Overview
Nalmefene, a 6-methylene analogue of naltrexone, is an opioid receptor antagonist. It acts as an antagonist at the mu (μ)-opioid and delta (δ)-opioid receptors and a partial agonist at the kappa (κ)-opioid receptor. In Europe, nalmefene oral tablets are used to reduce alcohol consumption in adults with alcohol dependence. Nalmefene was approved in the United States in 1995 as an antidote for opioid overdose. Nalmefene injection is used to manage known or suspected opioid overdose. It is used for complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. The nasal spray formulation of nalmefene was approved by the FDA in May 2023.
Indication
Nalmefene oral tablet is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms and who do not require immediate detoxification. Nalmefene should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption. Nalmefene should be initiated only in patients who continue to have a high DRL two weeks after the initial assessment. Nalmefene injection and nasal spray are indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. They are also indicated in the management of known or suspected opioid overdose. Nalmefene injection can be used for postoperative opioid overdose reversal.
Associated Conditions
- Alcohol Dependency
- Opioid Overdose
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/13 | Phase 2 | Not yet recruiting | |||
2024/12/06 | Phase 1 | Completed | |||
2024/05/10 | Phase 3 | Withdrawn | |||
2024/01/10 | Phase 1 | Completed | |||
2023/04/12 | Phase 4 | Withdrawn | |||
2022/09/14 | Phase 3 | Recruiting | |||
2022/04/21 | Phase 1 | Recruiting | Leiden University Medical Center | ||
2022/02/02 | Phase 1 | Completed | Opiant Pharmaceuticals Inc | ||
2021/04/01 | Phase 1 | Completed | Opiant Pharmaceuticals Inc | ||
2021/02/18 | Phase 1 | Completed | Opiant Pharmaceuticals Inc |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Chengdu Shuode Pharmaceutical Co., Ltd | 82432-101 | INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS | 0.1 mg in 1 mL | 12/8/2023 | |
| Indivior Inc. | 12496-0003 | NASAL | 2.7 mg in 100 uL | 11/20/2023 | |
| Purdue Pharma L.P. | 59011-960 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 1 mg in 1 mL | 12/1/2023 | |
| Chengdu Shuode Pharmaceutical Co., Ltd | 82432-102 | INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS | 2 mg in 2 mL | 12/8/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Nalmefene Hydrochloride Injection | 国药准字H20080805 | 化学药品 | 注射剂 | 7/3/2023 | |
| Nalmefene Hydrochloride Injection | 国药准字H20120020 | 化学药品 | 注射剂 | 4/29/2022 | |
| Nalmefene Hydrochloride Injection | 国药准字H20183012 | 化学药品 | 注射剂 | 11/21/2022 | |
| Nalmefene Hydrochloride Injection | 国药准字H20184018 | 化学药品 | 注射剂 | 3/22/2023 | |
| Nalmefene Hydrochloride Injection | 国药准字H20213788 | 化学药品 | 注射剂 | 10/19/2021 | |
| Nalmefene Hydrochloride Injection | 国药准字H20080645 | 化学药品 | 注射剂 | 3/22/2023 | |
| Nalmefene Hydrochloride Injection | 国药准字H20184007 | 化学药品 | 注射剂 | 3/22/2023 | |
| Nalmefene Hydrochloride Injection | 国药准字H20080652 | 化学药品 | 注射剂 | 7/4/2023 | |
| Nalmefene Hydrochloride Injection | 国药准字H20120123 | 化学药品 | 注射剂（小容量注射剂） | 8/23/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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