Treats known or suspected overdose induced by natural or synthetic opioids. Sold as Revex, Opvee, Zurnai. Every FDA application for this active ingredient: 3 branded and 2 generic.
As of Nov 15, 2026, FDA lists 5 applications for Nalmefene Hydrochloride (sold as Revex, Opvee, Zurnai), first approved Apr 17, 1995, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Opvee | Part D | $79K | +1109% | 712 |
| Nalmefene Implant in Healthy SubjectsOpioid Abuse and Addiction · ReacX Pharmaceuticals, Inc. | Phase 1 | Recruiting | Jan 8, 2026 |
| TH104 for the Treatment of Pruritus in Primary Biliary CholangitisPruritus, Primary Biliary Cholangitis · Tharimmune Inc | Phase 2 | Not yet recruiting | Dec 13, 2024 |
| NAlmefene Versus Placebo in Addition to Treatment as Usual on Craving in Behavioural AddictionsBehavioural Addiction · Nantes University Hospital | Phase 3 | Recruiting | Sep 14, 2022 |
| Apr 17, 1995 | RevexNDA 20459 · New molecular entity | Hikma | 3 | Discontinued |
| Feb 8, 2022 | Nalmefene HydrochlorideANDA 212955 | Knoa Pharma | 0 | Marketed |
| May 22, 2023 | OpveeNDA 217470 · New dosage form | Indivior | 0 | Marketed |
| Nov 15, 2023 | Nalmefene HydrochlorideANDA 216007 | Chengdu Shuode | 0 | Marketed |
| Aug 7, 2024 | ZurnaiNDA 218590 · New dosage form | Knoa Pharma | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Hikma