electroCore's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by electroCore (ECOR).
Over the past two years, electroCore has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
gammaCore. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
GammaCore nVNS FDA Regulatory Events
GammaCore nVNS is a drug developed by electroCore for the following indication: Acute and preventive treatment of migraine in adolescents between 12 and 17 years of age.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- gammaCore nVNS
- Announced Date:
- September 30, 2025
- Indication:
- Acute and preventive treatment of migraine in adolescents between 12 and 17 years of age
Announcement
electroCore, Inc. announced the publication of a peer-reviewed study in Frontiers in Neurology demonstrating the effectiveness of gammaCore® non-invasive vagus nerve stimulation (nVNS) in reducing persistent symptoms associated with mild traumatic brain injury (mTBI).
AI Summary
electroCore, Inc. announced the publication of a peer-reviewed study in Frontiers in Neurology showing that gammaCore® non-invasive vagus nerve stimulation (nVNS) can ease long-lasting symptoms after mild traumatic brain injury (mTBI). The study tested gammaCore alongside standard care and measured changes in patients’ post-concussion complaints.
In an observational trial of 102 adults with persistent mTBI symptoms, researchers found significant improvements in 16 of 22 Neurobehavioral Symptom Inventory categories. Participants reported fewer headaches, less dizziness, better concentration, and reduced depression. About 34% said at least half of their symptoms meaningfully improved. Benefits appeared whether treatment began within three months of injury or more than a year later. No device-related adverse events occurred.
Lead author Michael Ament, MD, noted this is the first larger prospective study suggesting that adding non-invasive vagus nerve stimulation to usual care may help people with ongoing mTBI symptoms.
Read Announcement- Drug:
- gammaCore nVNS
- Announced Date:
- September 29, 2025
- Indication:
- Acute and preventive treatment of migraine in adolescents between 12 and 17 years of age
Announcement
electroCore, Inc. announced that gammaCore™ Sapphire (nVNS) has been included in a long-term reimbursement policy launched by the National Institute for Health and Disability Insurance (RIZIV / INAMI) in Belgium.
AI Summary
electroCore, Inc. announced that gammaCore™ Sapphire, its non-invasive vagus nerve stimulation device, has been added to a long-term reimbursement policy by Belgium’s National Institute for Health and Disability Insurance (RIZIV/INAMI). Effective October 1, 2025, the policy covers gammaCore Sapphire for patients suffering from cluster headaches. Coverage was granted based on strong clinical evidence of the therapy’s efficacy and cost-effectiveness, ensuring that more Belgian patients can access this treatment.
Prof. Peter Paemeleire of Ghent University Hospital praised the decision, noting that non-invasive vagus nerve stimulation offers both clinical and economic benefits. He emphasized that wider reimbursement will help patients manage their daily lives more effectively while supporting a sustainable healthcare system.
Silvert Medical, electroCore’s distribution partner in Belgium, played a key role in securing this reimbursement through its local expertise and provider relationships. “Securing long-term reimbursement in Belgium is a major milestone,” said Tanja Martin, Senior Director of Strategic Product Lifecycle at electroCore. This achievement sets the stage for expanding access to gammaCore™ Sapphire across Europe.
Read Announcement
electroCore FDA Events - Frequently Asked Questions
As of now, electroCore (ECOR) has not received any FDA approvals for its therapy in the last two years.
In the past two years, electroCore (ECOR) has reported FDA regulatory activity for gammaCore nVNS.
The most recent FDA-related event for electroCore occurred on September 30, 2025, involving gammaCore nVNS. The update was categorized as "Publication," with the company reporting: "electroCore, Inc. announced the publication of a peer-reviewed study in Frontiers in Neurology demonstrating the effectiveness of gammaCore® non-invasive vagus nerve stimulation (nVNS) in reducing persistent symptoms associated with mild traumatic brain injury (mTBI)."
Currently, electroCore has one therapy (gammaCore nVNS) targeting the following condition: Acute and preventive treatment of migraine in adolescents between 12 and 17 years of age.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ECOR) was last updated on 10/1/2025 by MarketBeat.com Staff
