OPVEE (nalmefene hydrochloride)
OPVEE is an opioid antagonist indicated for the emergency treatment of known or suspected overdose induced by natural or synthetic opioids. It is approved for use in adults and pediatric patients aged 12 years and older who exhibit respiratory or central nervous system depression. The nasal spray is intended for immediate administration in settings where opioids may be present, though it is not a substitute for professional emergency medical care.
How OPVEE Works
OPVEE functions as an antagonist at opioid receptors. By binding to these receptors, the drug works to reverse the effects of natural or synthetic opioids. This action addresses life-threatening symptoms such as respiratory and central nervous system depression during an overdose.
Details
- Status
- Prescription
- First Approved
- 2023-05-22
- Patent Cliff
- 2042
- Routes
- NASAL
- Dosage Forms
- SPRAY
OPVEE Approval History
What OPVEE Treats
3 indicationsOPVEE is approved for 3 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Opioid Overdose
- Respiratory Depression
- Central Nervous System Depression
OPVEE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 OPVEE
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.
OPVEE FDA Label Details
Indications & Usage
FDA Label (PDF)OPVEE is indicated for the treatment of Opioid Overdose; Respiratory Depression; Central Nervous System Depression.
OPVEE Patents & Exclusivity
Patents (2 active)
Exclusivity
Pro Intelligence Preview
Deep insights for OPVEE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2042
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 7 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.