ElectroCore developing headache-relief device, targeting 2015 U.S approval
BASKING RIDGE, N.J. — Preliminary results of an open-label trial carried Thursday in the journal of Headache and Pain reported that a single treatment with ElectroCore’s hand held non-invasive vagus nerve stimulation device GammaCore, completely resolved 44.8% of migraines within 30 minutes, with an additional 11.4% experiencing moderate benefits (incomplete resolution of their headaches) by two hours.
This result follows two presentations at the International headache meeting in Copenhagen in September showing that patients using GammaCore achieved a 43.4% reduction in the number of weekly cluster headache attacks compared with 12.5% in patients treated with the best available standard of care. It also found that patients experienced a greater reduction in number of attacks the longer they stayed on treatment.
“As the results of our studies continue to demonstrate positive results, we are increasingly optimistic that the extensive investment we have made in both pre-clinical trials and clinical trials was a wise use of our capital and human resources," stated JP Errico, ElectroCore CEO. "We believe that this therapy is unique in both its safety and efficacy profiles. With few adverse events reported, non-invasive vagus nerve stimulation appears to be the first therapeutic option that offers both acute and prophylactic benefits for patients who suffer frequent and severe headaches. As such, we believe that GammaCore will ultimately move to a first line treatment for these patients, and will continue to conduct the clinical research necessary to support that conclusion.”
The open-label migraine study was carried out at the Headache Center in the Neurological Institute in Milan, Italy. The study involved thirty patients, ages 18 years to 65 years, who had migraine without aura and suffered from five to nine attacks per month. Patients treated from three to six migraine episodes with gammaCore. Ninety-six migraine attacks were treated by a single dose. Forty three attacks were resolved completely within 30 minutes (44.8%); for 42 (43.7%) attacks the application did not show any benefit in the first two hours so patients recurred to rescue medication; in 11 (11.4%) attacks the result was uncertain: no resolution of attack, only a moderate relief of pain. No adverse events were recorded.
In Europe, ElectroCore’s nVNS technology has a CE mark for primary headache, bronchoconstriction, epilepsy, gastric motility disorders, and depression and anxiety. It also has regulatory approval for the acute and/or prophylactic treatment of cluster headache, migraine and medication overuse headache in South Africa, India, New Zealand, Australia, Colombia, Brazil and Malaysia, and in Canada for cluster headache. U.S. approval is expected in 2015.