Brivaracetam
| Evidence Level: L3 | Predicted Indications: 10 |
Table of Contents
Brivaracetam: From Focal Seizures to Visual Epilepsy
One-Sentence Summary
Brivaracetam is an antiseizure medication marketed in the US for focal-onset seizures. The TxGNN model predicts it may be effective for visual (photosensitive) epilepsy. There are no registered clinical trials for this indication, and the 18 linked publications are mostly general epilepsy reviews. The closest human data are two photosensitivity-model studies (PMIDs 17785672 and 32949370), which use an EEG surrogate endpoint.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Focal-onset seizures (the license indication text in the pack is empty, so this comes from the pack’s rationale text) |
| Predicted New Indication | Visual epilepsy |
| TxGNN Prediction Score | 99.51% |
| Evidence Level | L3 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 20 licenses (NDA and ANDA) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Brivaracetam is a high-affinity ligand of synaptic vesicle protein 2A (SV2A), the target of levetiracetam. It binds SV2A with roughly 15 to 30 times higher affinity than levetiracetam and enters the brain quickly. By modulating synaptic vesicle release, it dampens neuronal hyperexcitability.
Visual epilepsy is a reflex epilepsy in which seizures are triggered by visual stimuli such as flickering light. Like focal epilepsy, it is a disorder of cortical hyperexcitability, so an SV2A ligand is mechanistically plausible. Brivaracetam has also been tested in the human photosensitivity model. In this model, patients receive intermittent photic stimulation, and the photoparoxysmal EEG response (PPR) serves as a biomarker of efficacy.
Two limits apply. First, the PPR studies are surrogate-endpoint work, and the pack lists them under “audiogenic seizures” rather than under this indication. Their design and sample size cannot be confirmed from the pack. Second, the literature actually attached to this indication is general epilepsy material. No study shows that brivaracetam reduces seizures in patients with visual epilepsy.
Clinical Trial Evidence
Currently no related clinical trials registered for visual epilepsy.
For context, the second-ranked prediction, status epilepticus, has one completed trial: NCT07163572, IV brivaracetam vs levetiracetam in pediatric status epilepticus (n=152, phase not applicable, no results in the pack). It does not apply to visual epilepsy.
Literature Evidence
The first two rows below are the photosensitivity studies most relevant to this indication. The pack lists them under a different predicted indication.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 32949370 | 2020 | RCT (double-blind crossover) | CNS Drugs | Brivaracetam vs levetiracetam on how quickly the PPR is suppressed in photosensitive epilepsy patients. Both drugs eliminate the PPR in this model. Detailed results are not in the pack. |
| 17785672 | 2007 | Human photosensitivity model study | Neurology | Proof-of-principle assessment of brivaracetam activity in the photosensitivity model. Abstract truncated in the pack. |
| 38576178 | 2024 | Phase III RCT | Epilepsia Open | Adjunctive brivaracetam in adult Asian patients with uncontrolled focal-onset seizures. Indirect evidence, not specific to visual epilepsy. |
| 37483441 | 2023 | Systematic review / meta-analysis | Front Neurol | Safety and efficacy of brivaracetam in childhood epilepsy in general. |
| 38811492 | 2024 | Review | Adv Ther | Preclinical profile and clinical benefits of brivaracetam. SV2A affinity is 15 to 30 times that of levetiracetam. |
| 40568060 | 2025 | Review | J Epilepsy Res | Pharmacology, efficacy, and safety. Approved as adjunctive and monotherapy for focal-onset seizures. |
| 31195850 | 2019 | Review | Expert Rev Neurother | Efficacy and tolerability in focal epilepsy. |
| 32120063 | 2020 | Review | Neuropharmacology | Mechanisms of action of currently used antiseizure drugs. |
| 31937513 | 2020 | Pooled analysis | Epilepsy Behav | Safety and tolerability of adjunctive brivaracetam in focal seizures. |
| 26664121 | 2015 | Review | Neuropsychiatr Dis Treat | Profile of brivaracetam. It does not share levetiracetam’s inhibition of high-voltage Ca²⁺ channels and AMPA receptors. |
US Market Information
The pack gives no approved-indication text for these licenses. Five of 20 licenses are shown.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| NDA205838 | Briviact | Solution | UCB, Inc. |
| ANDA214921 | Brivaracetam | Tablet, film coated | Novadoz Pharmaceuticals LLC |
| ANDA214875 | Brivaracetam | Tablet | Apotex Corp. |
| ANDA218494 | Brivaracetam | Solution | PAI Holdings, LLC dba PAI Pharma |
| ANDA214501 | Brivaracetam | Tablet, film coated | Zydus Lifesciences Limited |
Available forms include oral tablets, oral solution, and injection.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is very high (99.51%), but no trial has tested brivaracetam in visual epilepsy. The only related human data are PPR surrogate-endpoint studies, and safety labeling has not yet been reviewed. Among this drug’s predictions, status epilepticus (rank 2) has more clinical support, including an IV formulation, a completed head-to-head trial, and systematic reviews. It would be a better candidate to prioritize.
To proceed, the following is needed:
- Full-text review of the two PPR studies (PMIDs 17785672 and 32949370) to confirm design, sample size, and effect size
- Evidence that PPR suppression translates into clinical seizure reduction in visual epilepsy
- Parsing of the FDA package insert for warnings and contraindications (a blocking gap)
- A review of the drug-interaction profile (the query returned no records)
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any clinical use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.