After winning FDA approval in October 2020, the new expanded indication includes adolescents aged 12 and older with episodic or chronic migraine.
Theranica announced today that the FDA has cleared an expanded indication of its remote electrical neuromodulation (REN) Nerivio migraine device for acute treatment of episodic or chronic migraine in adolescents aged 12 years and older.1
Recently published data from a single-arm, multicenter study of adolescents aged 12 to 17 years with migraine was the basis for the decision. The study included 45 participants with episodic and chronic migraine who completed a test treatment with the REN and found there to be only 1 device-related adverse event (AE; 2%) which was a temporary feeling of pain in the arm.2
"Having this drug-free migraine therapy available for the adolescent migraine community could positively impact patient compliance,” Jennifer McVige, MD, MA, pediatric neurologist, DENT Neurologic Institute, and investigators of the safety study, said in a statement.
According to the study published in Headache, pain relief and pain freedom at 2 hours were achieved by 71% (28 of 39 participants) and 35% (14 of 39) of participants, respectively. There were also no device-related serious AEs found.
The investigators treated 159 migraine headaches with the device over the course of the study, most of them either moderate (n = 78; 49%) or severe (n = 52; 33%) at baseline. Sustainability of pain relief and pain freedom for 24 hours was found in 90% of the cases. Improvements in functional ability at 2 hours, defined by ability to do schoolwork and perform “usual activities” were found in 69% of the participants (23 of 33).
"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. As a mother of two teenagers with migraine, and someone who sees many adolescents in my practice, Nerivio is a promising new option with potential to help thousands of young patients,” McVige added.
Nerivio is the first FDA-cleared smartphone-controlled prescription wearable device for acute migraine treatment of episodic or chronic migraine in people 12 years and older and received its initial approval in October 2020. At the time, it was only approved for patients aged 18 years and older.3
Each Nerivio device is good to use for 12 treatments, after which a newly dispensed device can be given to fill prescriptions. The device can be recycled upon the need to discard it. The prescription device is self-applied to the upper-arm and is used in the home environment at the onset of migraine headache or aura. It gained national recognition in November 2019 after it was named to TIME Magazine’s annual list of top 100 best inventions. Nerivio is also available by prescription by any licensed healthcare provider and can be accessed on telemedicine platforms such as Cove and UpScript.
"This new indication is a dramatic step in our committed effort to serve the migraine community as a whole,” Alon Ironi, chief executive officer, co-founder, Theranica said 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.”