FDA approves updated label for Pfizer's Embeda

NEW YORK — Pfizer last week announced that the Food and Drug Administration approved a revised label for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release capsules, for oral use, CII, to include abuse-deterrence studies. 

 

The revised label states that the drug has properties expected to curb abuse via oral and intranasal routes when crushed, though abuse of the drug is still possible. The updated label also incorporates data from a human abuse potential study of intravenous (IV) morphine and naltrexone to simulate crushed Embeda, the company stated. 

 

Embeda is indicated for treatment for pain that is severe enough to require daily, long-term opioid treatment when alternative treatment plans have proven inadequate. Pfizer said it expects the drug to be available in the United States in early 2015.

 

 

“Prescription opioids are an important treatment option for people with chronic pain. However, misuse and abuse of opioids in the U.S. is a serious societal concern, which is why the development of abuse-deterrent formulations of these medicines is a high priority,” said Bob Twillman, Ph.D.,director of policy and advocacy, American Academy of Pain Management. “All opioid medications, including morphine products, have the potential for abuse. We believe that anything that can be done to reduce this risk is a significant development for healthcare providers and their patients.”

 

From 1999 to 2010, the number of fatal overdoses involving prescription painkillers quadrupled, with more than 16,000 deaths in 2010, according to the Centers for Disease Control and Prevention. In 2012, the National Survey on Drug Use and Health showed that more than 12 million people in the United States used prescription painkillers for non-medical purposes in the previous year. Seventy percent of those using non-medical prescription opioids got them from a friend or relative. 

 

“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,” said Dr. Steven Romano, SVP and head, Medicines Development Group, Pfizer Global Innovative Pharmaceutical Business. “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.”