however, if the drug is crushed for the purpose of injecting or snorting, the naltrexone is released, blocking some of the euphoric effects of the morphine. In some cases the naltrexone can cause withdrawal in people who are dependent on opioids, according to a FDA news release.

Embeda’s new labeling, which states the drug has abuse-deterrent features when crushed, has received approval from the Food and Drug Administration (FDA), the Associated Press reports.

Embeda is only one of three opioid analgesics to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance, Abuse-Deterrent Opioids – Evaluation and Labeling.

It is not known if the abuse-deterrent properties of Embeda will lead to a reduction in people abusing the drug intravenously, the FDA notes. The drug can still be misused if it is swallowed intact.

“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.”