FDA Approves Label for Embeda to Deter Abuse


The FDA recently announced it approves a new label designed for the prescription medication Embeda to deter potential abuse. Embeda is a continuous opioid analgesic, in extended release capsules, used to treat severe pain that is unmanageable with other forms of treatment. Embeda is not designed for as-needed pain relief. Embeda is the third prescription so far to receive the new label.

The new label claims that the properties in Embeda are expected to reduce oral abuse when the pills are crushed or snorted, but acknowledges that medication abuse cannot be totally prevented. Here’s how it works. The morphine inside Embeda is designed to only be released when the medication is taken properly. When crushed, the opioid receptor antagonist agent naltrexone hydrochloride activates to block some of the morphine’s euphoric effects. If a person addicted to opiates takes the medication improperly, it can induce withdrawal symptoms for that person.

The FDA first approved Embeda in 2009. However, it was voluntarily withdrawn after stability concerns in the manufacturing process were discovered. Pfizer finally able to fix those issues in 2013. Pfizer does expect that Embeda will be available in the United States in the early part of 2015. The most common side effects that occur from taking Embeda include nausea, vomiting, constipation, headache, dizziness, and drowsiness.

Embeda can still be abused if taken intact because the naltrexone agent is not expected to activate under those circumstances. There is no known data yet on the reduction of abuse if Embeda is taken intravenously. If Embeda is abused by any of the above routes, it can result in overdose leading to death. The FDA label to deter abuse was approved as the beginning of further research to understand how to make this process better.

Bob Twillman is the Director of Policy and Advocacy for the American Academy of Pain Management. He recently stated that prescription opioid medication is a vital treatment option for those with chronic pain. However, misuse and abuse of these powerful medications is a serious concern for society and it must be addressed. He believes that developing these abuse-deterring medications should be a high priority.

Over 16, 000 fatal overdoses alone occurred involving prescription opiates in 2010, according to statistics from the Centers for Disease Control and Prevention. The National Survey on Drug Use and Health reported over 12 million individuals used prescription opioids for non-medical purposes in the United States in 2012. Around 70 percent of these non-medical opiate users acquired the medication from friends and family.

Sharon Hertz, M.D. is the acting director for the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research. She stated that the science behind developing prescription opioid medication that contains abuse-deterring properties is still growing and admits that these properties will not solve the problem completely.  However, the FDA approval for the abuse-deterring Embeda can be a smaller part of a more comprehensive approach in fighting prescription drug abuse in the United States.

By Valerie Bordeau



Business Wire

 American News Report

Photo by: Flickr



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