US-based healthcare company ElectroCore has received regulatory approvals for its non-invasive vagus nerve stimulation therapy from the Therapeutic Goods Administration in Australia and the National Institute of Surveillance of Medicine and Foods in the Ministry of Health in Colombia.
The non-pharmaceutical GammaCore neuromodulation therapy, which transmits a mild electrical signal to the vagus nerve through the skin, is indicated for the acute and / or prophylactic treatment of primary headache (migraine, cluster headache and Hemicrania Continua) and medication overuse headache in adults.
ElectroCore CEO JP 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 said.
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 trial, which will study the acute benefits of treatment of cluster headache events in 150 subjects at fifteen sites across the US, is expected to begin enrolment during the first quarter of 2013.
The company said it will use the pivotal study results to file a pre-market approval (PMA) application with the FDA to use GammaCore for the acute treatment of cluster headaches.
In addition, the company began patient enrolment at seven sites across the US for its FDA-approved randomised, sham-controlled chronic migraine prevention study using GammaCore.
The study will include 60 patients with migraine for more than fifteen days per month, and expects to provide an initial read-out during the first half of 2013, according to the company.
The company’s other current commercial products include AlphaCore and GammaCore VET.