MedPath

Baclofen

Generic Name
Baclofen
Brand Names
Fleqsuvy, Gablofen, Kemstro, Lioresal, Lyvispah, Ozobax
Drug Type
Small Molecule
Chemical Formula
C10H12ClNO2
CAS Number
1134-47-0
Unique Ingredient Identifier
H789N3FKE8

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.
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