FDA Approves Abuse-Deterrent Labeling for New Pain Medication Embeda

FDA Approves Abuse-Deterrent Labeling for New Pain Medication Embeda
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October 21, 2014

The U.S. Food and Drug Administration (FDA) has approved new labeling for a pain medication with abuse-deterrent properties.

Embeda, a morphine-based opioid, is the third medication of this type to be approved with a label describing the product's abuse deterrent properties. The new labeling includes a claim indicating that Embeda has properties that are expected to reduce oral abuse when the product is crushed.

The drug only works by releasing the morphine in the capsule when it is taken properly. Those who abuse pain medications of this type may swallow or snort a crushed pill for a faster high. When crushed, the naltrexone in Embeda blocks some of these euphoric affects, which may help reduce the instances when it is abused or misused.

That doesn't mean the drug isn't addictive. Users can still become addicted to the drug when it is taken properly. Given its risk for addiction, Embeda isn't approved for as-needed pain relief and is only prescribed when all other pain management options have been exhausted.

It also isn't clear if the deterrent properties would work if the drug was used intravenously.

Embeda, which is made by Pfizer, was first approved in 2009, but was voluntarily withdrawn from the market in March 2011, due to testing that found stability concerns in the manufacturing process. The FDA confirmed that these issues were resolved with its approval of a manufacturing supplement in November 2013.

The FDA is requiring postmarketing studies of the drug to further assess the effects of the abuse-deterrent features on the risk for abuse and the consequences of that abuse. Pfizer anticipates the drug coming back to the market early 2015.