Nerivio Neuromodulation Therapy Demonstrates Continued Efficacy, Safety At 1 Year

Andrea Synowiec, DO

Data from a US-based study (NCT05760638) of patients with migraine showed that treatment with Theranica’s Nerivio remote electrical neuromodulation (REN) device was safe and effective over a 1-year period, with low rates of adverse events (AEs) and sustained pain relief and freedom from migraine status. Overall, these data point to REN as an advantageous non-drug option for the long-term management of this chronic disease.

Published in Advances in Therapy, the analysis included 409 patients with migraine who were treated with REN for 12 consecutive months, resulting in a total of 39,531 treatments. Led by Andrea Synowiec, DO, a neurologist and headache specialist in the department of neurology at Allegheny Health Network, the study aimed to examine Nerivio’s long-term safety, efficacy, and usage in a real-world setting. The average age of the cohort was 45.8 (SD, 15.9) years, with mostly females (84.6%) included.

Each patient underwent an average of 8.05 (SD, 1.15) REN treatments over the 12-month period. At 1 year, consistent efficacy in at least 50% of all treatments per patient was achieved by 74.1% (180 of 243) of patients for pain relief, by 26.0% (67 of 258) for pain freedom, by 70.2% (177 of 252) for functional disability relief, and by 33.7% (85 of 252) for functional disability freedom. For associated symptoms, treatment response in half or more of patients’ treatments per month was achieved by 43.2% (95 of 220) of patients for photophobia, by 52.7% (107 of 203) of patients for phonophobia, by 70.8% (121 of 171) of patients for nausea/vomiting, and by 73.5% (180 of 245) of patients for at least 1 associated symptom.

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"When assessing the clinical benefits of therapies for chronic neurological disorders such as migraine, it's important to evaluate patient adherence and clinical efficacy over a long period of time, in order to eliminate possible tachyphylaxis or waning over time,” Synowiec said in a statement. "This large sample size study gives physicians and patients alike the evidence-based confidence that the impact of Remote Electrical Neuromodulation (REN) with Nerivio is sustainable over a long time. Adherence to treatment is crucial to obtaining maximal efficacy, and the persistent 12-month adherence demonstrated in this study is very encouraging."

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Nerivio has been FDA-cleared for the acute and/or preventive treatment of migraine in patients 12 years of age or older for several years now. In the study, the wearable, smartphone-controlled, non-pharmacological device, demonstrated a safe profile that was consistent with previous trials. In total, 9 AEs were reported among 409 treated patients, 8 of which were device-related. Of these, 2 were considered negligible, 5 mild, and 1 moderate. Most common device-related AEs were local paranesthesia or skin sensitivity in the stimulation area, neither of which were severe.

Despite device-related AEs, all patients continued on with their treatment. Using a repeated-measures ANOVA model, data showed that the month-to-month number of treatments conducted by patients did not differ significantly between the 12 months of consecutive treatment (F[4.9-1997.2] = 2.0; P = .075). Additionally, month-to-month efficacy values of pain relief, pain freedom, disability relief, functional disability freedom, and the disappearance of associated symptoms were not significantly different over the consecutive treatment period.

"With migraine being almost a life-long disease, patients need therapies they can rely on to help them maintain their quality of life and reduce the burden of the disease,” Alon Ironi, chief executive officer and co-founder, Theranica, said in a statement.¹ "Whether you are a high school student, a police officer, or a musician, if you live with migraine, you want a trustworthy treatment that combines persistent high efficacy, minimal side effects and ease of use. We designed Nerivio with exactly these requirements in mind."

REFERENCES
1. New study demonstrates consistent positive long-term adherence and efficacy of Nerivio for treatment of migraine. October 25, 2023. Accessed November 6, 2023. https://www.prnewswire.com/news-releases/new-study-demonstrates-consistent-positive-long-term-adherence-and-efficacy-of-nerivio-for-treatment-of-migraine-301966050.html
2. Synowiec S, Stark-Inbar A, Weinstein M, Ironi A, Mauskop A. One-year consistent safety, utilization, and efficacy assessment of remote electrical neuromodulation (REN) for migraine treatment. Advances in Ther. Published online October 19, 2023. doi:10.1007/s12325-023-02697-6