New nasal spray to reverse fentanyl and other opioid overdoses gets FDA approval

US health regulators on Monday approved a new, easy-to-use version of a drug to reverse overdoses caused by fentanyl and other opioids driving the country’s drug crisis.

Opvee is similar to naloxone, the life-saving drug that’s been used for decades to quickly counteract heroin, fentanyl, and painkiller overdoses. 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, a nasal spray update of the drug nalmefene, which was first approved as an injection in the mid-1990s but was later removed from the market due to declining 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 long-acting effect. The drug will be available by prescription and is approved for patients 12 years of age and older.

In studies funded by the federal government, OpVie achieved similar healing results to Narcan, the leading brand of naloxone nasal spray.

Opvee was developed by Opiant Pharmaceuticals, which was recently acquired by Indivior, the maker of several medications for opioid addiction. Indivior expects to launch Opvee in October at the earliest.

As the opioid epidemic 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 completely reverse an overdose.

Scientists at the National Institutes of Health worked with pharmaceutical researchers on a nasal spray version of nalmefene that would quickly revive users, while also 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 National Institutes of Health, which also helped design the studies.

“The whole goal was to get a drug that lasts longer but also gets to the brain very quickly,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse.

Some experts still see potential downsides.

A side effect of all opioid reversing medications is that they create severe withdrawal symptoms including nausea, diarrhea, muscle cramps, and anxiety. With naloxone, these symptoms may last 30 to 40 minutes.

These problems can last six hours or more with nalmefene, says Dr. Lewis Nelson of Rutgers University, requiring additional treatment and management by health professionals.

“The risk of long-term withdrawal is very real and we try to avoid it,” said Nelson, an emergency physician and former FDA advisor on opioids.

It’s easy to give a second or third dose of naloxone if it wears off, Nelson said.

“We’re not in a naloxone shortage where we need to use an alternative,” he said. “We have a lot of it and it’s doing really well.”

The FDA approval comes as drug overdose deaths rose slightly last year after two big jumps during the pandemic. More than 109,000 fatal overdoses were recorded in 2022, according to the most recent figures from the Centers for Disease Control and Prevention.

More than two-thirds of these deaths were related 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 combat the overdose crisis at both the federal and local levels. Police, firefighters, and first responders routinely carry narcotics. Officials in all 50 states have ordered pharmacists to sell or dispense the drug without a prescription.

In its latest federal push, the FDA recently approved Narcan for sale without a prescription. The change would allow the new version of the drug to be stored in grocery stores, vending machines and other retail locations. The nasal spray—which includes updated instructions for regular users—is expected to be released this summer. Emergent Biosolutions has not yet announced the price of the over-the-counter version.

Endeavor said it was still studying what it would charge for its drug. It will compete in the same market as naloxone, with most buyers being from local governments and community groups that distribute to first responders and those at risk of overdose. Indivior told investors that Opvee could eventually generate annual sales of $150 million to $250 million.