Overview
Baclofen is a gamma-aminobutyric acid (GABA) agonist used as a skeletal muscle relaxant. Although originally designed in 1962 to treat epilepsy, baclofen was not effective in treating this condition but instead was shown to reduce spasticity in selected patients. Baclofen was reintroduced in 1971 as a treatment for spasticity and was later approved by the FDA in 1977. Baclofen is used to manage severe muscle spasms of cerebral or spinal cord origins, including multiple sclerosis and traumatic brain injury. Baclofen was investigated for use in alcohol dependence and withdrawal; however, evidence is limited and there is inconsistent evidence to suggest its clinical efficacy in managing alcohol dependence or withdrawal symptoms.
Indication
Oral baclofen is indicated for the treatment of spasticity resulting from multiple sclerosis and is particularly useful for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. It may also be used to treat patients with spinal cord injuries and other spinal cord diseases. Baclofen should not be used to treat skeletal muscle spasms resulting from rheumatic disorders. Intrathecal baclofen is also indicated for the management of severe spasticity of the cerebral or spinal original in patients 4 years of age and older. It is reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable central nervous system side effects at effective doses. For use in spasticity due to traumatic brain injury, baclofen should be considered after at least one year of injury.
Associated Conditions
- Alcohol Dependency
- Severe Spasticity
- Spasticity
- Flexor spasm
- Severe cerebral origin Spasticity
- Severe spinal cord origin Spasticity
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/14 | Not Applicable | Recruiting | Adnan Imtiaj Rahul | ||
2025/02/21 | N/A | ENROLLING_BY_INVITATION | Corporacion Parc Tauli | ||
2024/08/21 | Phase 4 | Not yet recruiting | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal | ||
2023/12/19 | Not Applicable | Not yet recruiting | |||
2023/08/04 | Phase 3 | Recruiting | |||
2023/07/07 | Phase 2 | Not yet recruiting | |||
2023/06/27 | Phase 3 | Active, not recruiting | |||
2023/05/26 | N/A | Completed | |||
2023/04/18 | N/A | Not yet recruiting | Amsterdam UMC, location VUmc | ||
2022/11/15 | N/A | Recruiting | Saint Petersburg State University, Russia |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Advagen Pharma Limited | 72888-146 | INTRATHECAL | 1000 ug in 1 mL | 3/6/2023 | |
| Northwind Pharmaceuticals, LLC | 82868-013 | ORAL | 10 mg in 1 1 | 1/1/2024 | |
| Amneal Pharmaceuticals of New York LLC | 0115-1011 | ORAL | 5 mg in 1 1 | 12/30/2023 | |
| Aurobindo Pharma Limited | 59651-395 | ORAL | 20 mg in 1 1 | 11/17/2021 | |
| DIRECT RX | 61919-093 | ORAL | 10 mg in 1 1 | 9/27/2022 | |
| Advanced Rx Pharmacy of Tennessee, LLC | 80425-0157 | ORAL | 20 mg in 1 1 | 12/27/2022 | |
| Medsource Pharmaceuticals | 45865-275 | ORAL | 20 mg in 1 1 | 3/1/2024 | |
| A-S Medication Solutions | 50090-5838 | ORAL | 20 mg in 1 1 | 10/5/2021 | |
| Asclemed USA, Inc. | 76420-357 | ORAL | 10 mg in 1 1 | 8/13/2025 | |
| TruPharma LLC | 52817-321 | ORAL | 20 mg in 1 1 | 1/14/2021 |
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 |
|---|---|---|---|---|---|
| LIORESAL 10 TABLET 10 mg | SIN05330P | TABLET | 10 mg | 1/7/1991 | |
| COLMIFEN 10 TABLET 10 mg | SIN06831P | TABLET | 10 mg | 2/15/1992 | |
| APO-BACLOFEN TABLET 10 mg | SIN09087P | TABLET | 10 mg | 12/20/1996 | |
| PMS-BACLOFEN TABLET 10 mg | SIN10026P | TABLET | 10 mg | 9/22/1998 |
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 |
|---|---|---|---|---|---|
| BACLOFEN-RJIC baclofen 10mg tablet bottle | 421833 | Medicine | A | 1/3/2024 | |
| APO-BACLOFEN baclofen 25mg tablets bottle | 77576 | Medicine | A | 3/1/2001 | |
| LIORESAL intrathecal baclofen 10mg/5mL injection ampoule | 53836 | Medicine | A | 3/19/1996 | |
| LIORESAL intrathecal baclofen 10mg/20mL injection ampoule | 53835 | Medicine | A | 3/19/1996 | |
| BACLOFEN-DWRN baclofen 10mg tablet bottle | 421831 | Medicine | A | 1/3/2024 | |
| BACTHECAL baclofen 0.05 mg/1 mL intrathecal solution for injection ampoule | 227896 | Medicine | A | 8/7/2015 | |
| LIORESAL 25 baclofen 25 mg tablet bottle | 11039 | Medicine | A | 8/2/1991 | |
| APO-BACLOFEN baclofen 10mg tablet bottle | 77577 | Medicine | A | 3/1/2001 | |
| BACLOFEN-DWRN baclofen 25mg tablets bottle | 421832 | Medicine | A | 1/3/2024 | |
| LIORESAL intrathecal baclofen 50 microgram/1 mL injection | 53837 | Medicine | A | 3/19/1996 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| BACLOFEN TABLETS - 20MG | bdh inc. | 02147564 | Tablet - Oral | 20 MG / TAB | 12/31/1995 |
| MYLAN-BACLOFEN | Mylan Pharmaceuticals ULC | 02088398 | Tablet - Oral | 10 MG | 12/31/1994 |
| NOVO-BACLOFEN | novopharm limited | 02229937 | Tablet - Oral | 20 MG | 1/31/1997 |
| LIORESAL INTRATHECAL 0.05MG/ML | novartis pharmaceuticals canada inc | 02131048 | Solution - Intrathecal | 0.05 MG / ML | 12/31/1994 |
| LIORESAL INTRATHECAL 2MG/ML | novartis pharmaceuticals canada inc | 02131064 | Solution - Intrathecal | 2 MG / ML | 12/31/1994 |
| BACLOFEN INJECTION | Sterimax Inc | 02413647 | Solution - Intrathecal | 10 MG / 5 ML | 6/6/2014 |
| BACLOFEN | 02136104 | Tablet - Oral | 20 MG | 12/31/1994 | |
| BACLOFEN | sivem pharmaceuticals ulc | 02544679 | Tablet - Oral | 20 MG | 5/31/2024 |
| PRO-BACLOFEN | PRO DOC LIMITEE | 02152592 | Tablet - Oral | 20 MG | 12/31/1996 |
| RATIO-BACLOFEN | teva canada limited | 02236508 | Tablet - Oral | 20 MG | 12/16/1997 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| LIORESAL 0,05 MG/ML SOLUCIÓN INYECTABLE | Novartis Farmaceutica S.A. | 62346 | SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized |
| SPACYR 1 MG/ML SOLUCION INYECTABLE Y PARA PERFUSION | 80233 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized | |
| SPACYR 1 MG/ML SOLUCION INYECTABLE Y PARA PERFUSION EN JERINGA PRECARGADA | 80231 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EN JERINGA PRECARGADA | Uso Hospitalario | Not Commercialized | |
| LIORESAL 10 MG COMPRIMIDOS | Novartis Farmaceutica S.A. | 52180 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LIORESAL 2 MG/ML SOLUCIÓN PARA PERFUSIÓN | Novartis Farmaceutica S.A. | 62348 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| SPACYR 0,5 MG/ML SOLUCION INYECTABLE Y PARA PERFUSION EFG | 80235 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized | |
| SPACYR 0,5 MG/ML SOLUCION INYECTABLE Y PARA PERFUSION EN JERINGA PRECARGADA | 80230 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EN JERINGA PRECARGADA | Uso Hospitalario | Not Commercialized | |
| SPACYR 0,05 MG/ML SOLUCION INYECTABLE Y PARA PERFUSION EN JERINGA PRECARGADA | 80229 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EN JERINGA PRECARGADA | Uso Hospitalario | Not Commercialized | |
| SPACYR 2 MG/ML SOLUCION INYECTABLE Y PARA PERFUSION EN JERINGA PRECARGADA | 80232 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EN JERINGA PRECARGADA | Uso Hospitalario | Not Commercialized | |
| LIORESAL 0,5 MG/ML SOLUCIÓN PARA PERFUSIÓN | Novartis Farmaceutica S.A. | 62347 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | 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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