Nitrous Oxide
| Evidence Level: L4 | Predicted Indications: 1 |
Table of Contents
Nitrous Oxide: From Anesthesia and Analgesia to Benign Prostatic Hyperplasia
One-Sentence Summary
Nitrous oxide is an inhaled gas widely used as an anesthetic and analgesic. The TxGNN model predicts it may be effective for benign prostatic hyperplasia (BPH), but only 1 clinical trial and 1 publication are linked to this prediction, and neither tests BPH treatment. The evidence is weak and the prediction is not supported by a plausible mechanism.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not specified in the US license records compiled for this report |
| Predicted New Indication | Benign prostatic hyperplasia |
| TxGNN Prediction Score | 99.52% |
| Evidence Level | L4 |
| US Market Status | Cancelled only |
| Number of NDAs | 3 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available for this drug in the data compiled for this report. Nitrous oxide is generally understood as an inhaled anesthetic and analgesic with NMDA receptor antagonism and anxiolytic effects.
The review found no credible mechanistic link between nitrous oxide and BPH. It has no known action on prostate growth, androgen signaling, or prostate smooth muscle tone. The very high TxGNN score (0.995) is a model output and is not backed by pharmacological rationale or clinical data showing disease modification.
The only clinical connection is procedural. Nitrous oxide has been used to reduce anxiety and pain during prostate-related procedures, which is not treatment of BPH itself. The prediction should be treated with caution.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT05803096 | Phase 4 | Completed | 143 | Self-administered nitrous oxide during transrectal prostate biopsy to reduce anxiety and pain. It addresses procedural comfort, not BPH, and the population is not defined by BPH. It suggests feasibility of use in urologic procedures only. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 9223887 | 1997 | Case report | Masui (Japanese Journal of Anesthesiology) | Anesthetic management of a patient with pure autonomic failure undergoing suprapubic prostatectomy. It concerns anesthesia technique, not BPH treatment. |
US Market Information
All three listed authorizations are cancelled, and no approved indication text is recorded for them.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| NDA206009 | Nitrous Oxide | Gas | Not recorded |
| NDA209989 | Nitrous Oxide | Gas | Not recorded |
| NDA205704 | Nitrous Oxide | Gas | Not recorded |
Safety Considerations
- Drug Interactions: Five interactions were identified.
- Major: Methotrexate
- Moderate: Morphine, Opium, Codeine, Hydrocodone
Please refer to the package insert for other safety information, including warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The high TxGNN score is not supported by a plausible mechanism or by any study of BPH treatment. The one trial and one publication relate only to procedural anesthesia and anxiety. All US licenses are cancelled, and the key safety labeling information could not be obtained.
To proceed, the following is needed:
- Mechanism of action data and a plausible pharmacological rationale for an effect on BPH
- Preclinical or clinical studies that test BPH outcomes directly
- FDA package insert warnings and contraindications for a full safety review
- Clarification of the original approved indications and current regulatory status
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.