FDA granted Theranica's De Novo request for its smartphone-controlled electroceutical, Nerivio Migra, using remote electrical neuromodulation for the acute treatment of migraine.Theranica
FDA granted marketing authorization of Theranica's Nerivio Migra through the De Novo pathway. The device is worn on the patient's arm and uses smartphone-controlled electronic pulses to create a conditioned pain modulation (CPM) response.
The Nerivio Migra was one of a handful of device-based migraine treatments MD+DI featured earlier this year. The device is indicated for acute treatment of migraine with or without aura in adult patients who do not have chronic migraine. One device included on that list is electroCore's gammaCore vagus nerve stimulator, which FDA cleared last year for the prevention of cluster headache.
In November 2018 Theranica reported results of a prospective, randomized, double-blind, sham-controlled, multi-center study that evaluated the efficacy, safety, and tolerability of the device on 252 patients diagnosed with migraine with or without aura. The study met its primary endpoint and almost all of its secondary and exploratory results with high statistical significance. On its primary endpoint of pain relief at 2 hours post-treatment, the device demonstrated a 66.7% response rate in the active arm vs. 38.8% in the placebo group (p<0.0001). On the secondary endpoint of being pain-free at 2 hours post-treatment, the response rate was 37.4% (active) vs. 18.4% (placebo) (p<0.004).
On the secondary endpoint of relief of the most bothersome symptom (MBS) out of phonophobia, photophobia, and nausea at 2 hours post-treatment, the response rate was 46.3% (active) vs. 22.2% (placebo) (p<0.001). On the secondary endpoint of relief of both pain and the MBS at 2 hours post-treatment, the response rate was 40.0% (active) vs. 15.2% (placebo) (p<0.0005).
“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,” said Brian Grosberg, MD, director of the Hartford Healthcare Headache Center in Connecticut, who served as the lead principal investigator of the study. “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."
Alon Ironi, CEO and co-founder of Theranica, said the company plans to launch the Nerivio Migra in the United States later this year. He also noted that the company is pursuing potential future indications for the device.
“We have identified at least seven different painful conditions that may be relieved by this non-invasive, drug-free technology after appropriate clinical development," Ironi said.
“Physicians who treat people with migraine are both patient-centered and science-driven,” said Stephen Silberstein, director of the Headache Center at the Jefferson University Hospital in Philadelphia, and a member of Theranica's medical advisory board. “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."
Silberstein also noted that 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.