Revex, Selincro(nalmefene)
Nalmefene, Opvee, Selincro, Zurnai (nalmefene) is a small molecule pharmaceutical. Nalmefene was first approved as Revex on 1995-04-17. It is used to treat drug overdose, opioid-related disorders, and respiration disorders in the USA. It has been approved in Europe to treat alcohol-related disorders. The pharmaceutical is active against mu-type opioid receptor and kappa-type opioid receptor. In addition, it is known to target delta-type opioid receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Nalmefene, Opvee, Zurnai (discontinued: Revex)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Nalmefene hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OPVEE | Indivior | N-217470 RX | 2023-05-22 | 1 products, RLD, RS |
| ZURNAI (AUTOINJECTOR) | Purdue Pharma | N-218590 RX | 2024-08-07 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nalmefene hydrochloride | ANDA | 2024-12-16 |
| opvee | New Drug Application | 2025-07-08 |
| zurnai | New Drug Application | 2025-06-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| opioid-related disorders | EFO_0005611 | D009293 | F11 |
| respiration disorders | — | D012120 | J00-J99 |
| drug overdose | — | D062787 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
NALMEFENE HYDROCHLORIDE, OPVEE, INDIVIOR | |||
| 2026-05-22 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Nalmefene Hydrochloride, Opvee, Indivior | |||
| 11458091 | 2038-07-10 | DP | U-3630 |
HCPCS
No data
Clinical
Clinical Trials
39 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 4 | 2 | 6 | 4 | 3 | 18 |
| Opiate overdose | D000083682 | — | — | 2 | — | 1 | 1 | — | 4 |
| Resuscitation | D012151 | — | — | — | — | — | 1 | — | 1 |
| Smoking | D012907 | EFO_0004318 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alcohol drinking | D000428 | EFO_0004329 | — | 1 | 2 | 1 | — | 1 | 4 |
| Respiratory insufficiency | D012131 | — | J96.9 | 1 | — | 1 | — | — | 2 |
| Depression | D003863 | — | F33.9 | 1 | — | 1 | — | — | 2 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | 1 | — | — | 1 |
| Fibrosis | D005355 | — | — | — | — | 1 | — | — | 1 |
| Gambling | D005715 | EFO_1001926 | F63.0 | — | 1 | 1 | — | — | 1 |
| Addictive behavior | D016739 | EFO_0004347 | — | — | — | 1 | — | — | 1 |
| Drug overdose | D062787 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | 1 | 1 | — | — | 1 | 2 |
| Pruritus | D011537 | — | L29 | — | 2 | — | — | — | 2 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 1 | — | — | — | 1 |
| Fatty liver | D005234 | EFO_0003934 | — | — | 1 | — | — | — | 1 |
| Smoking cessation | D016540 | EFO_0004319 | — | — | 1 | — | — | — | 1 |
| Impulsive behavior | D007175 | — | — | — | 1 | — | — | — | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 1 | — | — | — | 1 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 1 | — | — | — | 1 |
| Impulse control disruptive and conduct disorders | D007174 | — | F63.2 | — | 1 | — | — | — | 1 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 2 | — | — | — | — | 2 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anesthesia | D000758 | — | — | — | — | — | — | 1 | 1 |
| Hyperalgesia | D006930 | — | — | — | — | — | — | 1 | 1 |
| Borderline personality disorder | D001883 | — | F60.3 | — | — | — | — | 1 | 1 |
| Personality disorders | D010554 | — | F60.6 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Nalmefene |
| INN | nalmefene |
| Description | Nalmefene is a morphinane alkaloid. |
| Classification | Small molecule |
| Drug class | narcotic agonists/antagonists (normorphine type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C=C1CC[C@@]2(O)[C@H]3Cc4ccc(O)c5c4[C@@]2(CCN3CC2CC2)[C@H]1O5 |
Identifiers
| PDB | — |
| CAS-ID | 55096-26-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL982 |
| ChEBI ID | 7457 |
| PubChem CID | 5284594 |
| DrugBank | DB06230 |
| UNII ID | TOV02TDP9I (ChemIDplus, GSRS) |
Target
Agency Approved
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Safety
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281 adverse events reported
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