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New Painkiller Joins the Abuse-Deterrent Club
An extended-release opioid painkiller has gained Food and Drug Administration approval to have an abuse-deterrent label, making it the third narcotic painkiller on the market to have this distinction.
Embeda, the brainchild of pharmaceutical giant Pfizer, consists of an extended-release morphine sulfate that is combined with an opioid antagonist in the form of sequestered naltrexone hydrochloride. The painkiller will be available in the U.S. early next year and is meant to help manage severe pain that requires daily, around-the-clock opioid treatment after a series of alternative treatment options have proven inadequate.
The Deterrent Theory
It’s Embeda’s combination of morphine and naltrexone that led to the FDA’s approval of an abuse-deterrent label. Data on the drug combo shows that morphine/naltrexone properties lower its abuse potential. Crushing the medication allows the naltrexone to block some of the euphoric effects that opioid abusers seek, but Embeda can be still abused if it’s swallowed whole.
The abuse-deterrent features will also be further assessed in post-marketing studies that are set to be conducted sometime during 2015. The abuse-deterrent label for Embeda has been more than four years in the making. It was initially launched on the market August 2009, but then voluntarily withdrawn by Pfizer in 2011 due to stability concerns. After further calculations, Pfizer reintroduced Embeda last November.
What’s in a Label?
Having Embeda classified as abuse-deterrent is crucial, given that opioid abuse has become a major problem in the U.S. over the last 15 years.
Opioid overdose deaths quadrupled between 1999 and 2011, with the greatest increase in deaths occurring among people between ages 55 and 65. Emergency room visits related to prescription drugs also doubled during that time among patients in this age range.
The National Institute of Drug Abuse also reported last April that more than five million Americans abuse narcotic painkillers each year.
“There’s this growing group of seniors, they have pain, they have anxiety … and a lot of (doctors) have one thing in their tool box – a prescription pad,” said Mel Pohl, director of the Las Vegas Recovery Center. “The doctor wants to make their life better, so they start on the meds.”
The Future for Naltrexone
Naltrexone could also be used in combination with other medications to help treat addiction. An August 2012 study published in Science Transitional Medicine found that combining this opioid antagonist with buprenorphine could help treat cocaine addiction. Naltrexone has also been used with moderate success in treating alcoholism and is even being researched as a potential cure for problem gambling.
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