WASHINGTON — U.S. health regulators on Monday approved a new, easy-to-use version of a drug to reverse overdoses caused by fentanyl and other opioids at the root of the nation’s drug crisis.
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 has approved Opvee, an update to the nasal spray drug nalmefene, which was first approved as an injection in the mid-1990s but later pulled from the market due to poor sales. Naloxone comes as a nasal spray and injection.
It’s not immediately clear how the new drug will be used differently compared to naloxone, and some experts see potential downsides to its longer-acting effect. The drug will be available by prescription and is approved for patients 12 years and older.
In federally funded studies, Opvee achieved similar recovery results to Narcan, the leading brand of naloxone nasal spray.
Opvee was developed by Opiant Pharmaceuticals, which was recently acquired by rival Indivior, maker of several drugs for opioid addiction. Indivior plans to launch Opvee in October at the earliest.
As the opioid epidemic shifted toward fentanyl and other synthetic opioids, researchers in the pharmaceutical industry and the US government saw a new role for the drug.
Because fentanyl stays in the body longer than heroin and other opioids, some people may need multiple doses of naloxone over several hours to completely reverse an overdose.
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Scientists from the National Institutes of Health worked with pharmaceutical researchers on a nasal spray version of nalmefene that would quickly resuscitate users, while protecting them from relapses. The testing and development was funded by more than $18 million in grants from the US government’s Biomedical Advanced Research and Development Authority and the NIH, which also helped design the studies.
“The goal was to have a drug that would last longer but also get to the brain very quickly,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse.
Still, some experts see potential downsides.
A side effect of all opioid reversal medications is that they create intense withdrawal symptoms, including nausea, diarrhea, muscle cramps, and anxiety. With naloxone, these symptoms can last 30 to 40 minutes.
Dr. Lewis Nelson of Rutgers University says these problems can last for six hours or more on nalmefene, requiring further treatment and support from medical professionals.
“The risk of long-term withdrawal is very real and we’re trying to avoid it,” said Nelson, an emergency physician and former FDA adviser on opioids.
Nelson said it was easy enough to give a second or third dose of naloxone if it wore off.
“We don’t have a naloxone shortage where we have to use an alternative,” he said. “We have a lot of it and it works perfectly well.”
The FDA approval comes as drug overdose deaths rose slightly last year after two big leaps during the pandemic. More than 109,000 fatal overdoses were recorded in 2022, according to the latest figures from the Centers for Disease Control and Prevention.
More than two-thirds of those deaths were linked to fentanyl and other synthetic opioids, which have largely replaced heroin and prescription opioids.
Naloxone has long been at the center of government efforts to address the overdose crisis at the federal and local levels. Police, firefighters and other first responders regularly transport the drugs. And officials in all 50 states have ordered pharmacists to sell or dispense the drug without a prescription to anyone who wants it.
In the latest federal push, the FDA recently approved Narcan for sale over the counter. The change will allow the new version of the drug to be stocked in grocery stores, vending machines and other retail outlets. The nasal spray, which includes updated instructions for regular users, is set to launch this summer. Emergent Biosolutions has yet to announce pricing for the over-the-counter version.
Indivior said he was still considering billing for his medication. It will compete in the same market as naloxone, where most buyers are local governments and community groups who distribute to first responders and people at risk of overdose. Indivior told investors that Opvee could eventually generate annual sales of between $150 million and $250 million.
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