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.
Background
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 |
---|---|---|---|---|---|
2025/02/21 | 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 | ||
2022/08/26 | Phase 2 | Completed |
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 | 5/22/2025 | |
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 |
---|---|---|---|---|---|
Baclofen Tablets | 国药准字H20249233 | 化学药品 | 片剂 | 10/29/2024 | |
Baclofen Tablets | 国药准字HC20171015 | 化学药品 | 片剂 | 3/19/2025 | |
Baclofen Tablets | 国药准字H19980103 | 化学药品 | 片剂 | 7/16/2024 | |
Baclofen Tablets | HC20171015 | 化学药品 | 片剂 | 6/19/2020 | |
Baclofen Tablets | 国药准字H20010423 | 化学药品 | 片剂 | 8/24/2020 | |
Baclofen Tablets | 国药准字HJ20140326 | 化学药品 | 片剂 | 2/23/2024 | |
Baclofen Oral Solution | 国药准字H20253329 | 化学药品 | 口服溶液剂 | 1/24/2025 | |
Baclofen Oral Solution | 国药准字H20249626 | 化学药品 | 口服溶液剂 | 12/1/2024 |
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 |