BASKING RIDGE, N.J - Tuesday, December 10th 2013 [ME NewsWire]
(BUSINESS WIRE) electroCore’s non invasive vagus nerve stimulation therapy for the prevention and treatment of cluster headache and migraine was reviewed at both the AHS Annual Scottsdale Headache Symposium (Nov 21st to 24th) and the NANS meeting this weekend (Dec 5th to 8th).
At both meetings there was significant interest in the platform presentations. The gammaCore clinical trial program, including two completed open label studies, as well as their four on-going randomized studies, was discussed in two platform presentations at each meeting.
Following a series of promising open label trials, electroCore is now well underway with the running of the four randomized clinical trials, two of which are being conducted under an US, Investigational Device Exemption (IDE) for both migraine and cluster headaches. The cluster study specifically is a pivotal, double blind, sham controlled study for submission to the FDA for approval.
electroCore, which is a US based electroceutical company, made a significant breakthrough when it developed a non invasive vagus nerve stimulation device called gammaCore. Surgically implanted VNS has been proven over twenty years, and in more than 100,000 patients to be an effective and safe therapy for the treatment of refractory epilepsy and depression. However the high cost and invasiveness of implanted pacemaker-like devices have relegated VNS therapy to the end of the continuum of care.
Dr Stewart Tepper, Director of Research for the Center for Headache and Pain at the Cleveland Clinic commented, ”Non-Invasive VNS could represent a novel and possibly significant new treatment for cluster headaches and migraine. I look forward to seeing the results from the four Randomized Clinical Trials now underway that should report their findings over the next year.”
The great benefits of non invasive VNS is that it can be self administered by the patient through individual two minute doses; it can be used in conjunction with other medications; is well tolerated and is believed to stimulate the production of the body’s own inhibitory neurotransmitters which reduces the over expression of the excitatory neurotransmitter glutamate, which has been implicated in a number of different disorders including headache.
electroCore is working with headache specialists in the UK, Germany, Australia and Canada, where already it has CE approval, to successfully treat patients with gammaCore. In the US the pivotal trial to support a PMA application is already underway.
Vane Percy & Roberts