Therapeutic Goods Administration in Australia and the National Institute of Surveillance of Medicine and Foods in the Ministry of Health in Colombia have approved ElectroCore's non-invasive, non-pharmaceutical vagus nerve stimulation therapy.
GammaCore neuromodulation therapy, which transmits mild electrical signal to the vagus nerve through the skin, is designed for the acute and/or prophylactic treatment of primary headache (migraine, cluster headache and Hemicrania Continua) and medication overuse headache in adults.
ElectroCore CEO J.P. Errico said the approval confirms that the GammaCore therapy is safe and effective for use.
"These approvals are great news for patients in Australia and Colombia who suffer from primary headache, as they provide another non-invasive treatment option," Errico added.
Currently available in Australia, the vagus nerve stimulator is expected to be available in Colombia in the first half of 2013.
ElectroCore has also received approval from the US Food and Drug Administration (FDA) to commence a pivotal study of GammaCore as an acute treatment for cluster headaches.
The company’s other commercial products on the market include AlphaCore and GammaCore VET.