Baclofen
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
Baclofen: GABA-B receptor agonist → attention deficit-hyperactivity disorder
One-Sentence Summary
Baclofen is a GABA-B receptor agonist available in Australia as an intrathecal injection. The TxGNN model predicts it may be useful for attention deficit-hyperactivity disorder, but the data compiled for this report contain no clinical trials and 9 publications, none of which test baclofen in this condition. The prediction is therefore supported by the model alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Attention deficit-hyperactivity disorder |
| TxGNN Prediction Score | 0.9932 |
| Evidence Level | L5 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Baclofen is a GABA-B receptor agonist. A plausible link to ADHD is through GABAergic inhibitory control over the dopaminergic and glutamatergic circuits involved in impulsivity and attention. Detailed mechanism of action data are not otherwise available in the data compiled for this report.
This link is hypothetical. The supplied publications do not test baclofen in ADHD. They are mainly reviews of Tourette syndrome treatment, studies of alpha-2 adrenergic mechanisms, and rodent studies of impulsivity, social play and decision-making. One paper describes off-label methylphenidate use in adult ADHD, and it does not involve baclofen. The very high TxGNN score is a computational output and is not backed by direct clinical or mechanistic evidence for baclofen in ADHD.
Literature Evidence
None of these papers directly studies baclofen in ADHD. They are listed to show the context of the prediction.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 35345730 | 2022 | Review | Cureus | Behavioural, antipsychotic and alpha-agonist treatment of tics in Tourette syndrome; ADHD mentioned as a common comorbidity |
| 24295630 | 2013 | Review | Int Rev Neurobiol | Emerging treatments for Tourette syndrome, including its behavioural comorbidities such as ADHD |
| 11393328 | 2001 | Review | Paediatr Drugs | Clinical features and management of Tourette syndrome, including comorbid psychiatric conditions |
| 10342599 | 1999 | Review | J Child Neurol | Baclofen with botulinum toxin type A in 450 patients with tics or Tourette syndrome; ADHD was not the target condition |
| 30122296 | 2019 | Clinical practice report | L’Encephale | Supervised off-label methylphenidate prescribing in adult ADHD; does not involve baclofen |
| 21300040 | 2011 | Preclinical (animal EEG) | Brain Res | EEG responses to neurotransmitter agonists in a rat model of ADHD and in a rat epilepsy model |
| 24062084 | 2014 | Preclinical (rodent) | Psychopharmacology | Guanfacine (alpha-2A agonist) in the ventral hippocampus reduced impulsive decision-making |
| 24496320 | 2014 | Preclinical (rodent) | Neuropsychopharmacology | Roles of anterior cingulate cortex and basolateral amygdala in effort-based decision-making |
| 24103016 | 2013 | Preclinical (rodent) | Eur J Neurosci | Habenula integrity is needed for social play behaviour in rats |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 11126N | Sintetica Baclofen Intrathecal | Intrathecal injection 10 mg in 5 mL | Not recorded in the local data |
Safety Considerations
- Drug Interactions: Interaction screening returned 100 records. Major interactions include morphine and liposomal morphine. Moderate interactions include dronabinol, nabilone, metoclopramide, opium, sibutramine, difenoxin and diphenoxylate. These are central nervous system depressants or agents with overlapping effects, so combined use needs clinical review.
For warnings and contraindications, please refer to the TGA-approved Product Information (PI).
Conclusion and Next Steps
Decision: Hold
Rationale: No clinical trial or publication in the data compiled for this report studies baclofen in ADHD, so the evidence level is L5. The high TxGNN score alone does not justify progression.
To proceed, the following is needed:
- Clinical studies or systematic reviews of baclofen in ADHD, and preclinical work on GABA-B modulation of attention and impulsivity
- Detailed mechanism of action data
- TGA Product Information warnings and contraindications for safety screening, noting that the only listed product is an intrathecal injection and that route compatibility with this use has not been assessed
- A safety review for the neuropsychiatric population, given the DDI signals above
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.