On May 28, the U.S. Food and Drug Administration (FDA) authorized Theranica, an Israeli biomedical technology company, to market Nerivio Migra®, an electronic device controlled by smartphone for the acute treatment of migraine.
Nerivio Migra® is a product that sits on top of the arm and uses smartphone-controlled electronic impulses to create a conditioned pain modulation (CPM) response. Nerivio Migra® is indicated for the acute treatment of migraine with or without aura in adult patients who do not have chronic migraine.
The market authorisation is supported by data from a prospective, randomised, double-blind study that evaluated the efficacy, safety and tolerability of wearable technology in 252 patients who met the criteria of the International Classification of Headache Disorders, Third Edition (ICHD-3) for migraine with or without aura. Data from this study were presented at the 2018 annual symposium of the American Headache Society.
In the study, patients were randomized 1:1 to the active arm (Nerivio Migra) or placebo. The primary pain relief endpoint at 2 hours after treatment showed a response rate of 66.7% 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 painless at 2 hours after treatment (37.4% active versus 18.4% placebo, P <.004), the relief of the most troublesome symptom from phonophobia, photophobia and nausea at 2 hours after treatment (46.3% versus 22.2%, P <.001), and the relief of pain and the most troublesome symptom at 2 hours after treatment (40% versus 15.2%, P <.0005).
“What fascinates and excites me as a headache specialist about the study is that the results are comparable, if not superior in some respects, to the acute drugs currently available such as triptans. The results of the study satisfied both their primary endpoints, which were a percentage of people getting pain relief at 2 hours, and their secondary endpoints with freedom of pain at 2 hours and relief from most of the annoying migraine symptoms such as nausea, light sensitivity and sound sensitivity” explained Dr. Brian Grosberg, director of the Hartford Healthcare Headache Centre in Connecticut, which was the main investigator (PI) of the study.
Theranica’s product is therefore intended to be an alternative, in some cases of migraine, to treatment with drugs. The smartphone, connected to a wearable device, can bring relief to people with migraines.