April 19, 2012 – ElectroCore LLC received full approval today from the US Food and Drug Administration for its pilot study of the GammaCore® therapy in patients suffering from acute migraine headache. This 30-patient multi-center randomized pilot study to investigate the feasibility and safety of utilizing the GammaCore therapy on patients for relief of acute migraine headache pain enrolled its first subject (under Conditional Approval) on February 23, 2012. The study is listed on www.ClinicalTrials.gov.
ElectroCore is a healthcare company focused on novel therapies for treating diseases and disorders and technologies for delivering these therapies. Based in Morris Plains, NJ, the Company is currently in the IDE phase in the United States, and early commercial phase within the EU and other key countries with its first two CE marked therapies.
GammaCore therapy is a proprietary neuromodulation treatment that modulates how the brain perceives and generates pain. The GammaCore device is intended for non-invasive stimulation of the vagus nerve in the neck.
GammaCore is CE marked and indicated for the acute and/or prophylactic treatment of Migraine, Cluster, Hemicrania Continua (HC) and Medication Overuse Headache (MOH) in adults.