FDA approves nalmefene hydrochloride auto-injector for opioid overdose

Key takeaways:

• Nalmefene can reduce the effects of opioid overdoses, like low BP, when administered quickly.
• Zurnai was supported by safety and pharmacokinetic studies and is available by prescription only.

The FDA approved Zurnai, the first nalmefene hydrochloride auto-injector, for emergency treatment of opioid overdose in adults and youth aged 12 years and older.

Recent CDC data showed 81,083 overdose deaths involving opioids in United States in 2023, a decrease of over 3,000 deaths from 2022.

“The FDA remains focused on broadening access to opioid overdose reversal agents, including naloxone and nalmefene. Today’s approval adds a new nalmefene product and route of administration to support greater options for opioid overdose reversal,” Robert M. Califf, MD, FDA commissioner, said in a press release. “Since launching the FDA Overdose Prevention Framework in 2022, the agency continues to build upon efforts that address the overdose crisis currently impacting the nation.”

The FDA previously approved the first nasal spray form of nalmefene hydrochloride for opioid overdoses last year.

The single-dose Zurnai (Purdue Pharma, LLP) delivers 1.5 mg of nalmefene under the skin or into muscle, which can reduce opioid overdose effects like low BP, respiratory depression and sedation when administered quickly, the release noted.

Common adverse effects include chills, dizziness, nausea, headache, palpitations, feeling pain from actions that are not typically painful, ear discomfort, hot flush, burning sensation, feeling abnormal, vomiting and irritability.

The product’s approval was supported by safety and pharmacokinetic studies, in addition to a study in healthy individuals who use opioids recreationally, the FDA said.

The agency advised Zurnai is available by prescription only and the use of nalmefene hydrochloride in those with opioid dependency could lead to opioid withdrawal.

The approval comes as the U.S. Supreme Court ruled that the Sackler family could not be protected from future lawsuits for their role in the opioid epidemic and dismantled the Purdue Pharma bankruptcy settlement.

The Sackler family owned and operated Purdue Pharma, which manufactured OxyContin (oxycodone, Purdue Pharma, LLP) and misleadingly claimed it was a less addictive drug.

“Zurnai can be an important new tool to save lives in critical moments,” Purdue Pharma President and CEO Craig Landau, MD, said in a company-issued press release. “We are committed to delivering solutions to help address the opioid overdose crisis and are working to provide Zurnai at no profit to the company.”

References:

• FDA Approves first nalmefene hydrochloride auto-injector to reverse opioid overdose. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-nalmefene-hydrochloride-auto-injector-reverse-opioid-overdose. Published Aug. 7, 2024. Accessed Aug. 8, 2024.
• FDA approves Zurnai (nalmefene injection) auto-injector for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients 12 years and older. Available at: https://www.purduepharma.com/news/2024/08/07/fda-approves-zurnai-nalmefene-injection-auto-injector-for-the-emergency-treatment-of-known-or-suspected-opioid-overdose-induced-by-natural-or-synthetic-opioids-in-adults-and-pediatric-patie/. Published Aug. 7, 2024. Accessed Aug. 8, 2024.