Device profile of the Nerivio™ for acute migraine treatment: overview of its efficacy and safety

ABSTRACT

Introduction: Noninvasive neuromodulation devices represent an emerging field in the acute treatment of migraine. High efficacy, favorable safety profile, good tolerability and low cost are important factors for the desired shift to non-pharmacological treatments. This will have the potential to improve the quality of life of people with migraine and reduce the risk for adverse events and medication overuse headache (MOH).

Areas covered: Nerivio™ (Theranica Bio-Electronics, Israel) is a novel FDA-cleared remote electrical neuromodulation (REN) device for acute treatment of migraine. This review highlights the mechanism of action of REN and summarizes the clinical data. Nerivio™ has been studied in two randomized trials which provide support for the efficacy and safety of the device. Post-hoc analyses suggest that the efficacy of REN is non-inferior to usual care in general and to acute pharmacological treatments specifically.

Expert commentary: Nerivo™ integrates clinically meaningful efficacy with a high safety profile, satisfying a great unmet need in migraine acute care. The unique mechanism of action, in which the electrical stimulation is applied to peripheral nerves in the upper arm, permits the introduction of an innovative device with high efficacy and superior and improved usability aspects compared with acute pharmacological treatments and other approved devices.

KEYWORDS:

• Acute treatment
• conditioned pain modulation
• headache
• migraine
• migraine treatment
• Nerivio
• remote electrical neuromodulation

Article highlights

• Nerivio™ is a novel, FDA-cleared non-pharmacological, non-invasive neuromodulation device for the acute treatment of migraine

• The device is applied to the upper arm at the onset of a migraine headache or aura to induce conditioned pain modulation (CPM), a descending endogenous analgesic mechanism

• The efficacy of Nerivio is notable, with a therapeutic gain of 27.9% for pain relief and 19% for pain freedom, both at 2 hours

• Nerivio™ has good 2 hour and 48 hour data

• Nerivio™ is safe and well-tolerated

Declaration of interest

A Rapoport serves as an advisor for Allergan, Amgen, Amneal, Assertio, Autonomic Technologies, Biohaven, Neurolief, Promius, Satsuma, Teva Pharmaceutical Industries, Theranica, Xoc, Cala Health, and Zosano; and he is on the speakers’ bureau of Amgen and Teva. T Lin is an employee of Theranica Bio-Electronics Ltd. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

One peer reviewer has done consulting for Amgen, Alder, Allergan, Alpha Sites Consulting, Biohaven, Electrocore, Eli-Lilly and Company, Promius, Impel, Satsuma, Supernus, Teva, Revance, Zosano, & Theranica; is on the speakers’ bureaus of Allergan, Amgen, Eli-Lilly and Company, & Teva; has done content development/delivery (CME/Non-CME) for Aptus, Peer View, Medscape, Miller Medical, Medical Education International, & Neurology Live; done clinical trials for ARMR Registry (American Migraine Foundation), Biohaven, Allergan, Eli-lilly and company, and is an editor for Current Pain and Headache. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded by external sources.