The Food and Drug Administration (FDA) has cleared Nerivio Migra (Theranica), a prescription smartphone-controlled device for the acute treatment of migraine with or without aura in adults who do not have chronic migraine.
The device uses electrical pulses, which are controlled by the users smartphone, to create a Conditioned Pain Modulation (CPM) response. While other pulse devices for migraine are worn on the head or neck, the Nerivio Migra is designed for the upper arm.
The FDA’s approval was based on data from a placebo-controlled study (N=252) in which the efficacy and safety of the remote electrical neuromodulation device was evaluated for the acute treatment of migraine. The device was applied for 30-45 minutes within an hour of migraine attack onset; pain levels were assessed at baseline, 2 hours, and 48 hours after treatment.
Results showed that 66.7% (66/99) of patients in the treatment group achieved pain relief at 2 hours post-treatment (primary endpoint) vs 38.8% (40/103) in the placebo group. “The results of the study demonstrate a high efficacy ratio for single as well as multiple attacks, both at 2 and 48 hours after treatment,” said lead principal investigator Brian Grosberg, MD, director of the Hartford Healthcare Headache Center in Connecticut.
According to Theranica, additional real-world studies will be conducted in the next 4 months in order to assess proper patient selection, correct product use in the home, and adherence to physician direction. Once completed, the Company will notify physicians of the availability of Nerivio Migra.
For more information visit theranica.com.