Theranica said today that it won FDA de novo clearance for its Nerivio Migra remote electrical neuromodulation system intended for the acute treatment of migraines.
The approval came based off a prospective, randomized, double-blind, placebo-controlled, multi-center pivotal study of 252 patients, the Israel-based company said. Data from the study was published in Headache: The Journal of Head and Face Pain.
“This study followed the latest edition of the guidelines from the International Headache Society for controlled trials of acute treatment of migraine attacks in adults. The results of the study demonstrate a high efficacy ratio for single as well as multiple attacks, both at two and 48 hours after treatment,” study co-author and lead principal investigator Dr. Brian Grosberg of the Conn.-based Hartford Healthcare Headache Center said in a prepared statement.
“The clinical data of this innovative therapeutic device is of very high quality. It indicates that the device can provide patients with significant relief of pain and other migraine symptoms without the side effects presented by drugs,” Dr. Messoud Ashina of the Danish Headache Center and the International Headache Society said in a press release.
The Nerivio Migra is designed to be placed on the upper arm and uses smartphone-controlled electronic pulses to create a conditioned pain modulation response, Theranica said.
The device is currently indicated for the acute treatment of migraines with or without aura in adult patients who do not have chronic migraines, the company said.
“Physicians who treat people with migraine are both patient-centered and science-driven. Over the last 20 years my colleagues and I have used triptans and ergots for acute migraine treatment. There is a large unmet need for new treatments in this population when these medications are not effective, are contra-indicated, or have non-tolerable side effects. In addition, triptans and most current acute migraine medications, including over-the-counter drugs indicated for migraine, are associated with medication-overuse headache, which is associated with increased frequency of migraine attacks, and often results in chronic migraine. This new innovative FDA-authorized treatment is an important alternative to help our patients control this debilitating condition,” Theranica medical advisory board member Dr. Stephen Silbersteinsaid in prepared remarks.
“While the company is preparing to launch the Nerivio Migra in the United States market later this year at an affordable price, we remain committed to continuing our clinical development, expanding the use of remote electrical neuromodulation therapy for additional indications. We have identified at least seven different painful conditions that may be relieved by this non-invasive, drug-free technology after appropriate clinical development,” co-founder & CEO Alon Ironi said in a prepared statement.