NeuroSigma announced that it has received approval from the Therapeutic Goods Administration (TGA) to market its Monarch eTNS (external trigeminal nerve stimulation) system in Australia. The approval allows NeuroSigma to market the Monarch eTNS system for the adjunctive treatment of drug-resistant epilepsy in patients nine years of age and older.
The Monarch external trigeminal nerve stimulation system is a non-invasive adjunctive therapy for drug-resistant epilepsy that delivers low-intensity electrical current through a single-use adhesive patch to stimulate branches of the trigeminal nerve near the surface of the forehead. Patients may conveniently self-administer the therapy at home and typically use the device while sleeping. The Monarch eTNS system will be sold by prescription to patients in Australia under a physician’s supervision.
TGA approval was supported by data generated in Phase I and Phase II clinical trials in the United States measuring safety and efficacy. Results from a Phase II randomised controlled trial of eTNS for epilepsy were published in the February 26, 2013 issue of Neurology, the medical journal of the American Academy of Neurology.
Mark Cook, chair of Medicine, St Vincent’s Hospital in Melbourne, Australia noted, “I am pleased that eTNS is now available to be prescribed for the treatment of drug-resistant epilepsy in Australia. I have been following with interest the experiences that my colleagues in Europe and Canada have had with their patients and look forward to prescribing eTNS to my patients.”
In the United States, eTNS is an investigational device and is limited by Federal law to investigational use. The US Food and Drug Administration (FDA) has given NeuroSigma approval to proceed with a pivotal Phase III clinical trial of eTNS in drug-resistant epilepsy. Completion of that Phase III study is necessary before the FDA will consider permitting the marketing and sale of eTNS in the United States.