Theranica’s Nerivio(R) Cleared by FDA for Preventive Treatment of Migraine

Theranica, a prescribed digital therapeutics company developing advanced neuromodulation devices for migraine and other pain conditions, today announced that the Nerivio® prescription wearable recently received Food and Drug Administration (FDA) clearance as a dual-use acute and preventive treatment for migraine with or without aura in people 12 years of age or older. In a randomized placebo-controlled study, the drug-free Nerivio, used every other day, demonstrated significant reduction in monthly migraine days and other prevention endpoints.

Nerivio previously received clearance as an acute treatment for migraine in the same patient population, based on previous clinical studies demonstrating consistent relief of pain and associated migraine symptoms.

Research shows that for some people, prescription drugs can be poorly tolerated or ineffective. In addition, if consumed too frequently, some drugs may lead to medication overuse headache. Nerivio offers an alternative drug-free treatment.

Nerivio is a novel, physician-prescribed treatment for migraine that is discreet and non-disruptive to everyday living. Controlled with a smartphone and self-administered, Nerivio wraps around the upper arm and uses non-painful remote electrical modulation (REN) to activate peripheral nerves, inducing the internal pain management mechanism called conditioned pain modulation (CPM) in remote body regions. In simpler terms, the upper arm is stimulated to control the migraine pain in the head. Each treatment lasts 45 minutes and is recommended for use every other day for prevention or at the start of a migraine attack for acute treatment.

With Nerivio’s new dual-use indication, patients may use the wearable more frequently in an effort to proactively prevent migraines. To better support existing and new Nerivio users alike, Theranica is increasing the migraine treatments per unit by 50% from 12 to 18 treatments.

Migraine is a non-curable neurological disease that can cause chronic headache, nausea, sensory hypersensitivity, and many other symptoms, affecting more than 1 billion people worldwide and about 10 percent of children, with the prevalence rate increasing in their teenage years.

For Alon Ironi, Theranica CEO and co-founder, the expanded FDA indication for preventive treatment in adolescent patients has personal meaning. His daughter was diagnosed with migraine as a teenager; in her case, available pharmaceutical treatments led to unpleasant side effects. Ironi co-founded Theranica in 2016 to address the need for effective drug-free solutions, especially for young people.

“Nerivio was purposely built to meet the real-life needs of people living with migraine,” says 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. Nerivio is paving a bold path forward in migraine treatment and prevention for adolescents and adults. 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.”

Beyond the wearable, the Nerivio app allows users to customize their migraine treatments, receive reminders for preventive treatments, track their migraine patterns, and optionally share migraine data with their doctor. The application also leads users through a Guided Intervention of Education and Relaxation (GIER), utilizing techniques such as diaphragmatic breathing, muscle relaxation, and guided imagery.

Nerivio’s Proven Results for Preventing Migraine

The new FDA indication for Nerivio is supported by statistically significant results from Theranica’s preventive clinical trial, which was peer-reviewed and published in the journal Headache, the journal of the American Headache Society, demonstrating the efficacy and safety of Nerivio used every other day for the prevention of migraine.

The double-blind, randomized, placebo-controlled clinical trial consisted of a four-week baseline observation phase, followed by an eight-week double-blind intervention phase, in which 248 participants used either REN with Nerivio or a placebo (sham) wearable every other day. Participants who used Nerivio experienced a mean reduction of 4 migraine days per month from baseline compared to a reduction of only 1.3 days in the placebo group, a net therapeutic gain of 2.7 days per month. Participants also experienced statistically significant reductions from baseline in the mean number of headache days of all severities and in the number of days on which they required acute migraine medication.

“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 at the Geisel School of Medicine at Dartmouth and Director of the Dartmouth Headache Center at Dartmouth Health in New Hampshire, USA.

“Nerivio already has a well-established efficacy and safety profile in acute migraine treatment,” says Andrew Blumenfeld, MD, Director of the Los Angeles Headache Center and a co-author of the paper. “Effective preventive treatment is key to managing migraine, but it is often underutilized. The trial data demonstrates Nerivio can now cover the full treatment spectrum and provide access to migraine prevention and relief, especially for the adolescent population, who have a strong preference for clinically effective, drug-free treatment solutions. With FDA clearance of the device, its availability and potential use for preventive and acute treatment is welcome news for both physicians and patients.”