Hydromorphone
| Evidence Level: L5 | Predicted Indications: 6 |
Table of Contents
Hydromorphone: From Opioid Pain Relief to Pharyngitis
One-Sentence Summary
Hydromorphone is a mu-opioid pain medicine that is widely marketed in the US as tablets, extended-release tablets and injections. The TxGNN model predicts it may be effective for pharyngitis, but no trial or publication studies it for that condition. The 6 registered trials that matched the query are all about post-surgical pain (mainly after tonsillectomy) or other diseases, and there is no directly relevant literature.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Pharyngitis |
| TxGNN Prediction Score | 99.81% |
| Evidence Level | L5 (no study tests hydromorphone in pharyngitis; the pipeline’s automatic scoring shows L4) |
| US Market Status | ✓ Marketed |
| Number of NDAs | 20 |
| Recommended Decision | Hold |
The US approved-indication text is empty for all listed licenses, so the original indication is not shown here.
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the source record. In general, hydromorphone is a mu-opioid agonist that gives central pain relief. It has no anti-infective or anti-inflammatory action against pharyngitis.
The high TxGNN score most likely reflects closeness in the knowledge graph between hydromorphone and throat or pain nodes, not a treatment effect. At most, hydromorphone might give nonspecific pain relief for a sore throat. Opioids are not a rational treatment for pharyngitis, which is usually a self-limiting infection.
The only related trial data concern pain after tonsillectomy, which is postoperative pain, not pharyngitis. The prediction should therefore be read as a low-confidence model output.
Clinical Trial Evidence
None of these trials tests hydromorphone in pharyngitis. Only one (NCT04230681) tests hydromorphone directly, and it studies postoperative pain. The rest are incidental matches.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT04230681 | Early Phase 1 | Completed | 189 | Hydromorphone vs fentanyl for pain control in children after tonsillectomy or adenotonsillectomy. The most relevant trial, but it addresses postoperative pain, not pharyngitis. No results provided. |
| NCT05244226 | Phase 2 | Completed | 66 | Pilot comparing short-acting opioids (fentanyl/hydromorphone) with methadone for pediatric tonsillectomy pain. Hydromorphone is a comparator only. |
| NCT06576830 | Phase 4 | Recruiting | 440 | Intraoperative methadone vs short-acting opioids (fentanyl/hydromorphone) for pain after pediatric tonsillectomy. |
| NCT02996591 | Phase 4 | Completed | 36 | Spinal vs general anesthesia with nerve blocks for foot and ankle surgery. Unrelated to pharyngitis. |
| NCT00189488 | Phase 2 | Completed | 155 | Palifermin to reduce graft-versus-host disease and oral mucositis after transplant. Different disease. |
| NCT00109031 | Phase 3 | Completed | 47 | Single-dose vs 3-dose palifermin for oral mucositis after high-dose chemotherapy and irradiation. No hydromorphone efficacy signal. |
Literature Evidence
Currently no related literature available.
US Market Information
| Authorization Number | Product Name | Dosage Form |
|---|---|---|
| NDA019892 | Hydromorphone Hydrochloride (Rhodes Pharmaceuticals L.P.) | Tablet |
| NDA200403 | Hydromorphone Hydrochloride (Hospira, Inc.) | Injection, solution |
| ANDA204278 | Hydromorphone Hydrochloride (Padagis US LLC) | Tablet, extended release |
| ANDA205814 | Hydromorphone Hydrochloride (Aurolife Pharma, LLC) | Tablet |
| ANDA212133 | Hydromorphone Hydrochloride (Camber Pharmaceuticals, Inc.) | Tablet, extended release |
The oral and injectable forms above are 5 of the 20 licenses on file.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on a model score alone. No trial or publication supports hydromorphone for pharyngitis, and the mechanism gives only nonspecific pain relief. Opioids are not a rational treatment for this usually self-limiting condition, so repurposing is not justified on current evidence.
To proceed, the following is needed:
- A clear rationale for why hydromorphone would treat pharyngitis, beyond symptomatic pain relief
- Mechanism of action data
- Package insert warnings and contraindications, which are still missing and block safety screening
- Any pharyngitis-specific clinical or literature evidence, which is currently absent
Among the other predicted indications for hydromorphone, headache disorder has the most evidence: a completed Phase 4 head-to-head RCT in acute migraine (NCT02389829) and several related publications. It is also on Hold, because the literature suggests hydromorphone serves as a comparator rather than a preferred therapy, and opioids carry dependence, medication-overuse headache and return-visit risks.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.