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FDA Approves Opvee, a Naloxone Alternative

A new version of medication used to reverse overdoses caused by fentanyl and other opioids was approved by U.S. health regulators on Monday, the Associated Press reports. The medication, Opvee, is similar to naloxone, the life-saving drug that has been used for decades to quickly counter overdoses of heroin, fentanyl, and prescription painkillers. Both work by blocking the effects of opioids in the brain, which can restore normal breathing and blood pressure in people who have recently overdosed. The Food and Drug Administration approved Opvee, a nasal spray update of the drug nalmefene, which was first approved as an injection in the mid-1990s but was taken off the market due to low sales. While naloxone comes as both a nasal spray and an injection, it is not immediately clear how the new drug will be used differently, although researchers see potential in its longer-lasting effects, which may avoid the need to administer multiple doses of naloxone. The drug will be available via prescription and is approved for patients 12 and older.

Scientists at the National Institutes of Health worked with pharmaceutical researchers on a nasal spray version of nalmefene that would quickly resuscitate users, while also protecting them from relapse. “The whole aim of this was to have a medication that would last longer but also reach into the brain very rapidly,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse. Some experts see potential downsides. A side effect of all opioid reversal drugs is that they create intense withdrawal symptoms including nausea, diarrhea, muscle cramps, and anxiety. With naloxone, those symptoms might last 30 to 40 minutes. Dr. Lewis Nelson of Rutgers University says nalmefene can cause problems that last six hours or more, requiring extra treatment and management by health professionals. “The risk of long-lasting withdrawal is very real and we try to avoid it,” said Nelson, an emergency medicine physician and former adviser to the FDA on opioids. He said it’s easy enough to give a second or third dose of naloxone if it wears off. “We’re not suffering from a naloxone shortage where we need to use an alternative,” he said. “We have plenty of it and it works perfectly well.” The FDA approval comes as drug overdose deaths increased slightly last year with more than 109,000 fatal overdoses recorded in 2022, according to the latest figures from the Centers for Disease Control and Prevention.


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