Lornoxicam
| Evidence Level: L5 | Predicted Indications: 8 |
Table of Contents
Lornoxicam: Migraine disorder
One-Sentence Summary
Lornoxicam is a nonsteroidal anti-inflammatory drug (NSAID) of the oxicam class that is marketed in India as single-ingredient products. The TxGNN model predicts it may be effective for migraine disorder. The evidence is thin: 1 completed Phase 2 trial has no published or posted results, and the 2 publications are reviews, so the evidence level is L5.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Migraine disorder |
| TxGNN Prediction Score | 0.9987 |
| Evidence Level | L5 |
| 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?
Lornoxicam inhibits both COX-1 and COX-2, which reduces prostaglandin synthesis. Detailed mechanism of action data is not available in the data compiled for this report, so this description reflects the general pharmacology of the drug class.
Prostaglandins contribute to neurogenic inflammation and trigeminovascular sensitization, which are central to migraine attacks. NSAIDs as a class are an established acute migraine therapy, so the mechanism is biologically plausible for lornoxicam.
This is a class-level rationale only. No published study tests lornoxicam itself in migraine, which is why the evidence level stays at L5 despite the high model score.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00293657 | Phase 2 | Completed | 150 | Randomized, double-blind, placebo-controlled single-dose study of intravenous lornoxicam (8 mg or 16 mg) versus placebo for moderate or severe headache during an acute migraine attack. Completed in 2006 with no published or posted results. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 1495823 | 1992 | Review | Pathologie-biologie | Reviews controlled studies of NSAIDs for acute and preventive migraine treatment. Lornoxicam is among the many NSAIDs listed. |
| 8706598 | 1996 | Review | Drugs | Reviews the pharmacology and therapeutic potential of lornoxicam in painful and inflammatory conditions. It is not a migraine-specific study. |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Registration No. 132637 | Lormyp 8mg/325mg Tablet | Strip of 10 tablets | Not stated in the records |
| Registration No. 126438 | Lodol 4mg Tablet | Strip of 10 tablets | Not stated in the records |
| Registration No. 250889 | Zoloxy 8mg Tablet | Strip of 10 tablets | Not stated in the records |
| Registration No. 131888 | Lornok 8mg Tablet | Strip of 10 tablets | Not stated in the records |
| Registration No. 232371 | Univer 4mg Tablet | Strip of 10 tablets | Not stated in the records |
At least 20 valid licences are on record, and the list may be partial.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The mechanism is plausible and the model score is high. However, the only trial in migraine (NCT00293657) has no published or posted results, and the available publications are reviews. No published study therefore tests lornoxicam in migraine, and the evidence level is L5.
To proceed, the following is needed:
- Results of NCT00293657, or a new controlled trial of lornoxicam in migraine
- Detailed mechanism of action data
- Package insert warnings and contraindications from the Indian licences
- Confirmation of the approved indication text on the local licences
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.