Buprenorphine
| Evidence Level: L4 | Predicted Indications: 6 |
Table of Contents
Buprenorphine: From Opioid Therapy to Acute Intermittent Porphyria
One-Sentence Summary
Buprenorphine is a marketed opioid drug with 20 US authorizations, and the pack does not list its approved indication text. The TxGNN model predicts it may be effective for acute intermittent porphyria, but the evidence is very thin: 0 clinical trials and 1 publication, a 1993 anesthesia case report that does not test the drug as a treatment.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Acute intermittent porphyria |
| TxGNN Prediction Score | 99.41% |
| 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. Based on known information, buprenorphine is an opioid, and the retrieved pharmacology literature describes it as a mu-opioid partial agonist with antagonist properties. No mechanistic pathway linking these properties to acute intermittent porphyria (AIP) has been established.
The relationship between the original use and AIP is also unclear. The only retrieved article is a case report on anesthetic management of a patient with suspected AIP. It concerns perioperative safety, not treatment of the disease. The high TxGNN score (0.994) is a computational prediction from the knowledge graph. It should not be read as clinical support.
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 AIP who underwent surgery for a malignant ovarian tumor before her porphyria tests came back. It addresses perioperative safety, not disease treatment. |
US Market Information
| Authorization Number | Product Name | Dosage Form |
|---|---|---|
| ANDA211586 | Buprenorphine (Amneal Pharmaceuticals NY LLC) | Extended-release patch |
| ANDA090622 | Buprenorphine hydrochloride (RemedyRepack Inc.) | Tablet |
| ANDA078633 | Buprenorphine (Major Pharmaceuticals) | Tablet |
| NDA021306 | Butrans (Purdue Pharma LP) | Extended-release patch |
| ANDA201760 | Buprenorphine (AvPAK) | Tablet |
Other available forms across all 20 authorizations include soluble film and injection.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The AIP prediction has no registered trials and only one tangential case report, so it rests almost entirely on the model score. The pack also lacks basic drug-level data (mechanism of action, package insert warnings), so safety screening cannot start.
To proceed, the following is needed:
- Package insert warnings and contraindications (a blocking gap for safety screening)
- Detailed mechanism of action data, to test whether any plausible link to AIP exists
- Literature reviewed for actual therapeutic evidence in AIP, such as pain management in acute attacks, and a check of opioid safety in porphyria
- Confirmation of the approved indication text from the US labels
Other predictions: The five lower-ranked predictions also stay at Hold. They are lingual-facial-buccal dyskinesia, chronic tic disorder, continuous spikes and waves during sleep, extrapyramidal and movement disease, and benign shuddering attacks. None has clinical trials or supportive therapeutic literature. Several appear to share the same knowledge-graph signal, so they are not independent evidence.
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any application.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.