This device, which is being prepared to launch in the US market later this year, is an alternative treatment option for acute migraine.
Brian Grosberg, MD
The FDA has granted De Novo clearance to Theranica’s Nerivio Migra, a smartphone-controlled electroceutical device that uses non-invasive neuromodulation for the acute treatment of migraine with or without aura in adults who do not have chronic migraine.
The market authorization is backed by data from the TCH-003 prospective, randomized, double-blind, sham-controlled pivotal study that assessed the efficacy, safety, and tolerability of the wearable technology in 252 patients who met the International Classification of Headache Disorders, Third Edition (ICHD-3) criteria for migraine with or without aura. Data from this study were presented at the 2018 annual headache symposium of the American Headache Society.
“A device like this offers an opportunity for patients to not have to think about [sacrificing medication use], where they can end up using it, and they don’t have to feel like they’re necessarily sacrificing efficacy,” Brian Grosberg, MD, the director of the Hartford Headache Center in Connecticut, who was the principal investigator on the TCH-003 trial, told NeurologyLive in an interview.
In the study, patients were randomized 1:1 to either the active arm (Nerivio Migra) or placebo. The primary endpoint of pain relief at 2 hours post-treatment demonstrated a 66.7% response rate in the Nerivio Migra group versus 38.8% in the placebo group (P <.0001).
Of the 4 secondary and exploratory outcome measures, 3 were statistically significant and included the percentage of those pain-free at 2 hours post-treatment (37.4% active versus 18.4% placebo, P <.004), the relief of the most bothersome symptom out of phonophobia, photophobia, and nausea at 2 hours post-treatment (46.3% versus 22.2%, P <.001), and relief of both pain and most bothersome symptom at 2 hours post-treatment (40% versus 15.2%, P <.0005).1
“What is very fascinating and exciting to me as a headache specialist, about the study, is the results are comparable, if not superior, in some aspects, to currently available acute medications like triptans. The results of the study met both their primary endpoints which were achieiving proportion of people achieving pain relief at 2 hours, as well as their secondary endpoints with pain freedom at 2 hours and relief of most bothersome migraine symptoms like nausea, light sensitivity, and sound sensitivity,” Grosberg explained while speaking with NeurologyLive.
The device, a first-in-category product, is placed on the upper arm and utilizes smartphone-controlled electronic pulses to create a conditioned pain modulation response. The company is preparing to launch the device in the US market later this year.
1. Theranica Announces Results from Pivotal Study of Device for Treating Acute Migraine [press release]. Scottsdale, Arizona: Theranica Bio-Electronics; November 15, 2018. prnewswire.com/news-releases/theranica-announces-results-from-pivotal-study-of-device-for-treating-acute-migraine-832012898.html. Accessed May 28, 2019.
2. FDA Grants Theranica De Novo to Market First Smartphone-controlled Acute Migraine-relief Wearable Device [press release]. Netanya, Israel: Theranica; May 28, 2019. www.prnewswire.com/news-releases/fda-grants-theranica-de-novo-to-market-first-smartphone-controlled--acute-migraine-relief-wearable-device-300857281.html. Accessed May 28, 2019.