Theranica has announced that its drug-free Nerivio prescription wearable recently received US 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 randomised, placebo-controlled study, Nerivio—used every other day—has demonstrated significant reductions 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, according to Theranica.
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—a novel, physician-prescribed treatment for migraine that is intended to be discreet and non-disruptive to everyday living—offers an alternative drug-free treatment in this space.
Controlled with a smartphone and self-administered, the device wraps around the upper arm and uses non-painful remote electrical neuromodulation (REN) to activate peripheral nerves, inducing the internal pain management mechanism called conditioned pain modulation (CPM) in remote body regions. 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, the release details. To better support existing and new Nerivio users alike, Theranica is also increasing the migraine treatments per unit by 50% from 12 to 18 treatments.
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, demonstrating the efficacy and safety of the device when used every other day for the prevention of migraine.
The double-blind, randomised, 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 four migraine days per month from baseline compared to a reduction of only 1.3 days in the placebo group, constituting 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,” said lead author Stewart Tepper (Geisel School of Medicine at Dartmouth, Hanover, USA).
Beyond the wearable, the Nerivio app allows users to customise 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), utilising techniques like diaphragmatic breathing, muscle relaxation and guided imagery.