Wednesday, July 17, 2024

FDA approves new nasal spray to reverse opioid overdose


WASHINGTON – US health regulators on Monday approved an easier-to-use version of a drug to reverse overdoses caused by fentanyl and other opioids that are driving the country’s drug crisis.

Opvee is similar to naloxone, the life-saving drug that has been used for decades to combat 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 approved OPV, a nasal spray update of the drug nalmefene, which was first approved as an injectable in the mid-1990s but was later pulled 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 downsides to its longer-lasting effects. The drug will be available via prescription and is approved for patients 12 years of age and older.

In studies funded by the federal government, OPV 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 is expected to launch the Opvee in October at the earliest.

As the opioid epidemic shifted to fentanyl and other synthetic opioids, drug industry researchers 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 the overdose.

Read more, Inside the Emerging Xylazine Addiction Crisis in America

Scientists at the National Institutes of Health worked with pharmaceutical researchers on a nasal spray version of nalmefene that would revive users more quickly, as well as protect them from relapse. The trial and development were 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 purpose of this was to have a drug that would last longer but also get to the brain faster,” 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 cause acute withdrawal symptoms, including nausea, diarrhea, muscle cramps, and anxiety. With naloxone, those symptoms can last for 30 to 40 minutes.

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

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

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

“We are not suffering from a shortage of naloxone where we need to use a substitute,” he said. “We have a lot and it works out perfectly well.”

The FDA approval comes after two big jumps in drug overdose deaths last year during the pandemic. According to the latest data from the Centers for Disease Control and Prevention, there will be more than 109,000 fatal overdoses recorded in 2022.

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 fight 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 not to sell or dispense the drug to anyone without a prescription.

In the latest federal push, the FDA recently approved Narcan to be sold over the counter. The change will allow the new version of the drug to be stocked in grocery stores, vending machines and other retail locations. 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.

Indiewire 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 that distribute to first responders and those at risk of overdose. Indivior has told investors that Opvee could eventually generate annual sales of between $150 million and $250 million.

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