NALMEFENE HYDROCHLORIDE
Nalmefene Hydrochloride Injection is indicated for the complete or partial reversal of effects induced by natural or synthetic opioid drugs. It is primarily used in the clinical management of patients with known or suspected opioid overdose. The drug specifically addresses life-threatening symptoms such as respiratory depression.
How NALMEFENE HYDROCHLORIDE Works
Nalmefene hydrochloride is a competitive opioid antagonist. It works by binding to opioid receptors in the central nervous system—specifically acting as an antagonist at the mu ($\mu$) and delta ($\delta$) receptors and as a partial agonist at the kappa ($\kappa$) receptor—thereby displacing opioid agonists and blocking their pharmacological effects.
Details
- Status
- Prescription
- First Approved
- 2022-02-08
- Routes
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Dosage Forms
- SOLUTION
NALMEFENE HYDROCHLORIDE Approval History
What NALMEFENE HYDROCHLORIDE Treats
2 indicationsNALMEFENE HYDROCHLORIDE is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Opioid Overdose
- Respiratory Depression
NALMEFENE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to NALMEFENE HYDROCHLORIDE
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04828005 results posted | OPNT003-PD-001 | Ph 1 | completed | Pharmacodynamic Evaluation of Intranasal Nalmefene |
| NCT04759768 results posted | OPNT003-PK-001 | Ph 1 | completed | Pharmacokinetic Evaluation of Intranasal Nalmefene |
| NCT05219669 results posted | OPNT003-PK-002 | Ph 1 | completed | Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens |
| NCT02382276 results posted | 339-14-002 JapicCTI-152806 | Ph 3 | completed | A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence |
| NCT02364947 results posted | 339-14-001 JapicCTI-152804 | Ph 3 | completed | A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-parallel-group Comparison Trial to Investigate the Effect of Nalmefene on Alcohol Consumption Reduction in Patients With Alcohol Dependence (Phase 3 Trial) |
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.
NALMEFENE HYDROCHLORIDE FDA Label Details
Indications & Usage
NALMEFENE HYDROCHLORIDE is indicated for the treatment of Opioid Overdose; Respiratory Depression.
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ZURNAI (AUTOINJECTOR)
Full clinical data, patents, trials, and competitive landscape for nalmefene hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.