New Study Demonstrates Consistent Positive Long-Term Adherence and Efficacy of Nerivio® for Treatment of Migraine
Advances in Therapy Publishes Study Finding 12-Month Consistency in Utilization and Efficacy of Non-Drug, Non-Disruptive Wearable to Mitigate Migraine Burden
NETANYA, Israel and BRIDGEWATER, N.J., Oct. 25, 2023 /PRNewswire/ — Theranica, a neuromodulation therapeutics company, announced the publication of a comprehensive clinical study in Advances in Therapy examining the long-term utilization, clinical efficacy, and safety of Nerivio®, a Remote Electrical Neuromodulation (REN) device for the treatment of migraine.
The study included 409 participants across the entire USA who used Nerivio device for acute treatment of migraine for 12 consecutive months, reporting their data prospectively. The results showed consistent and persistent efficacy in pain relief, pain freedom, functional disability relief, and functional disability freedom, as well as consistent adherence.
Dr. Andrea Synowiec, a neurologist and headache specialist who serves as System Vice Chair of the Department of Neurology at Allegheny Health Network in Pennsylvania is the lead author of the study. She emphasized the significance of these findings stating, “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. 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”.
During the study period, users performed a total of 39,531 treatments, with a monthly average of 8.05 treatments per patient, and a standard deviation (SD) of 1.15, meaning that the month-to-month number of treatments per patients did not differ significantly along the 12 consecutive months. The non-disruptive nature of using Nerivio is designed to promote high adherence: the device can be worn under a shirt or jacket sleeve, and is self-controlled through a user-friendly smartphone app, making it ideal for discreet usage even in places that are not private, like a school class, a work office, or on a bus or a train.
Notably, the rate of device-related adverse events was extremely low – less than 2%.
As for clinical efficacy, 74.1% of the participants reported consistent 2-hour pain relief, and 26% reported consistent pain freedom.
“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,” said Alon Ironi, CEO and co-founder of Theranica. “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.”
“Theranica is committed to addressing migraine, with special emphasis on patient groups who typically have fewer therapy options, such as adolescents, veterans and active-duty service personnel, and pregnant women”, added Ironi.
Controlled by a smartphone app and self-administered, Nerivio wraps around the upper arm and uses sub-painful Remote Electrical Neuromodulation (REN) to activate nociceptive nerve fibers in the arm to send signals which trigger a descending pain management mechanism in the brain called conditioned pain modulation (CPM), which turns off migraine pain and associated symptoms without medication. In simpler terms, the upper arm is stimulated to unleash a natural process in the brain to abort or relieve migraine headaches and other associated symptoms. Each treatment lasts 45 minutes and is applied every other day for prevention or at the start of a migraine attack for acute treatment.