Theranica, an Israeli prescription digital therapeutics developer for migraine and other pain conditions, has received 510(k) clearance from the U.S. Food and Drug Administration for its Nerivio device.
The device has been cleared for acute treatment of episodic or chronic migraine in people 12 years and older.
Nerivio is a wireless, noninvasive remote electrical-stimulation wearable that is worn on the upper arm at the onset of a migraine. Each treatment session is 45 minutes long and uses remote electrical neuromodulation to activate the brain's native conditioned pain modulation mechanism to treat pain and associated migraine symptoms.
Users control the device with an accompanying app that can adjust the stimulation intensity, monitor the treatment duration and pause or stop treatment if needed. Within the app, users can track their migraines using a diary feature that records treatment sessions, pain levels and related symptoms. From there, users can share their migraine diary with their care teams.
WHY THIS MATTERS
The FDA clearance expands Nerivio’s indication for migraine treatment in adolescents, a condition that affects about 10% of school-age children and up to 28% of people between 15 and19, according to the Migraine Research Foundation.
In a clinical trial, 71% of the adolescent participants using Nerivio experienced pain relief after two hours, while 35% experienced complete freedom from pain, according to a study in Headache. The results were sustained for 24 hours in 90% of the participants.
The device creates a drug-free option for teens, which could improve compliance in this group, according to Dr. Jennifer McVige, a board-certified physician at the DENT Neurologic Institute, who was one of the investigators in the clinical study.
"Teens do not always want to take pills, and some may be unable to do so due to various contraindications,” she said in a statement. “Additionally, teens tend to easily adapt to tech. 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 LARGER TREND
In 2019, Theranica received De Novo clearance for the use of Nerivio among adult users who do not have chronic migraine.
Perfood, a German digital therapeutics startup, received €5 million in a Series A funding round late last year to launch its first prescription therapeutic, sinCephalea, for the treatment of migraine. Its product uses nutrition to stabilize users’ blood-sugar levels, which have been found to play a role in the development of diseases such as migraine, diabetes, heart attack, stroke and cancer.
The women’s health platform Nurx also joined the migraine treatment space recently with a new service that lets patients virtually connect with a provider and develop an individualized migraine management plan. Patients pay a $60 annual fee, which includes online medical consultations, a video exam where patients complete cognitive tests, a personalized treatment plan and tracker, check-ins with a provider, and home delivery of medication.
ON THE RECORD
"This new indication is a dramatic step in our committed effort to serve the migraine community as a whole," said Alon Ironi, Theranica's CEO and cofounder, in a statement.
"Throughout 2020, we continued pursuing clinical data regarding how Nerivio can help this all-too-large patient population. As a result, Nerivio is now widely available as a drug-free alternative to treat migraine. Teens are one of the most vulnerable migraine populations and we are happy to provide them with a user-friendly tool to get them back to their daily lives as quickly as possible."