FDA Approves Theranica's Nerivio for Preventive Treatment of Migraine

Stewart J. Tepper, MD

Theranica’s Nerivio, a remote electrical neuromodulation (REN) device, recently received FDA approval as a dual-use acute and preventive treatment for migraine with or without aura in patients 12 years of age or older.¹ The FDA indication is supported results from a randomized placebo-controlled study published in Headache which demonstrated significant reduction in monthly migraine days and other prevention end points.

Patients who used Nerivio had a mean reduction of 4 migraine days per month from baseline compared to a reduction of only 1.3 days in the placebo group, a net therapeutic gain of 2.7 days per month. In addition, participants also showed statistically significant reductions from baseline in mean number of headache days of all severities and in 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 nonpharmacological option to treat and prevent migraine," 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, said in a statement.¹

The trial consisted of a 4-week baseline observation phase, followed by an 8-week double-blind intervention phase, in which 248 participants used either REN with Nerivio or a placebo wearable every other day.

"Nerivio was purposely built to meet the real-life needs of people living with migraine," said Alon Ironi, Theranica CEO and co-founder Ironi, in a statement.¹ "While there is an established desire for effective non-drug options, especially for adolescents, migraine care needs to treat the whole person given the nature of this long-term disease. With this in mind, we developed an innovative wearable with a personalized wraparound care plan. Nerivio is paving a bold path forward in migraine treatment and prevention for adolescents and adults. We are hopeful this expanded dual-use indication will have a tremendous impact on mitigating the burden of migraine symptoms and improving patient quality of life."

Previously, in January 2021, Nerivio received clearance as an acute treatment for migraine in the same patient population, based on a single-arm, multicenter study. That study included 45 participants with episodic and chronic migraine who completed a test treatment with the REN and found there to be only 1 device-related adverse event (AE; 2%) which was a temporary feeling of pain in the arm.² The results showed that pain relief and pain freedom at 2 hours were achieved by 71% (28 of 39 participants) and 35% (14 of 39) of participants, respectively.

"Nerivio already has a well-established efficacy and safety profile in acute migraine treatment," says Andrew Blumenfeld, MD, director of the Los Angeles Headache Center and a co-author of the paper said in a statement.¹ "Effective preventive treatment is key to managing migraine, but it is often underutilized. 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."

Nerivio is the first FDA-cleared smartphone-controlled prescription wearable device for acute migraine treatment of episodic or chronic migraine in people 12 years and older and received another prior approval in October 2020. At the time, it was only approved for patients aged 18 years and older.³ Its initial de novo clearance was granted in May 2019, for the acute treatment of migraine with or without aura in adults.⁴

Each Nerivio device is good to use for 12 treatments, after which a newly dispensed device can be given to fill prescriptions. The device can be recycled upon the need to discard it. The prescription device is self-applied to the upper-arm and is used in the home environment at the onset of migraine headache or aura. It gained national recognition in November 2019 after it was named to TIME Magazine’s annual list of top 100 best inventions. Nerivio is also available by prescription by any licensed healthcare provider and can be accessed on telemedicine platforms such as Cove and UpScript.

REFERENCES
1. Theranica's Nerivio Cleared by FDA for Preventive Treatment of Migraine. Theranica. News Release. Published February 28, 2023. Accessed February 28, 2023. https://www.prnewswire.com/news-releases/theranicas-nerivio-cleared-by-fda-for-preventive-treatment-of-migraine-301757472.html
2. FDA approves Theranica’s Nerivio for acute treatment of migraine in adolescents. News release. January 25, 2021. Accessed February 28, 2023. https://www.prnewswire.com/news-releases/fda-approves-theranicas-nerivio-for-acute-treatment-of-migraine-in-adolescents-301213967.html
3. Nerivio receives clearance of expanded indication to cover chronic migraine patients. News release. Theranica Biotherapeutics. October 26, 2020. Accessed February 28, 2023. prnewswire.com/news-releases/nerivio-receives-clearance-of-expanded-indication-to-cover-chronic-migraine-patients-301159445.html
4. FDA Grants Theranica De Novo to Market First Smartphone-controlled Acute Migraine-relief Wearable Device. News release. Theranica. May 28, 2019. Accessed February 28, 2023. www.prnewswire.com/news-releases/fda-grants-theranica-de-novo-to-market-first-smartphone-controlled--acute-migraine-relief-wearable-device-300857281.html