FDA granted market authorization for a non-invasive, smartphone device that offers respite from migraines.
FDA granted market authorization for a novel smartphone-controlled device to treat acute migraines.
Placed on the upper arm, Nerivio Migra (Theranica) uses smartphone-controlled electrical pulses to create a Conditioned Pain Modulation (CPM) response. The first-in-category device uses Remote Electrical Neuromodulation, Theranica said in a statement.
The company plans to launch the device in the US market later this year “at an affordable price,” said Alon Ironi, CEO and co-founder of Theranica.
"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, said Professor Messoud Ashina, MD, president-elect of the International Headache Society, in the Theranica statement.
FDA market authorization is based on the results of a prospective, randomized, double-blind, placebo-controlled, multicenter pivotal study. In the study, 252 patients from 12 clinics used the non-invasive wearable to treat their migraine attacks.
"The results of the study demonstrate a high efficacy ratio for single as well as multiple attacks, both at 2 and 48 hours after treatment," said Brian Grosberg, MD, lead investigator of the study and director of the Hartford Healthcare Headache Center in Connecticut, in the Theranica statement.
Theranica has identified “at least 7 different painful conditions that may be relieved by this non-invasive, drug-free technology after appropriate clinical development,” Ironi said.
Migraine is the third most common disease in the world, with an estimated global prevalence of 14.7% of the world's population, according to Theranica. Migraines contribute $17 billion in annual US healthcare costs.
FDA approved the drug through the De Novo process, which provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device, the agency said on its web site.