FDA Approves New Fentanyl and Opioid Overdose Reversal Spray

Wim De Gent
By Wim De Gent
May 23, 2023US News
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FDA Approves New Fentanyl and Opioid Overdose Reversal Spray
The nasal-spray format and nalmefene-based opioid receptor antagonist OPVEE from Indivior is shown in May, 2023. (Indivior via AP)

The U.S. Food and Drug Administration (FDA) on Monday approved an updated version—in nasal spray format—of a medication that reverses overdoses caused by fentanyl and other opioids.

The new product, OPVEE, from Indivior PLC, is chemically similar to naloxone—the life-saving drug known for immediately reversing the effects of heroin, fentanyl, and prescription opioid overdoses when administered in time.

Both OPVEE and naloxone work in the same manner: as opioid receptor antagonists, they block the chemical effect of opioids in the brain, thus reversing their paralyzing effects on breathing and heart function.

OPVEE is a reformulation of the drug nalmefene, which was first approved as an injection in the mid-1990s but was later removed from the market due to low sales.

With the shift in recent decades from prescription drugs and plant-based drugs—such as heroin and cocaine—to much more potent synthetic opioids like fentanyl and its analogs, researchers in the pharmaceutical industry saw a new role for the drug.

Though highly efficient, naloxone only remains active for between 30 minutes and two hours, after which a user may relapse into overdose. This is especially the case with fentanyl, as it stays in the body much longer than heroin and other opioids.

New Approach

Pharmaceutical researchers teamed up with scientists at the National Institutes of Health (NIH) to make sure the new drug remains active for a much longer period than naloxone, while also quickly resuscitating users.

“OPVEE’s FDA approval represents a significant achievement in the development of new treatment options to address today’s era of opioid overdoses that are driven by powerful synthetic opioids, such as fentanyl,” said Indivior CEO Mark Crossley in a press release. “OPVEE is an emergency treatment for the fast reversal of respiratory depression triggered by natural or synthetic opioids, including fentanyl, and we are committed to making this novel rescue medication widely available to those who need it most to help save lives.”

“Despite our collective effort to stem opioid abuse in America, addiction can happen to anyone, and millions of people are at risk for not only opioid overdose, but also poisoning from illicit synthetic opioids such as fentanyl,” said Dr. Jerome Adams, the executive director of health equity initiatives at Purdue University. “With OPVEE, first responders will have a fast and long-acting rescue medication option to combat the current opioid epidemic and save lives.”

Testing and development was funded by more than $18 million in grants from the U.S. government’s Biomedical Advanced Research and Development Authority and the NIH, which also helped design the studies.

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

But there is a downside, too: all currently existing opioid reversal drugs cause, within minutes, intense withdrawal symptoms, including nausea, diarrhea, muscle cramps, and anxiety, as they forcefully neutralize the effect of the opioids.

With naloxone, those symptoms typically last for 30 to 40 minutes. With OPVEE, these effects can last six hours or more, requiring extra care and assistance from health professionals.

“The risk of long-lasting withdrawal is very real and we try to avoid it,” said Dr. Lewis Nelson of Rutgers University, an emergency medicine physician and former adviser to the FDA on opioids.

He added that it’s easy enough to give a second or third dose of naloxone when it wears off. “We’re not suffering from a naloxone shortage,” he said. “We have plenty of it and it works perfectly well.”

The FDA recently approved the over-the-counter sale of Narcan—a nasal spray version of naloxone made by Emergent BioSolutions. The approval allows it to be stocked in grocery stores, vending machines, and other retail locations. Narcan is expected to become available this summer.

OPVEE (nalmefene) will be available via prescription, and has been approved for patients aged 12 and older. It will be available in nasal spray format in October at the earliest, according to its manufacturer, Indivior.

The Associated Press contributed to this article.

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