Nerivio Prescription Wearable Cleared by FDA for Preventive Treatment of Migraine

The US Food and Drug Administration (FDA) on February 28, 2023, cleared Nerivio for preventive treatment of migraine with or without aura in persons aged ≥12 years, expanding the use of the remote electrical neuromodulation (REN) device from its original clearance in 2019 for acute treatment of episodic or chronic migraine. The announcement was made by Nerivio manufacturer, Theranica.

The Nerivio wireless REN device is self-applied by wrapping and securing it around the lateral upper arm. Using electrical pulses, the device stimulates C and Aδ nociceptive sensory fibers of the upper arm to activate conditioned pain modulation (CPM), a descending analgesic mechanism in which a subpain-threshold stimulation (eg, in the arm) inhibits pain in remote body regions (eg, the head). Nerivio is recommended for use every other day for prevention or at the start of a migraine attack for acute treatment. Each treatment lasts 45 minutes, whether for prevention or acute migraine management.

Using a smartphone application, a Nerivio user can modulate intensity of the stimulation, monitor treatment duration, and pause or stop the treatment. Users can share with health care professionals an in-app migraine diary that records and tracks headache characteristics.

In anticipation that the device's new dual-use indication may prompt current patients to increase use to proactively prevent migraines, Theranica has increased the treatments per Nerivio unit by 50% from 12 to 18 treatments, to better support both new and existing users, according to the company.

FDA's clearance for the expanded indication is based on data from a pivotal randomized, double-blind, placebo-controlled trial that compared the efficacy and safety of Nerivio to placebo used every other day for the prevention of migraine in 248 patients with episodic and chronic migraine. According to the study findings, published in the journal Headache, Nerivio met the primary endpoint, ie, change in mean number of migraine days per month from baseline, reaching a superior 4.0 ± 4.0 days vs 1.3 ± 4.0 days for placebo (therapeutic difference 2.7; P<.001). The significance was consistent when episodic and chronic migraine subgroups were analyzed.

The device was also superior to placebo across a range of prespecified secondary endpoints that included:

• Reduction of moderate to severe headache days (3.8 vs 2.2; P=.005)
• Reduction of headache days of all severities (4.5 vs 1.8; P<.001)
• Percentage of patients achieving 50% reduction in moderate to severe headache days (51.6% vs 35.7%; P=.033)
• Reduction in days of acute medication intake (3.5 vs 1.4; P=.001)

Migraine is frequently treated with acute medications that include nonprescription over-the-counter analgesics and a wide range of prescription oral, intranasal, and injectable agents. For some individuals with migraine, the treatments may be poorly tolerated, contraindicated, or ineffective. Overuse of some may lead to secondary headache diagnoses.

"The high efficacy of Nerivio compared to placebo in this well-controlled and well-executed study shows the significant potential of REN as a solid non-pharmacological option to treat and prevent migraine," says Stewart J. Tepper, MD, lead author of the study, professor of neurology, Geisel School of Medicine at Dartmouth and director, Dartmouth Headache Center at Dartmouth Health, in the Theranica statement.

"Nerivio was purposely built to meet the real-life needs of people living with migraine," says Theranica CEO and founder Alon Ironi. "While there is an established desire for effective non-drug options, especially for adolescents, migraine care needs to treat the whole person given the nature of this long-term disease. With this in mind, we developed an innovative wearable with a personalized wraparound care plan. We are hopeful this expanded dual-use indication will have a tremendous impact on mitigating the burden of migraine symptoms and improving patient quality of life."