The Food and Drug Administration (FDA) has expanded the approval of Nerivio® (Theranica) to include acute treatment of episodic or chronic migraine in patients aged 12 years and older. Previously, the device was only approved for patients aged 18 years and older.
Nerivio is a wireless remote electrical neuromodulation 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. It is controlled by a smartphone application that allows the user to 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 approval was based on data from an open-label, single-arm study that evaluated the efficacy and safety of Nerivio in patients aged 12 to 17 years with migraine. Results showed that 71% and 35% of patients treated with Nerivio achieved pain relief and complete freedom from pain after 2 hours, respectively; among these patients, 90% had sustained pain relief for 24 hours. Moreover, 69% of patients experienced improvement in functional ability after 2 hours. Nerivio was well tolerated with no device-related serious adverse events.
“Teens do not always want to take pills, and some may be unable to do so due to various contraindications,” said Dr Jennifer McVige, a board-certified physician in pediatric neurology, adult and pediatric headache and neuroimaging at the DENT Neurologic Institute and an investigator in the clinical study. “Nerivio is an efficacious smartphone-controlled tech solution that can be worn inconspicuously and is the perfect design for teens who may unfortunately begin to experience migraine attacks.”
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 (ie, pacemaker, hearing aid implant).
For more information visit theranica.com.
FDA approves Theranica’s Nerivio® for acute treatment of migraine in adolescents. [press release]. Netanaya, Israel and Montclair, NJ: Theranica; January 25, 2021.