Buprenorphine
| Evidence Level: L4 | Predicted Indications: 6 |
Table of Contents
- Buprenorphine
- Pharmacist Assessment Report
- Buprenorphine: From Opioid Dependence to Acute Intermittent Porphyria
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Safety Considerations
- Other Predicted Indications (Context)
- Conclusion and Next Steps
- Disclaimer
Buprenorphine: From Opioid Dependence to Acute Intermittent Porphyria
One-Sentence Summary
Buprenorphine is a partial opioid agonist originally used to treat opioid dependence and related substance dependence disorders. The TxGNN model predicts it may be effective for Acute Intermittent Porphyria, but there are 0 clinical trials and only 1 publication (an anesthetic case report) behind this prediction. The evidence is weak, and the high model score is not supported by clinical data.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Opioid dependence, substance abuse/dependence, morphine dependence (approved indication text is not available in the India licence records) |
| Predicted New Indication | Acute intermittent porphyria |
| TxGNN Prediction Score | 0.9941 |
| Evidence Level | L4 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, buprenorphine is a mu-opioid partial agonist used in opioid dependence and pain management. Its efficacy in opioid dependence is established, but no mechanistic basis for use in acute intermittent porphyria has been identified.
Acute intermittent porphyria is caused by a defect in heme biosynthesis. There is no credible mechanistic link between mu-opioid partial agonism and this defect. The only publication found is a report on anesthetic management of a patient with the disease. It suggests opioid-type analgesia may be usable in these patients, but it does not show any disease-modifying benefit.
The high TxGNN score (0.9941) is therefore not backed by clinical data. At most, buprenorphine could serve as symptomatic analgesia, and this would require checking porphyria safety first, including porphyrinogenic drug lists and CYP3A4 metabolism of buprenorphine.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 8301837 | 1993 | Case report | Masui (Japanese Journal of Anesthesiology) | Anesthetic management of a 40-year-old woman with suspected acute intermittent porphyria undergoing surgery for ovarian tumour; no evidence of disease-modifying benefit |
India Market Information
Twenty valid single-ingredient registrations are on record. Approved indication text is not available for any of them. The main authorizations are:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 26263 | Bupreplast Patch (Zuventus Healthcare) | Box of 2 patches | Not specified |
| 139468 | Mutrans 20mcg/hr Transdermal Patch (6ipain Healthcare) | Box of 2 transdermal patches | Not specified |
| 25826 | Buvalor 10mg Transdermal Patch (Modi Mundi Pharma) | Packet of 2 transdermal patches | Not specified |
| 28578 | Buprinor 0.3mg Injection (AstraZeneca) | Vial of 2 ml injection | Not specified |
| 216369 | Tidigesic 0.2mg Tablet (Sun Pharmaceutical) | Strip of 10 tablets | Not specified |
Available forms include transdermal patches, injections and tablets.
Safety Considerations
- Contraindications (from TxGNN model associations, not label text): The TxGNN model (deep learning) links buprenorphine to a number of conditions, which may reflect similarities the model learned between related diseases, not biological evidence, including:
- Respiratory: chronic obstructive pulmonary disease, respiratory failure
- Cardiac and circulatory: long QT syndrome, torsades de pointes, orthostatic hypotension
- Hepatic: liver disease, chronic hepatitis B and C infection
- Gastrointestinal: paralytic ileus, intestinal obstruction, gallbladder disease
- Endocrine: hypothyroidism, adrenocortical insufficiency (Addison disease)
- Other: benign prostatic hyperplasia, intracranial hypertension, urethral stricture
- Drug Interactions: 264 interactions were recorded. Major-level interactions include:
- Alvimopan
- Bupropion
- Morphine
- Cisapride
- Dolasetron
Moderate-level interactions include famotidine, loperamide, aprepitant, clarithromycin, cimetidine and several anticholinergics.
- Porphyria-specific caution: Porphyria safety of buprenorphine, including CYP3A4 metabolism, has not been verified and must be checked before any use in this condition.
Please refer to the package insert for label warnings and contraindications, as these were not available in the data compiled for this report.
Other Predicted Indications (Context)
None of the other top-ranked predictions has supporting trials. All are rated Hold.
| Rank | Predicted Indication | TxGNN Score | Evidence Level | Comment |
|---|---|---|---|---|
| 2 | Lingual-facial-buccal dyskinesia | 0.9932 | L5 | Literature is indirect (opioids and agitation in dementia, pharmacology, veterinary safety); none addresses dyskinesia. Opioids may themselves cause movement-related adverse effects. |
| 3 | Chronic tic disorder | 0.9913 | L5 | Model prediction only |
| 4 | Continuous spikes and waves during sleep | 0.9905 | L5 | Model prediction only; opioids can lower seizure threshold in some settings |
| 5 | Extrapyramidal and movement disease | 0.9903 | L5 | Broad category; model prediction only |
| 6 | Benign shuddering attacks | 0.9903 | L5 | Benign, self-limiting paediatric condition; the risk-benefit of an opioid would be unfavourable |
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on a single anesthetic case report with no clinical trials, and there is no plausible mechanistic link between buprenorphine and the heme biosynthesis defect in acute intermittent porphyria. Any use would be symptomatic analgesia only, and porphyria-related safety is unresolved.
To proceed, the following is needed:
- Mechanism of action data for buprenorphine (for example from DrugBank)
- Package insert warnings and contraindications from the India regulatory records, and approved indication text for the registered products
- Review of buprenorphine against porphyrinogenic drug lists, including the effect of CYP3A4 metabolism
- Evidence of disease-modifying benefit, or a clear decision to pursue only a symptomatic analgesia use case, supported by controlled clinical data
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.