Neurobehavioral Disorders

FDA Approves Zurnai for Emergency Treatment of Opioid Overdose

Diana Ernst, RPh
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Publish Date
Each single-dose Zurnai autoinjector delivers a dose of 1.5mg nalmefene (base) in 0.5mL.

The Food and Drug Administration (FDA) has approved Zurnai™, the first nalmefene HCl autoinjector for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients aged 12 years and older.

Nalmefene is an opioid antagonist that reverses the effects of natural and synthetic opioids, including respiratory depression, sedation, and hypotension. The approval was supported by safety and pharmacokinetic studies as well as data from an experimental clinical opioid-induced respiratory depression model in 24 opioid-experienced, non-opioid dependent individuals. 

Following administration of Zurnai, the time to onset of reversal of respiratory depression was found to be between 2.5 to 5 minutes. Full recovery of respiratory drive was observed between 5 and 15 minutes after administration.

The most common adverse reactions reported were feeling hot, nausea, headache, dizziness, chills, vomiting, allodynia, palpitations, tinnitus, ear discomfort, feeling abnormal, burning sensation, hot flush, and irritability.

The ready-to-use autoinjector device can be administered via intramuscular or subcutaneous injection. Each single-dose Zurnai autoinjector delivers a dose of 1.5mg nalmefene (base) in 0.5mL.

This article originally appeared on MPR

References:
  1. US Food and Drug Administration. FDA approves first nalmefene hydrochloride auto-injector to reverse opioid overdose. August 7, 2024. https://www.prnewswire.com/news-releases/fda-approves-first-nalmefene-hydrochloride-auto-injector-to-reverse-opioid-overdose-302217282.html.
  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. News release. Purdue Pharma. August 7, 2024. https://www.businesswire.com/news/home/20240807347421/en/FDA-Approves-Zurnai%E2%84%A2-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.
  3. Zurnai. Package insert. Purdue Pharma; 2024. Accessed August 8, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218590s000lbl.pdf.