ElectroCore’s non-invasive vagus nerve stimulation therapy shown to be safe and to produce no meaningful cardiac adverse effects
The open-label trial which was carried out at four centers across the US[2] involved 284 ECGs being performed on 29 patients with a history of mild-to-moderate asthma. Each patient had a 12-lead electrocardiograms 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.
GammaCore treatment, which is self-administered by the patient for 120 seconds at home or anywhere else, involves placing the 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, 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. Initial focus is primary headache.
ElectroCore, has raised more than $80 million from investors including Merck’s Global Healthcare Innovation fund.
[1] 12-month open-label study in March 2015 Neurology journal. Led by Professor Peter Goadsby conducted at the Royal Free Hospital in London and the Beaumont Hospital, Dublin.
[2] Trial sites; Allergy and Asthma Specialist Dr Harold Kaiser, Minneapolis; Allergy, Asthma and Immunology Center, Tulsa; Allergy & Asthma Medical Group & Research Center, San Diego; Colorado Allergy & Asthma Center, Denver
Website: http://www.electrocoremedical.com
Contact
ElectroCore
Simon Vane Percy
+44 (0) 1737 821890
simon@vanepercy.com
This news is a press release provided by ElectroCore.
-
2015년 5월 19일 15:00