FDA Approves Zurnai Auto-Injector for Opioid Overdose

BREAKING NEWS

The US Food and Drug Administration approved Zurnai for the emergency treatment of natural or synthetic opioid overdose in patients 12 years of age and older.¹

The single dose auto-injector of Zurnai delivers 1.5 mg of nalmefene hydrochloride per actuation. An opioid receptor agonist, nalmefene reverses the respiratory and central nervous system depression associated with opioid overdose if the drug is administered promptly. Although a nasal spray formulation of the drug was approved by the FDA in May 2023, Zurnai is the first nalmefene hydrochloride auto-injector approved for this indication. The drug had been granted Fast Track and Priority Approval by the FDA.¹

Zurnai can be administered subcutaneously or intramuscularly. It is available in single-dose, pre-filled auto-injectors, similar to those used for patients with severe allergies, to aid in quick administration, even on the community level, but it is available by prescription only. Patients who are opioid dependent may experience withdrawal symptoms following administration. Other reported adverse events included dizziness, nausea, headache, chills, vomiting, allodynia, palpitations, tinnitus, ear discomfort, feeling abnormal, burning sensation, hot flushes, and irritability.¹

"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 statement. "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."¹

“We are pleased to gain approval of Zurnai, the nalmefene auto-injector for use by healthcare providers or anyone in the community,” Craig Landau, MD, president and chief executive officer of Purdue, the makers of Zurnai, said to the press. “Zurnai can be an important new tool to save lives in critical moments. 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.”²

The opioid epidemic continues to plague the United States. According to the Centers for Disease Control, opioid overdose deaths have continued to rise since 1999, and the National Institute of Drug Abuse estimates there were more than 80,000 opioid overdose deaths in 2022.^3,4

Read more about the opioid epidemic via articles and clinical insights at psychiatrictimes.com. Explore more on issues in addiction in our 2024 Addiction Special Issue.

References

1. FDA Approves First Nalmefene Hydrochloride Auto-Injector to Reverse Opioid Overdose. PR Newswire. August 7, 2024.

2. 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. Purdue. August 7, 2024. Accessed August 7, 2024. 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/

3. CDC. Understanding the Opioid Overdose Epidemic. Accessed August 7, 2024. https://www.cdc.gov/overdose-prevention/about/understanding-the-opioid-overdose-epidemic.html

4. NIDA. Drug Overdose Rates. Accessed August 7, 2024. https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates