Baclofen
| Evidence Level: L4 | Predicted Indications: 2 |
Table of Contents
Baclofen: From Spasticity to Attention Deficit-Hyperactivity Disorder
One-Sentence Summary
Baclofen is a widely marketed oral GABA-B receptor agonist, generally used as a muscle relaxant for spasticity. The TxGNN model predicts it may be effective for attention deficit-hyperactivity disorder (ADHD), but so far the support is only 10 publications (reviews and rodent studies) and 0 clinical trials. The high model score is not backed by any ADHD-specific human evidence.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the provided data (baclofen is generally used for spasticity) |
| Predicted New Indication | Attention deficit-hyperactivity disorder |
| TxGNN Prediction Score | 99.32% |
| Evidence Level | L4 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the Evidence Pack. Based on general pharmacology, baclofen is a GABA-B receptor agonist. It dampens excitatory signalling in the spinal cord, which underlies its effect on spasticity. In the brain, GABAergic inhibition can also modulate dopaminergic and noradrenergic circuits.
Those circuits are involved in impulsivity, attention and tic-related symptoms, which is the plausible bridge to ADHD. The literature found is dominated by Tourette syndrome and tic-disorder reviews, which often discuss ADHD as a comorbidity. It also includes rodent studies on impulsivity and neurotransmitter agonists.
The support is therefore indirect. No ADHD-specific clinical evidence for baclofen is visible, and the 99.32% score is a model prediction only. The literature assessment is based on titles and truncated abstracts, not full texts.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
None of these are randomized trials. Reviews are listed first, then preclinical work.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 35345730 | 2022 | Review | Cureus | Tic disorders in Tourette’s syndrome (behavioural therapy, antipsychotics, alpha agonists). ADHD appears as a common comorbidity. |
| 26366961 | 2015 | Review | Clinical Neuropharmacology | Mood stabilizers in children and adolescents with autism spectrum disorders. Covers irritability and attention-deficit behaviours. |
| 24295630 | 2013 | Review | International Review of Neurobiology | Emerging treatments in Tourette syndrome, with ADHD and OCD as comorbid conditions. |
| 11393328 | 2001 | Review | Paediatric Drugs | Clinical features and management of Tourette syndrome, including psychiatric comorbidity. |
| 10342599 | 1999 | Review (as classified) | Journal of Child Neurology | Reports treating 450 patients with tics/Tourette’s using baclofen and botulinum toxin A, rated on the Yale Global Tic Severity Scale. It concerns tics, not ADHD. |
| 30122296 | 2019 | Off-label prescribing report | L’Encephale | Supervised off-label methylphenidate in adult ADHD. It is not about baclofen and is only context. |
| 21300040 | 2011 | Preclinical (rodent EEG) | Brain Research | EEG responses to neurotransmitter agonists in spontaneously hypertensive (ADHD model) versus kainate-treated rats. |
| 24062084 | 2014 | Preclinical (rodent) | Psychopharmacology | Alpha-2A adrenergic stimulation in the ventral hippocampus reduces impulsive decision-making. The drug studied is guanfacine. |
| 24103016 | 2013 | Preclinical (rodent) | European Journal of Neuroscience | Habenula function and social play behaviour in rats, involving monoaminergic regulation. |
| 24496320 | 2014 | Preclinical (rodent) | Neuropsychopharmacology | Anterior cingulate cortex and basolateral amygdala roles in effort-based decision-making. |
US Market Information
The Evidence Pack lists 20 licenses in total. The first 5 entries include a duplicate of ANDA212378, so 4 distinct authorizations are shown. All are generics, and the approved-indication text is not provided.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ANDA209102 | Baclofen (Direct_Rx) | Tablet | Not stated in data |
| ANDA211659 | Baclofen (A-S Medication Solutions) | Tablet | Not stated in data |
| ANDA214374 | Baclofen (Rising Pharma Holdings, Inc.) | Tablet | Not stated in data |
| ANDA212378 | Baclofen (Bryant Ranch Prepack) | Tablet | Not stated in data |
Injectable baclofen is also recorded among the dosage forms, alongside the oral tablet.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The ADHD prediction rests on a model score and indirect evidence (tic-disorder reviews and rodent studies). There is no ADHD-specific clinical trial or human study of baclofen, so this is an L4, stage S0 candidate.
To proceed, the following is needed:
- ADHD-specific human evidence, such as registered trials or case series of baclofen in ADHD
- Full-text review of the literature (only titles and truncated abstracts were assessed)
- Mechanism of action data (DrugBank MOA) to support the GABA-B, dopamine and noradrenaline link
- Package insert warnings and contraindications, needed before any safety screening
- Route and dosage-form compatibility assessment for a pediatric and adult ADHD population
Note on the second predicted indication: the same Evidence Pack also lists nicotine dependence (TxGNN score 99.19%). It has three Phase 2 trials (one completed, n=44; two terminated early, n=41 and n=6), rodent evidence and a Phase 2/RCT-level literature base. It is rated L2, stage S1, “Research Question”, and is a much stronger candidate than ADHD if the team wants to prioritise baclofen repurposing.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.