At the 67th American Academy of Neurology meeting in Washington, DC, last week a poster presentation showed that electroCore’s non-invasive vagus nerve stimulation (nVNS) therapy does not cause any meaningful cardiovascular adverse effects in patients with asthma. The poster presentation, reported on the cardiac effects of nVNS in asthma patients using nVNS to treat acute bronchospasm. This study further reinforces the safety of nVNS shown in other clinical trials1 and experience with more than 1500 patients.
The open-label trial which was carried out at four centers across the US2 involved 284 ECGs being performed on 29 patients with a history of mild-to-moderate asthma. Each patient had a 12-lead electrocardiograms (ECGs) performed at 3 study visits: baseline, stimulation, and follow-up. During the stimulation visit, ECGs were performed prior to, during, and ≤90 minutes after administration of a single 120-second VNS stimulation.
The results showed that there were no clinically significant ECG changes, either in isolated readings or in comparison to baseline. Treatment with nVNS had no meaningful effect on heart rate, PR interval, corrected QT interval, or QRS duration. These findings were reviewed by an independent cardiologist.
The easy to use gammaCore treatment, which is self-administered by the patient for 120 seconds at home or anywhere else, involves placing the small, hand-held device on the skin of the neck over the vagus nerve.
ElectroCore, which is presently seeking FDA approval for the treatment and prevention of cluster headache, currently has regulatory approval for the acute and/or prophylactic treatment of cluster headache, migraine and medication overuse headache in EU, South Africa, India, New Zealand, Australia, Colombia, Brazil, and Canada.
ElectroCore, which is based in New Jersey, is dedicated to developing nVNS self-administered therapies for the treatment of multiple conditions in neurology, psychiatry, gastroenterology and respiratory fields. The company’s initial focus is on the treatment of primary headaches (migraine and cluster headache), and the associated chronic co-morbidities of gastric motility, psychiatric, sleep, and pain disorders that drive disproportionately large direct and indirect costs within the healthcare system and society.
ElectroCore, has raised more than $80 million from investors including Merck’s Global Healthcare Innovation fund.
1 A twelve-month open-label study in the March 2015 issue of the journal Neurology led by Professor Peter Goadsby conducted at the Royal Free Hospital in London and the Beaumont Hospital in Dublin.
2 Trial sites; Allergy and Asthma Specialist Dr Harold Kaiser, Minneapolis, MN 55402; Allergy, Asthma and Immunology Center, PC, Tulsa, OK 74136; Allergy & Asthma Medical Group & Research Center, APC, San Diego, CA 92123; Colorado Allergy & Asthma Center, Denver, CO 80230