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Baclofen ER
Baclofen ER is a GABA-B receptor agonist that reduces neuronal excitability and muscle tone by enhancing inhibitory neurotransmission in the central nervous system.
Baclofen ER is a GABA-B receptor agonist that reduces neuronal excitability and muscle tone by enhancing inhibitory neurotransmission in the central nervous system. Used for Spasticity associated with multiple sclerosis, Spasticity resulting from spinal cord injury or disease, Muscle spasticity of other origins.
At a glance
| Generic name | Baclofen ER |
|---|---|
| Also known as | placebo drug |
| Sponsor | Alkermes, Inc. |
| Drug class | GABA-B receptor agonist |
| Target | GABA-B receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | FDA-approved |
Mechanism of action
Baclofen acts as a selective agonist at GABA-B receptors, which are inhibitory G-protein coupled receptors found throughout the central nervous system. By activating these receptors, it increases chloride channel conductance and hyperpolarizes neurons, leading to decreased excitatory neurotransmitter release and reduced muscle spasticity. The extended-release formulation provides sustained therapeutic levels with less frequent dosing compared to immediate-release formulations.
Approved indications
- Spasticity associated with multiple sclerosis
- Spasticity resulting from spinal cord injury or disease
- Muscle spasticity of other origins
Common side effects
- Drowsiness/sedation
- Dizziness
- Weakness/fatigue
- Headache
- Nausea
- Confusion
- Insomnia
Key clinical trials
- Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis (PHASE3)
- A Study With IPX056 in Subjects With Spasticity Associated With Multiple Sclerosis (PHASE2)
- IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis (PHASE3)
- A Study of Baclofen ER (PHASE2)
- ALK29-002: A Study of Baclofen Formulations in Healthy Adults (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Baclofen ER CI brief — competitive landscape report
- Baclofen ER updates RSS · CI watch RSS
- Alkermes, Inc. portfolio CI