New nasal spray aimed at reversing fentanyl overdoses is now approved

The drug lasts longer than Narcan, with similar effectiveness.

The FDA has approved a new nasal spray to reverse opioid overdoses, particularly those caused by fentanyl.

The spray, called Opvee, is a new delivery vehicle for nalmefene, a drug that was approved in the 1990s in injectable form but was pulled from the market due to low sales, the AP reported. It was approved for use in patients 12 and older as an emergency medication for people suffering an opioid overdose.

The approval “places a new prescription opioid reversal option in the hands of communities, harm reduction groups and emergency responders,” FDA commissioner Robert M. Califf said. The news comes a couple months after the regulatory body approved an over-the-counter version of naloxone nasal spray, also known as Narcan.

The newly approved spray, called Opvee, is approved for patients 12 and over suffering an opioid overdose.

Both drugs work by essentially blocking opioids effects in the brain, restoring victims’ breathing and blood pressure.

In clinical trials, nasal spray nalmefene matched Narcan in performance, FiercePharma reported, prompting the drug’s maker, Indivior, to apply for approval and secure a fast-track designation. Indivior also makes the opioid treatment drug Suboxone. 

Nalmefene vs. Narcan: After two massive leaps during the pandemic, US opioid overdose deaths again ticked up slightly in 2022, the AP reported, with over 109,000 deaths.

Fentanyl and other synthetic opioids now make up the lion’s share of overdose deaths, which has inspired a new look at nalmefene. Fentanyl stays in the body longer than heroin or other opioids, meaning multiple doses of Narcan may be needed to reverse the overdose — so researchers looked to develop an overdose spray potentially better suited to the synthetic opioids.

“The whole aim of this was to have a medication that would last longer but also reach into the brain very rapidly,” Nora Volkow, director of the National Institute on Drug Abuse, told the AP. 

But opioid reversal drugs can cause an especially nasty side effect: the rapid onset of withdrawal symptoms like nausea, cramps, and anxiety. Obviously, saving a life is more important than withdrawal, but especially prolonged symptoms may make doctors reluctant to use this treatment instead of Narcan.

Fentanyl stays in the body longer than heroin or other opioids, meaning multiple doses of Narcan may be needed — so researchers developed Opvee to be potentially better suited to the synthetic opioids.

Whereas Narcan may cause these effects to last for a half hour or so, nalmefene — because it is longer lasting — could extend the unpleasantry for six hours or more, Rutgers University emergency medical physician Lewis Nelson told the AP. That means extra treatment from already-strapped healthcare providers.

“The risk of long-lasting withdrawal is very real and we try to avoid it,” Nelson, who used to advise the FDA on opioids, told the AP. “We’re not suffering from a naloxone shortage where we need to use an alternative. We have plenty of it and it works perfectly well.”

Indivior plans to roll out Opvee in October at the earliest. 

We’d love to hear from you! If you have a comment about this article or if you have a tip for a future Freethink story, please email us at [email protected].

Psychedelic drugs and the law: What’s next?
The push to legalize magic mushrooms, MDMA, LSD, and other hallucinogens is likely to heighten tensions between state and federal law.
A dietician explains “Zepbound,” the newest weightloss drug
Zepbound recently joined the list of obesity-fighting drugs administered as injections that has been approved by the FDA.
Three ways your environment affects your intelligence
These examples underscore the importance of environmental regulation and policies; otherwise, we might just be throwing away our intelligence.
The most damaging exercise myth
It’s a common belief that it’s normal for adults to be less physically active as they age. This might be the most pernicious exercise myth.
Red meat causes heart disease. Except when it doesn’t?
The problem is not scientific consensus on red meat, but how specialists analyze risk when proffering public guidelines.
Up Next
a Novo Nordisk office
Subscribe to Freethink for more great stories