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

US health regulators in WASHINGTON on Monday approved a new, easy-to-use version of a drug to reverse overdoses caused by fentanyl and other opioids driving 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 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, a nasal spray update of the drug nalmefene, first approved as an injection in the mid-1990s but later removed from the market due to low sales. Naloxone comes as both a nasal spray and an injection.

It’s not immediately clear how the new drug will be used differently than naloxone, and some experts see potential drawbacks in its long-acting effect. The drug will be available by prescription and is approved for patients 12 years of age 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 opioid addiction drugs. Indivior plans to launch Opvee no earlier than October.

As the opioid epidemic has shifted towards fentanyl and other synthetic opioids, researchers in the pharmaceutical industry and the US government have seen a new role for the drug.

Because fentanyl stays in the body longer than heroin and other opioids, some people may require multiple doses of naloxone over several hours to fully reverse an overdose.

Scientists at the National Institutes of Health worked with pharmaceutical researchers on a nasal spray version of nalmefene that would quickly resurrect users, while also protecting them from relapses. Testing and development was funded with more than $18 million in grants from the US government’s Biomedical Advanced Research and Development Authority and the NIH, which also assisted in study design.

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

However, 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 could last 30 to 40 minutes.

Dr. Lewis Nelson of Rutgers University says these problems can last for six hours or more on nalmefene, requiring extra treatment and management from healthcare professionals.

“The risk of long-lasting withdrawal is very real, and we try to avoid it,” said Nelson, an emergency medicine physician and former FDA opioid adviser.

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

“We are not suffering from a naloxone shortage where we need to use an alternative,” he said. “We have plenty of it and it works perfectly.”

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 latest data from the Centers for Disease Control and Prevention.

More than two-thirds of these deaths have been linked to fentanyl and other synthetic opioids, which have largely replaced heroin and prescription opioids.

Naloxone has long been the focus of government efforts to combat the overdose crisis at the federal and local levels. Police, firefighters, and other first responders routinely carry the drug. 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 outlets. The nasal spray that 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 the majority of buyers are local governments and community groups who distribute to first responders and those at risk of overdoses. Indivior told investors that Opvee could eventually generate between $150 million and $250 million in annual sales.