Officials from ElectroCore, a company dedicated to developing effective, non-invasive Vagal Nerve Stimulation (nVNS) therapies for serious medical conditions including primary headaches, announce that its GammaCore therapy has been approved for commercial sale by the Therapeutic Goods Administration in Australia and the National Institute of Surveillance of Medicine and Foods in the Ministry of Health in Colombia. GammaCore's non-invasive, non-pharmaceutical, neuromodulation therapy is indicated for the acute and/or prophylactic treatment of primary headache (migraine, cluster headache, and Hemicrania Continua) and medication overuse headache in adults.
GammaCore is currently available to patients in Australia who are under the care of a physician and can be ordered through ElectroCore Australia. ElectroCore plans to make the device available in Colombia in the first half of 2013.
"These approvals represent significant additional regulatory validation of the GammaCore technology as a safe and effective therapy," states J.P. Errico, CEO of ElectroCore. "These approvals are great news for patients in Australia and Colombia who suffer from primary headache, as they provide another non-invasive treatment option."
ElectroCore recently received U.S. Food and Drug Administration (FDA) approval to begin its pivotal study of GammaCore as an acute treatment for cluster headaches. This trial, expected to begin enrolling during the first quarter of 2013, will study the acute benefits of treatment of cluster headache events in 150 subjects at fifteen sites across the U.S. Based on the results of the study, ElectroCore plans to submit a Pre-Market Approval (PMA) for FDA approval of GammaCore for the acute treatment of cluster headaches. GammaCore is not currently available for sale in the U.S.
In January, company officials announced that initial enrollment has begun for its FDA-approved chronic migraine prevention study using GammaCore. The randomized, sham-controlled study is enrolling patients at seven sites across the U.S. The study, which is expected to offer an initial read out during the first half of this year, will include 60 patients who suffer with migraine more than fifteen days per month.
GammaCore is a non-invasive, vagus nerve stimulator that produces a mild electrical signal, which is transmitted to the vagus nerve through the skin. GammaCore is currently available in the European Union, Canada, South Africa, India, New Zealand, and Malaysia. In Canada, GammaCore is indicated to treat cluster headache only.