FDA approves new nasal spray ‘Opvee’ to treat opioid overdose NPR

This photo provided by Indivior in May 2023 shows the company’s drug Opvee. US health regulators have approved the drug for reversing fentanyl and other potent opioid overdoses.

Split via AP

.

.

Split via AP

This photo provided by Indivior in May 2023 shows the company’s drug Opvee. US health regulators have approved the drug for reversing fentanyl and other potent opioid overdoses.

Split via AP

WASHINGTON — U.S. health regulators on Monday approved a new, easy-to-use version of the drug for reversing fentanyl and other opioid overdoses. sparking a domestic drug crisis.

Opvee is similar to naloxone, a life-saving drug that has been used for decades to quickly combat heroin, fentanyl and prescription painkiller overdoses. Both work by blocking the effects of opioids in the brain, allowing breathing and blood pressure to return to normal in people who have recently overdosed.

The Food and Drug Administration backed Opvee, a modified nasal spray for the drug nalmefene, which was first approved as an injection in the mid-1990s but later pulled from the market due to poor sales. Naloxone comes both as a nasal spray and as an injection.

It is not immediately clear how the new drug will be used differently compared to naloxone, with some experts seeing a potential downside in its longer duration of effect. . This drug is available by prescription and is approved for patients over the age of 12.

In a federally funded study, Opvee achieved recovery results similar to Narcan, the leading brand of naloxone nasal spray.

Opvee was developed by Opiant Pharmaceuticals. Opianto Pharmaceuticals was recently acquired by rival Indiviol, which makes several drugs for opioid addiction. Indivior plans to launch his Opvee as early as October.

As the opioid epidemic shifted to fentanyl and other synthetic opioids, researchers in the pharmaceutical industry and the U.S. government turned to new roles for the drug.

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

Scientists at the National Institutes of Health worked with pharmaceutical researchers to develop a nasal spray version of nalmefene that rapidly resuscitates users while preventing relapses. The testing and development was funded by his more than $18 million grant from the US government’s Office of Biomedical Advanced Research and Development and his NIH, which also helped design the study.

“The aim was to develop a drug that not only lasts longer, but reaches the brain very quickly,” said Dr. Nora Bolkow, director of the National Institute on Drug Abuse.

Still, some experts point to potential downsides.

A side effect of all opioid antagonists is to cause severe withdrawal symptoms such as nausea, diarrhea, muscle cramps, and anxiety. With naloxone, these symptoms can last 30-40 minutes.

Rutgers University’s Dr. Luis Nelson said that with nalmefene, these problems can last for more than six hours and require additional treatment and management by a medical professional.

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

Nelson said it’s easy to give a second and third dose once the naloxone effect wears off.

“We are not suffering from a shortage of naloxone that requires us to use alternatives,” he said. “We have a lot of it, and it works perfectly fine.”

The FDA approval comes amid a slight increase in drug overdose deaths last year after two major spikes in drug overdose deaths during the pandemic. More than 109,000 fatal overdoses were recorded in 2022, according to the latest statistics from the Centers for Disease Control and Prevention.

More than two-thirds of those deaths are associated with fentanyl and other synthetic opioids, which have largely been replaced by heroin and prescription opioids.

Naloxone has long been at the center of government efforts to combat the overdose crisis at the federal and local levels. Police, firefighters, and other first responders routinely carry this drug. And authorities 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 initiative, the FDA recently approved Narcan for over-the-counter sales. This change will allow the new version of the drug to be stocked in grocery stores, vending machines and other retail outlets. The nasal spray includes updated instructions for general users and will be available this summer. Emergent Biosolutions has yet to announce pricing for the over-the-counter version.

Indiviol said it is still working out how to charge for its drug. It will compete in the same market as naloxone, with most buyers being local governments and community groups that distribute it to first responders and people at risk of overdoses. Indivior told investors that Opvee could eventually make $150 million to $250 million in annual revenue.