FDA approves abuse deterrent labeling for Pfizer’s Embeda

Embeda is used to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The updated label states that Embeda has properties that are expected to reduce abuse via the oral and intranasal routes when crushed.

The updated label also includes data from a human abuse potential trial of intravenous (IV) morphine and naltrexone to simulate crushed Embeda.

The company said that it is unknown whether the results with simulated crushed Embeda predict a reduction in abuse by the IV route until additional postmarketing data are available.

Embeda capsules consist of extended-release morphine sulfate and sequestered naltrexone hydrochloride, an opioid antagonist and the company intends to introduce the drug in the US in early 2015.

American Academy of Pain Management director of Policy and Advocacy Bob Twillman said prescription opioids are an important treatment option for people with chronic pain.

"However, misuse and abuse of opioids in the US is a serious societal concern, which is why the development of abuse-deterrent formulations of these medicines is a high priority," Twillman said.

"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."