FDA Approves Wearable Device for Migraine Prevention
/By Pat Anson, PNN Editor
A wearable neuromodulation device has been approved by the Food and Drug Administration as a preventative treatment for migraine. In a recent study, the Nerivio device significantly reduced the number of migraine days per month in patients with episodic and chronic migraine.
Nerivio is worn on the upper arm and controlled by a smartphone app. It uses mild electrical pulses to disrupt pain signals in the brain without the use of drugs. The device has previously received clearance from the FDA as an acute treatment for migraine in adults and children over age 12.
"Nerivio already has a well-established efficacy and safety profile in acute migraine treatment," said Andrew Blumenfeld, MD, Director of the Los Angeles Headache Center and co-author of the study published in the journal Headache. "Effective preventive treatment is key to managing migraine, but it is often underutilized.”
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The randomized, placebo-controlled trial involved 248 migraine sufferers who used either Nerivio or a placebo device for 45 minutes every other day. Those who used Nerivio experienced a mean reduction of 4 migraine days per month, compared to a reduction of 1.3 days in the placebo group. Participants also experienced statistically significant reductions in the number of days they required acute migraine medication.
“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," Blumenfeld said in a statement.
Like most new migraine treatments, Nerivio can be expensive, with the wholesale price currently listed at $599 for a 12-treatment unit. Out of pocket costs will be less if the device is covered by insurance or if patients enroll in Nerivio’s Patient Savings Program. A prescription is required.
With Nerivio’s new dual-use indication, patients may use the device more often to proactively prevent migraines. To better support existing and new users, the number of treatments per unit is being expanded from 12 to 18 treatments.
The Nerivio app allows patients to customize their treatment, receive reminders for preventive treatment, track their migraine patterns, and share migraine data with their doctor. The app can also leads users through a Guided Intervention of Education and Relaxation, using techniques such as diaphragmatic breathing, muscle relaxation and guided imagery.
Nerivio is made by Theranica, a medical technology company based in Israel, which estimates the device has over 40,000 users in the United States. The company is investigating whether the device may help treat other chronic pain conditions besides migraine.
