Nerivio Gets FDA Nod for Use in Migraine Prevention 2023

The convenience and ease of use of the device is part of its appeal. “Nerivio was purposely built to meet the real-life needs of people living with migraine,” Alon Ironi, Theranica’s CEO and founder, said in a press release announcing the most recent approval. Ironi’s daughter was diagnosed with migraine as a teenager, yet available pharmaceutical treatments caused her to suffer unpleasant side effects. His daughter’s experience gave Ironi personal insight into the need for non-pharmaceutical treatments for this difficult-to-treat condition.¹

FDA approval was based on a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial involving 248 participants. The results were published in Headache this January.² The trial consisted of a four-week observation phase followed by an eight-week intervention phase. In the intervention phase, participants used either the device or a sham device. They were told to use the device 45 minutes every other day for prevention and to use their normal medications for acute attacks. Those using Nerivio experienced an improvement of four fewer migraine days than baseline, while the placebo group reported a reduction of only 1.3 days. Participants also experienced statistically significant reductions in the number of days in which they required medication for acute headache. No serious adverse events were reported in either group.

The App

The smartphone app that controls the device offers users additional benefits, such as the ability to customize their treatments, receive reminders for preventive treatments, track the patterns of their headaches, and, if they choose, share this data with their physicians.