FDA Allows Abuse Deterrent Label Update For Pfizer's Embeda

Pfizer reported that the U.S. Food and Drug Administration (FDA) has approved its application to update the label of its oral painkiller, Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, to include abuse-deterrence studies.

Embeda capsules contain extended-release morphine sulfate and opioid antagonist sequestered naltrexone hydrochloride. The drug helps patients that are suffering from severe, long-term pain that have not found opioid treatment effective.

The update states that Embeda has properties that can reduce abuse of the drug, should it be crushed and taken orally or through the intranasal routes. The label expansion also includes data from a human abuse potential study of a simulation of crushed Embeda. The company clarifies however, that though it has abuse-deterrent properties, the drug can still be abused either orally or through snorting the drug.

Dr. Steven Romano, SVP and head of Medicines Development Group at Pfizer Global Innovative Pharmaceutical Business, said, “More than one-third of extended-release opioids prescribed are morphine, and Embeda is the first extended-release morphine with the potential to reduce abuse via the oral and intranasal routes when crushed. Pfizer believes that abuse-deterrent products, like Embeda, are important to help address the growing public health problem of opioid abuse in the U.S.” Pfizer has received a Prior Approval Supplement for the drug in 2013, more than two years after it voluntarily recalled Embeda in 2011 due to a pre-specified stability requirement.

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

Pfizer said it anticipates releasing Embeda in the U.S. early next year.