After its recent FDA clearance, the smartphone-controlled Nerivio Migra makes its entrance into the market in the fall. Theranica’s CEO and co-founder spoke to its clinical efficacy and advantages for patients and physicians.
“The mechanism of action is actually quite unique, it’s called conditioned pain modulation. The device is actually triggering an endogenous mechanism in the brain stem which initiates a descending mechanism pathway. The result is the release of certain pain-inhibiting neurotransmitters, globally, and so the impact is quite rapid and strong.”
In May, the FDA 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.1
To find out more about the device’s commercial roll out in the United States this fall and about the advantages it offers patients and physicians, NeurologyLive® spoke with Alon Ironi, CEO and co-founder, Theranica, on-site at the 2019 American Headache Society (AHS) Annual Meeting, July 11-14, 2019, in Philadelphia, Pennsylvania.
During its development, it was assessed in TCH-003, a prospective, randomized, double-blind, sham-controlled, and multi-center study of 252 patients who met the International Classification of Headache Disorders, Third Edition (ICHD-3) criteria for migraine with or without aura. They were randomized 1:1 to either the Nerivio Migra non-invasive neuromodulation device or placebo.
Led by Brian Grosberg, MD, director, Hartford Healthcare Headache Center, the primary end point of pain relief at 2 hours post-treatment with the device demonstrated a 66.7% response rate in the active arm compared to 38.8% in the placebo arm (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).2
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1. FDA Grants Theranica De Novo to Market First Smartphone-controlled Acute Migraine-relief Wearable Device [press release]. Netanya, Israel: Theranica; May 28, 2019. prnewswire.com/news-releases/fda-grants-theranica-de-novo-to-market-first-smartphone-controlled--acute-migraine-relief-wearable-device-300857281.html. Accessed July 31, 2019.
2. 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 July 31, 2019.