In a study of more than 1500 adolescents, two-thirds of individuals experienced relief from functional disability with Nerivio.
Recently published real-world data from a large-scale sample of adolescents treated with Nerivio, Theranica’s remote electrical neuromodulation (REN) device, showed significant pain relief from severe or moderate headache 2 hours after treatment.
The news comes less than 2 months after the FDA approved the therapy as a dual-use acute and preventive treatment for migraine with or without aura in patients 12 years of age or older. Led by Rashmi Rao, MD, pediatric neurologist, Children’s Hospital New Orleans, the study analyzed prospective real-world data from 1629 adolescents aged 12 to 17 with migraine, treated with Nerivio over a period of a year and a half.
Findings showed that 2 hours after treatment, consistent pain relief response in at least half of their evaluable treatments was found in 60.3% (158 of 262) of users. Furthermore, at this time, consistent pain freedom was attained by 26.3% (76 of 289), consistent functional disability relief by 66.3% (169 of 255), and consistent freedom of functional disability was attained by 41.2% (105 of 255) of the users. When including patients who combined REN with other acute medications for migraine, consistent pain relief was reported in 58.3% (233 of 400) of users, consistent pain freedom by 24.1% (105 of 435), consistent functional disability relief by 68.5% (265 of 387), and consistent freedom of functional disability by 36.7% (142 of 387) of users.
"Migraine must be treated early and holistically, with a comprehensive plan tailored for each child's needs, symptoms, and lifestyle," Rao said in a statement. "For parents and teens, this data adds to established clinical efficacy and demonstrates the significant real-world benefits of Nerivio, either as a standalone therapy or as an adjunct to other treatments, as a valuable non-drug tool to treat migraine."
When assessing REN as a standalone vs an adjunct, investigators found that 64.4% (1524 of 2365) of the treatments REN was the only therapy, while 18.6% (439) combined REN with OTC medications, 7.6% (180) REN was combined with oral triptans, and 9.4% (222) REN was combined with other prescription medications. Between these groups, the efficacy response was similar.
The analysis, which covered 12,862 treatments across 1629 adolescents, revealed an average treatment intensity that was 28.5% (±13.6%) of the max stimulator intensity, with a median of 26.0%. Intensity ranged between 14% and 46% of the max stimulator intensity for 80% of the users. Relative to previous estimates in adults, the average stimulation intensity used in real-world settings by adolescents was slightly lower (mean, 28.5% vs 34.3%). Among all the treatments performed, 3 user reported device-related adverse events, all of which were minor and not serious. These DAEs included tingling and local soreness during or after treatment.
"The brain naturally has the power to shut off pain under certain conditions. We developed Nerivio to empower adolescents and adults with migraine to flip the switch, without being physically obtrusive and with no systemic side effects," Alon Ironi, chief executive officer and president, Theranica, said in a statement. "This real-world evidence, on top of results of our previous studies, shows that using Nerivio as a first-line migraine treatment for young adults is safe, effective, and drug-free, providing essential relief so they can be present in school, social activities, and everyday life."
Since originally receiving its FDA go-ahead in 2019, Nerivio has continued to demonstrate effectiveness in preventive and acute care for migraine treatment in adolescents and adults. The most recent FDA approval for adolescents was supported by results from a randomized placebo-controlled trial published in Headache which demonstrated significant reduction in monthly migraine days and other prevention end points.
The trial consisted of a 4-week baseline observation phase, followed by an 8-week double-blind intervention phase, in which 248 participants used either REN with Nerivio or a placebo wearable every other day. Patients who used Nerivio had a mean reduction of 4 migraine days per month from baseline compared to a reduction of only 1.3 days in the placebo group, a net therapeutic gain of 2.7 days per month. In addition, participants also showed statistically significant reductions from baseline in mean number of headache days of all severities and in number of days on which they required acute migraine medication.