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.
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
Research Report
A Comprehensive Monograph on Acamprosate (DB00659)
Section 1: Executive Summary & Introduction
Acamprosate, chemically known as calcium acetylhomotaurinate, is a centrally acting small molecule drug established as a cornerstone in the pharmacotherapeutic management of Alcohol Use Disorder (AUD).[1] It is one of only three medications approved by the U.S. Food and Drug Administration (FDA) for this indication, alongside disulfiram and naltrexone, and was the first agent specifically formulated for the maintenance of alcohol abstinence in patients following detoxification.[1] The core therapeutic principle of acamprosate is to support sustained sobriety by reducing alcohol cravings and mitigating the protracted withdrawal symptoms that often lead to relapse.[4] It achieves this not by inducing an aversive reaction to alcohol, as seen with disulfiram, but by targeting the underlying neurobiological dysregulation caused by chronic alcohol consumption.[5] Specifically, acamprosate is hypothesized to restore the homeostatic balance between the brain's primary excitatory (glutamate) and inhibitory (gamma-aminobutyric acid, or GABA) neurotransmitter systems, which is profoundly disrupted by long-term alcohol exposure.[4]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/11 | Not Applicable | Not yet recruiting | Samer Gawrieh | ||
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 |
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 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
CAMPRAL | Mylan Pharmaceuticals ULC | 02293269 | Tablet (Delayed-Release) - Oral | 333 MG | 7/30/2007 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
CAMPRAL 333 mg COMPRIMIDOS RECUBIERTOS | 61201 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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