FDA Approves New Abuse-Deterrent Labeling for Opioid Analgesic

The U.S. Food and Drug Administration (FDA) approved new labeling for Embeda, an opioid analgesic to treat severe pain. The new labeling includes a statement indicating that Embeda has properties that are expected to reduce oral abuse of the drug when the product is crushed.

Embeda becomes the third opioid analgesic to be approved with an abuse-deterrent label, in line with the FDA’s 2013 draft guidance, Abuse-Deterrent Opioids – Evaluation and Labeling.

Embeda, which is manufactured by Pfizer, is a combination of morphine sulfate and naltrexone hydrochloride. These agents have competing actions on the opioid receptor; when capsules are swallowed intact, only the morphine is released, producing pain relief but creating the risk of abuse and addiction. When crushed, the naltrexone is also activated, blocking some of the euphoric effects of morphine. This reduces the risk of abuse, though not completely preventing it, for people who improperly use the drug such as by inhaling it.

Though the new labeling is approved, the FDA will require additional postmarketing studies of Embeda to further assess the effects of the abuse-deterrent features on the risk—and consequences—of abuse, particularly in regard to intravenous use. The agency is also holding a public meeting on October 30-31 in Silver Spring, Md., to further discuss the development of abuse-deterrent opioids.

To read about initiatives and recommendations for reducing opioid abuse, see the Psychiatric News article, "Caution Urged for Clinicians Who Prescribe Opioids."