Lisdexamfetamine
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
- Lisdexamfetamine
- Pharmacist Assessment Report
- Lisdexamfetamine: From Attention Deficit Hyperactivity Disorder to Specific Developmental Disorder
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Australia Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Lisdexamfetamine: From Attention Deficit Hyperactivity Disorder to Specific Developmental Disorder
One-Sentence Summary
Lisdexamfetamine is a prodrug of d-amphetamine. The TxGNN model predicts it may be useful for specific developmental disorder, but there are no registered clinical trials and 2 publications, neither of which studies this condition directly.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Attention deficit hyperactivity disorder, ADHD (inattentive type) and binge eating disorder (relations recorded in the knowledge graph; the Australian licence record contains no indication text) |
| Predicted New Indication | Specific developmental disorder |
| TxGNN Prediction Score | 1.0000 |
| 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?
Detailed mechanism of action data is not available in the data compiled for this report. Lisdexamfetamine is known to be converted in the body to d-amphetamine, which increases dopamine and noradrenaline signalling in prefrontal and striatal circuits and supports attention and executive function.
ADHD is a neurodevelopmental condition that overlaps with this symptom domain. “Specific developmental disorder” is a broad, heterogeneous label, so the link to the original use is indirect. The mechanism may be relevant to attention-related symptoms, but this is a hypothesis and not a demonstrated effect.
The retrieved publications do not directly study this condition (see below), so the evidence level is L5.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 31718254 | 2020 | RCT (Phase II/III) | J Child Adolesc Psychopharmacol | Randomised, double-blind, placebo-controlled study of lisdexamfetamine 30, 50 or 70 mg/day for 4 weeks in 76 Japanese children and adolescents with ADHD. It concerns ADHD, the original use, and is not direct evidence for the predicted condition. |
| 37849578 | 2023 | Case report | Cureus | Hao-Fountain syndrome presenting like fragile X syndrome in an 18-year-old with intellectual disability and ADHD. It describes a diagnostic differential, not a treatment effect. |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 10474G | Vyvanse | Capsule containing lisdexamfetamine dimesilate 50 mg | Not stated in the licence record |
Safety Considerations
Safety information from the product label is not available in the data compiled for this report. Please refer to the TGA-approved Product Information (PI) for warnings and contraindications.
- Relations recorded in the knowledge graph (not label text): contraindication relations are recorded for hypertension, coronary artery disease, myocardial infarction, stroke and cerebrovascular disorders, atherosclerosis, sudden cardiac arrest, heart conduction disease, epilepsy, bipolar disorder, psychotic and schizoaffective disorders, substance-related disorders, hyperthyroidism, glaucoma and vision disorders.
- Drug Interactions: 100 interactions were found in total. Major-level interactions in the listed entries include bupropion, dolasetron, cisapride and dexfenfluramine. Many others are Moderate, such as epinephrine, clarithromycin, levofloxacin, famotidine, and antacids or laxatives (for example aluminium hydroxide, calcium carbonate and magnesium oxide).
Conclusion and Next Steps
Decision: Hold
Rationale: The TxGNN score is very high, but no study directly addresses specific developmental disorder. The only trial is in ADHD, the original use, so the evidence level is L5. The category is also broad and the mechanistic link is indirect.
To proceed, the following is needed:
- A precise definition of which developmental disorder is meant, since the label is too broad to assess
- Mechanism of action data from DrugBank
- TGA Product Information warnings and contraindications to complete safety screening
- Controlled clinical evidence in the specific target population
- Review of the knowledge graph’s cardiovascular, psychiatric and substance-related contraindication relations against the target population
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.