FDA Approves New Nasal Spray for Opioid Overdose Reversal

WASHINGTON — U.S. health officials on Monday approved a new, easy-to-use version of a drug to reverse fentanyl and other opioid overdoses that are fueling the country’s drug crisis.

Opvee is similar to naloxone, the life-saving drug used for decades to rapidly combat heroin, fentanyl, and prescription painkiller overdoses. Both work by blocking the effects of opioids in the brain, which can lead to normal breathing and blood pressure in people who have recently overdosed.

The Food and Drug Administration endorsed Opvee, a nasal spray update of the drug nalmefene, which was first approved for injection in the mid-1990s but was later withdrawn due to poor sales. Naloxone is available both as a nasal spray and as an injection.

It’s not immediately clear how the new drug will be used differently compared to naloxone, and some experts see potential downsides in its longer-acting effects. The drug will require a prescription and is approved for patients ages 12 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 competitor Indivior, a maker of several opioid addiction drugs. Indivior expects to launch Opvee in October at the earliest.

As the opioid epidemic has shifted to 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 fully reverse an overdose.

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Scientists at the National Institutes of Health worked with pharmaceutical researchers on a nasal spray version of nalmefene that would quickly revive users while protecting them from relapse. 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 whole goal was to have a drug that would last longer but also get into 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 drugs is that they produce severe withdrawal symptoms, such as nausea, diarrhea, muscle spasms, and anxiety. With naloxone, these symptoms can last 30 to 40 minutes.

dr Lewis Nelson of Rutgers University says these problems can last six hours or more on nalmefene and require additional treatment and attention from healthcare professionals.

“The risk of prolonged withdrawal is very real and we’re trying to avoid it,” said Nelson, an emergency room physician and former FDA opioid adviser.

Nelson said it’s easy to give a second or third dose of naloxone when the effects wear off.

“We don’t have a naloxone deficiency where we have to resort to an alternative,” he said. “We have plenty of it and it works perfectly.”

The FDA approval comes at a time when the number of drug overdose deaths has increased slightly over the past year after two big jumps during the pandemic. According to the latest figures from the Centers for Disease Control and Prevention, more than 109,000 fatal overdoses were recorded in 2022.

More than two-thirds of those deaths were related to fentanyl and other synthetic opioids, which have largely replaced heroin and prescription opioids.

Naloxone has long been the focus of government efforts to address the federal and local overdose crisis. Police, firefighters and other first responders routinely carry the drug with them. And officials in all 50 states have ordered pharmacists to sell or dispense the drug without a prescription to anyone who wants it.

As part of a recent federal initiative, 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 expected to launch this summer. Emergent Biosolutions has not yet announced a price for the over-the-counter version.

Indivior said it is still considering what to charge for its drug. It will compete in the same market as naloxone, where most buyers are local governments and community groups, who distribute the drugs to first responders and people at risk of overdose. Indivior has told investors that Opvee could ultimately generate between $150 million and $250 million in annual sales.

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