Theranica Bioelectronics Ltd. has snagged an expanded clearance from the U.S. FDA for use of its smartphone-controlled Nerivio device to treat migraines in adolescents. The new indication, for acute treatment of episodic or chronic migraine in people 12 years and older, is supported by a study published last month in the journal Headache.

An estimated 1 in 10 school-age children and up to 18% of teens ages 15 to 19 suffer from migraine – or about 5 million children between 12 and 18 in the U.S. However, most prescribed therapies for acute treatment of migraine – calcitonin gene-related peptide (CGRP) receptor antagonists and gepants – are not indicated for that age group.

Netanya, Israel-based Theranica first won FDA approval for its Nerivio Migra via the de novo pathway in 2019, for the acute treatment of migraine pain in adults without or without aura ho do not have chronic migraine. The prescription-only device, which is worn on the upper arm, uses remote electrical neuromodulation to deliver gentle electrical pulses on the skin, which help to control migraine pain.

In October, the FDA granted expanded clearance for Nerivio to include chronic migraine. The device also gained CE marking last fall.

Alon Ironi, co-founder and CEO of Theranica

“This new indication is a dramatic step in our committed effort to serve the migraine community as a whole,” said Alon Ironi, Theranica’s co-founder and CEO. “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.”

Clinical evidence

The study in Headache evaluated 45 episodic and chronic migraine patients ages 12 to 17 who completed at least one treatment with Nerivio. A total of 159 migraines were treated over the course of the study, mostly moderate (49%) or severe (33%) at baseline. Two hours after treatment, 71% of subjects reported pain relief and 35% reported freedom from pain, with results sustained at 24 hours in 90% of cases. Roughly 7 in 10 patients experienced improvement in functional ability, defined by the ability to do schoolwork and perform “usual activities,” at two hours post-treatment. There were no device-related serious adverse events.

Jennifer McVige, a physician at the Dent Neurological Institute and one of the investigators in the study said the drug-free migraine therapy could improve compliance among adolescent patients, who are often reluctant to take pills and, at the same time, comfortable with technology. “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.”

Currently, there are about 10,000 active adult patients in the U.S. and a few hundred in Israel, where Nerivio has just started to be used, Alon told BioWorld.

Available via telehealth

The treatment is available through major headache clinics, other licensed health care providers and telemedicine platforms, including New York-based Cove and Upscript, of Scottsdale, Ariz. “We are working on some new direct-to-consumer channels that include teleconsultation,” Ironi said. “The intention is to make the funnel easier and more comfortable for patients, but at the same time provide the telehealth providers with more complete and relevant patient information.”

Nerivio is delivered directly to the patient’s home and is good for 12 treatments, following which is can be recycled and the prescription refilled. Ironi said the company is working with several pharmacy benefit managers and payers, adding some already cover the treatment and others will join.

“Our effort is focused on making it zero dollars out of pocket through most insurance programs,” he said.

As for the new adolescent indication, Ironi said it “provides physicians with a safe, effective, easy-to-use therapy specifically indicated for acute treatment [of migraine]. “If you’re a parent of a teenager, this means that you don’t necessarily have to accept that your child will be on medications for many years, but they have an effective nonpharmacological therapy.”

Theranica has applied for CE mark approval of the adolescent expansion and expects it to be confirmed around March, Ironi said.

The company is also working on an indication for prevention treatment of migraine.

Competition in the space

There are other FDA-approved neuromodulation treatments for episodic migraine and cluster headaches, but not for chronic migraines.

In 2018, Basking Ridge, N.J.-based Electrocore Inc.’s Gammacore was the first such neurostimulator to win FDA clearance to treat cluster headaches. A rechargeable and reloadable version, Gamma Sapphire, is marketed for the treatment of episodic cluster and migraine headaches in adults.

Cefaly sprl, a Belgian medical device company, also targets migraine with its Cefaly neuromodulation device.

In November, the FDA granted breakthrough device designation to Netherlands-based Salvia Bioelectronics BV for its implantable neurostimulation system to treat chronic migraine – underscoring the ongoing need for effective, affordable treatments for the debilitating condition.

Meanwhile, Neurolief Ltd., of Netanya, Israel, reported data in 2019 showing significant relief from migraine following treatment with Revilion, the first noninvasive neuromodulation system that targets two major nerves where migraines originate.