Duloxetine
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Duloxetine
- Duloxetine: From Approved Depression and Pain Indications to Benign Paroxysmal Torticollis of Infancy
Duloxetine: From Approved Depression and Pain Indications to Benign Paroxysmal Torticollis of Infancy
One-Sentence Summary
Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant. It is approved for conditions such as major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and fibromyalgia. The TxGNN model predicts it may be effective for benign paroxysmal torticollis of infancy, but no clinical trials and no publications currently support this prediction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not listed in the US license records. Published literature describes approval for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain |
| Predicted New Indication | Benign paroxysmal torticollis of infancy |
| TxGNN Prediction Score | 99.85% |
| Evidence Level | L5 |
| 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 in the Evidence Pack. Duloxetine is known to inhibit serotonin and norepinephrine reuptake. This has proven benefit in depression, anxiety, and chronic pain, but it has no established role in this condition.
Benign paroxysmal torticollis of infancy is a paroxysmal disorder of early childhood. It is related to migraine and to CACNA1A channelopathy. No plausible link between duloxetine’s pharmacology and this condition was identified. The high score reflects a knowledge-graph prediction only, with no supporting clinical or mechanistic evidence. Use in infants would also raise additional safety concerns.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA203197 | Duloxetine | Capsule, delayed release | Ascend Laboratories, LLC |
| ANDA090694 | Duloxetine | Capsule, delayed release | A-S Medication Solutions |
| NDA212516 | DRIZALMA SPRINKLE | Capsule, delayed release | Sun Pharmaceutical Industries, Inc. |
| ANDA090694 | Duloxetine | Capsule, delayed release | RemedyRepack Inc. |
| ANDA090694 | Duloxetine | Capsule, delayed release | NCS HealthCare of KY, LLC dba Vangard Labs |
All listed products are oral. The records contain no approved-indication text.
Safety Considerations
Please refer to the package insert for safety information. Any use in infants would need dedicated pediatric safety evaluation.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on the knowledge-graph score. There are no clinical trials or literature, no plausible mechanism, and infant use raises safety concerns.
To proceed, the following is needed:
- A credible mechanistic rationale linking SNRI pharmacology to this condition
- Package insert warnings and contraindications, which are needed before any safety screening
- Any preclinical or clinical signal specific to this condition
Other candidates in the same prediction set: For obsessive-compulsive disorder (rank 3), the pack lists a Phase 4 duloxetine study (NCT00464698), a small double-blind augmentation RCT (PMID 27811556), and open-label studies. It is rated L2 and is a much better-supported direction than this one. It deserves its own evaluation report.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.