Embeda Is Back: New Pain Med with Improved Safety

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
Posted on

Embeda is a schedule II extended-release narcotic used for the management of severe pain that requires daily, around-the-clock treatment on a long-term basis. It contains extended-release morphine as well as the abuse deterrent naltrexone.

The new formulation of Embeda has properties that are expected to reduce, but not totally prevent, abuse of the medication. Naltrexone is thought to prevent the euphoric effect of the medication if it is crushed, chewed, or dissolved for snorting or injecting. Naltrexone can also cause withdrawal symptoms in persons addicted to opioids. However, it is unknown if the abuse-deterrent properties of Embeda will significantly decrease abuse until post marketing data is available.

When was Embeda first approved?

The FDA first approved this medication on August 13, 2009.

Why was Embeda withdrawn from the market?

The manufacturer, Pfizer, voluntarily recalled then withdrew Embeda from the market in March 2011 due to concerns regarding stability in the making of the medication.

When will Embeda be available again?

According to the manufacturer, this medication will return to the market in early 2015. Embeda was approved by the FDA on October 17, 2014 as the third extended-release opioid pain reliever with approved labeling for its abuse-deterrent features.

What is the difference between Embeda and current extended-release morphine products?

The new formulation of Embeda contains abuse-deterrent features to help eliminate the potential for abuse when taken by mouth or snorted. In this case, abuse can mean (but isn’t limited to) crushing, snorting, or injecting a medication that is intended for extended-release absorption.

The other extended-release morphine products that are currently available (Avinza, Kadian, MS Contin) DO NOT contain abuse-deterrent features.

How is Embeda taken?
Embeda is available as an extended-release capsule in the following strengths: 20 mg/0.8 mg, 30 mg/1.2 mg, 50 mg/2 mg, 60 mg/2.4 mg, 80 mg/3.2 mg, 100 mg/4 mg.

Embeda is taken every 24 hours and is NOT to be used on an as needed basis.

More information on Embeda:

There is not an official Embeda website at this time, but more information for healthcare professionals can be found here.

Drugs featured in this story

Filed under