Last reviewed · How we verify
Anti-Epileptic Drug (AED)
Vagus nerve stimulation (VNS) delivers electrical pulses to the vagus nerve to modulate brain activity and reduce seizure frequency.
Vagus nerve stimulation (VNS) delivers electrical pulses to the vagus nerve to modulate brain activity and reduce seizure frequency. Used for Adjunctive therapy for refractory partial-onset seizures in patients ≥4 years old, Adjunctive therapy for generalized seizures.
At a glance
| Generic name | Anti-Epileptic Drug (AED) |
|---|---|
| Also known as | Mysoline® is a registered trademark of Valeant Pharmaceuticals, Neurotin® is registered trademark of Pfizer, Inc, Vimpat® is a registered trademark of UCB Pharma, Tegretol® is a registered trademark of Novartis Pharmaceuticals |
| Sponsor | Cyberonics, Inc. |
| Drug class | Neurostimulation device / Vagus nerve stimulator |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | FDA-approved |
Mechanism of action
The device stimulates the left vagus nerve with programmed electrical pulses, which transmit signals to multiple brain regions involved in seizure generation and control. This neuromodulation approach alters abnormal electrical activity patterns associated with epilepsy. The exact mechanism is not fully understood but involves effects on neurotransmitter systems and seizure threshold elevation.
Approved indications
- Adjunctive therapy for refractory partial-onset seizures in patients ≥4 years old
- Adjunctive therapy for generalized seizures
Common side effects
- Voice alteration / hoarseness
- Cough
- Dyspnea
- Neck pain
- Infection at implant site
- Device malfunction / lead fracture
Key clinical trials
- Seizure Treatment in Glioma (PHASE4)
- A Study to Investigate How Effective, Safe and Tolerable the Drug NBI-921352 is When Used With Anti-seizure Medications in Adults With Focal Onset Seizures (PHASE2)
- To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE) (PHASE3)
- Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures (PHASE3)
- Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures (PHASE2)
- A Post-marketing Observational Study Of The Use Of Zonisamide (ZNS) in the Adjunctive Treatment Of Adult Patients With Partial Onset Seizures (Study E2090-E044-410) (ZOOM)
- Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension (PHASE3)
- Inflammatory Biomarkers in Seizure
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Anti-Epileptic Drug (AED) CI brief — competitive landscape report
- Anti-Epileptic Drug (AED) updates RSS · CI watch RSS
- Cyberonics, Inc. portfolio CI