Overview
Alcohol use disorder is responsible for a large worldwide burden of morbidity, premature mortality, and economic consequences resulting from accidents, violence, incarceration, decreased productivity, and increased healthcare spending. Acamprosate, also known by the brand name Campral, is a drug used for the maintenance of alcohol abstinence. It is a structural analogue of the neurotransmitter γ-aminobutyric acid (GABA). Acamprosate is the first medication specifically formulated for the maintenance of alcohol abstinence in ethanol-dependent patients after alcohol detoxification, unlike naltrexone and disulfiram. It was first approved by the FDA in 2004 and initially marketed by Forest Laboratories.
Background
Alcohol use disorder is responsible for a large worldwide burden of morbidity, premature mortality, and economic consequences resulting from accidents, violence, incarceration, decreased productivity, and increased healthcare spending. Acamprosate, also known by the brand name Campral, is a drug used for the maintenance of alcohol abstinence. It is a structural analogue of the neurotransmitter γ-aminobutyric acid (GABA). Acamprosate is the first medication specifically formulated for the maintenance of alcohol abstinence in ethanol-dependent patients after alcohol detoxification, unlike naltrexone and disulfiram. It was first approved by the FDA in 2004 and initially marketed by Forest Laboratories.
Indication
Acamprosate is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. It is also indicated for the maintenance of alcohol abstinence in patients who have undergone alcohol detoxification. This drug should be used with a psychosocial support program providing adequate support.
Associated Conditions
- Alcohol Abstinence
- Alcohol Dependency
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/06/24 | Phase 2 | Completed | |||
2024/03/15 | Phase 2 | Withdrawn | |||
2024/02/21 | Phase 4 | Recruiting | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | ||
2020/08/05 | Phase 2 | UNKNOWN | Hanyang University Seoul Hospital | ||
2019/01/28 | Phase 4 | Completed | |||
2018/08/17 | Phase 3 | Completed | |||
2016/12/20 | Early Phase 1 | Completed | |||
2015/03/10 | Phase 2 | Withdrawn | |||
2015/03/02 | Phase 3 | Terminated | |||
2014/08/15 | Phase 2 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Glenmark Pharmaceuticals Inc., USA | 68462-435 | ORAL | 333 mg in 1 1 | 4/30/2020 | |
| Major Pharmaceuticals | 0904-7213 | ORAL | 333 mg in 1 1 | 1/31/2022 | |
| Zydus Lifesciences Limited | 70771-1057 | ORAL | 333 mg in 1 1 | 11/6/2023 | |
| Marlex Pharmaceuticals Inc | 10135-636 | ORAL | 333 mg in 1 1 | 10/25/2019 | |
| Carilion Materials Management | 68151-4760 | ORAL | 333 mg in 1 1 | 1/31/2012 | |
| Mylan Pharmaceuticals Inc. | 0378-6333 | ORAL | 333 mg in 1 1 | 11/19/2014 | |
| Zydus Pharmaceuticals (USA) Inc. | 68382-569 | ORAL | 333 mg in 1 1 | 11/6/2023 | |
| American Health Packaging | 60687-121 | ORAL | 333 mg in 1 1 | 9/28/2023 |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| CAMPRAL acamprosate calcium 333 mg enteric coated tablet blister pack | 68410 | Medicine | A | 8/6/1999 | |
| ACAMPROSATE VIATRIS acamprosate calcium 333 mg enteric coated tablet blister pack | 298641 | Medicine | A | 3/6/2018 | |
| APO-ACAMPROSATE acamprosate calcium 333 mg enteric coated tablets blister | 286652 | Medicine | A | 12/21/2017 | |
| ACAMPROSATE-WGR acamprosate calcium 333 mg enteric coated tablets blister | 286653 | Medicine | A | 12/21/2017 | |
| CEMPRATE acamprosate calcium 333 mg enteric-coated tablet blister pack | 186209 | Medicine | A | 2/27/2018 |