ZURNAI (AUTOINJECTOR)
Zurnai (nalmefene hydrochloride) is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, manifested by respiratory and/or central nervous system depression. It is used for the complete or partial reversal of effects induced by natural or synthetic opioids in adult and pediatric patients.
How ZURNAI (AUTOINJECTOR) Works
Nalmefene hydrochloride functions as a long-acting opioid antagonist. It competitively binds to mu ($\mu$), kappa ($\kappa$), and delta ($\delta$) opioid receptors in the central nervous system, with the highest affinity for mu receptors. By displacing opioid agonists from these sites, it reverses their pharmacological effects, including respiratory depression, sedation, and hypotension. Unlike naloxone, nalmefene has a significantly longer half-life, providing a more prolonged duration of antagonism.
Details
- Status
- Prescription
- First Approved
- 2024-08-07
- Routes
- INTRAMUSCULAR, SUBCUTANEOUS
- Dosage Forms
- SOLUTION
ZURNAI (AUTOINJECTOR) Approval History
What ZURNAI (AUTOINJECTOR) Treats
2 indicationsZURNAI (AUTOINJECTOR) is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Opioid Overdose
- Respiratory Depression
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZURNAI (AUTOINJECTOR) FDA Label Details
ProIndications & Usage
FDA Label (PDF)Nalmefene Hydrochloride Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose.
ZURNAI (AUTOINJECTOR) Patents & Exclusivity
Patents (2 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.