The Food and Drug Administration (FDA) has cleared Nerivio® for the preventive treatment of migraine with or without aura in patients 12 years of age and older. Previously, the device was only approved for acute treatment of episodic or chronic migraine.
Nerivio is a wireless remote electrical neuromodulation (REN) device designed to be self-applied to the upper arm. The prescription device uses electrical pulses to stimulate C and Aδ nociceptive sensory fibers of the upper arm to activate the brain’s conditioned pain modulation response to treat pain and migraine symptoms. Nerivio is recommended for use every other day for prevention or at the start of a migraine attack for acute treatment.
Controlled by a smartphone application, the user can adjust the stimulation intensity, monitor the duration of treatment, and pause or stop the stimulation. The app also includes a migraine diary, which can be shared between patients and health care professionals. The Company has increased the migraine treatments per unit by 50% from 12 to 18 treatments to support both existing and new users.
The clearance was supported by data from a 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. Results showed that Nerivio met the primary endpoint achieving a superior mean reduction of migraine days per month from baseline of 4.0 ± 4.0 days vs 1.3 ± 4.0 days for placebo (therapeutic difference of 2.7; P <.001); this was consistent when analyzing the episodic and chronic migraine subgroups.
Additionally, Nerivio was found to be superior to placebo for key secondary endpoints, including the reduction of moderate to severe headache days (3.8 ± 3.9 vs 2.2 ± 3.6, respectively; P =.005), reduction of headache days of all severities (4.5 ± 4.1 vs 1.8 ± 4.6; P <.001), percentage of patients achieving 50% reduction in moderate to severe headache days (51.6% [n=49/95] vs 35.7% [n=30/84]; P =.033), and reduction in days of acute medication intake (3.5 ± 4.1 vs 1.4 ± 4.3; P =.001).
“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.
The Nerivio device is contraindicated for use in patients with congestive heart failure, severe cardiac or cerebrovascular disease, uncontrolled epilepsy, or in those with an active implantable medical device (eg, pacemaker, hearing aid implant).
- Theranica’s Nerivio® cleared by FDA for preventive treatment of migraine. News release. Theranica. Accessed March 1, 2023. https://www.prnewswire.com/news-releases/theranicas-nerivio-cleared-by-fda-for-preventive-treatment-of-migraine-301757472.html.
- Tepper SJ, Rabany L, Cowan RP, et al. Remote electrical neuromodulation for migraine prevention: A double-blind, randomized, placebo-controlled clinical trial. Headache. Published online January 27, 2023. doi:10.1111/head.14469
This article originally appeared on MPR