The development comes after a study showed users had four fewer days per month with migraine symptoms.
A prominent digital therapeutics firm has won clearance from the FDA to market its migraine therapy not only as a treatment for acute migraines, but also as a tool to help prevent migraine episodes.
The regulatory victory for Nerivio, which is marketed by the firm Theranica, marks a significant step forward for the prescription digital therapeutics (PDT) industry as developers seek to show how this type of therapy can fill unmet medical needs.
“We are hopeful this expanded dual-use indication will have a tremendous impact on mitigating the burden of migraine symptoms and improving patient quality of life,” said Alon Ironi, M.S., Theranica’s co-founder and chief executive, in a press release.
Nerivio is a device worn on the upper arm and controlled by an application on the patient’s smartphone. As a drug-free alternative to migraine therapy, the device uses remote electrical modulation (REN) to activate the patient’s peripheral nerves, which in turn activates the body’s internal pain-management mechanism called conditioned pain modulation.
The company recommends patients self-administer a 45-minute treatment every other day to help prevent migraines, or else at the start of a migraine episode in order to treat the acute episode.
Nerivio first received FDA clearance to treat migraine in adults in 2019, using the agency’s De Novo pathway. Two years ago, the FDA expanded the product’s clearance to also include adolescents ages 12 and older. Two months after that decision, Theranica announced that it had surpassed 100,000 treatments in the US. The new preventative treatment indication also covers both adults and adolescents 12 and older.
In a study published in January in the journal Headache, investigators reported that patients who used Nerivio had a significant decrease in the number of days per month they experienced a migraine.
The study included 248 patients, of whom 128 were randomized to receive Nerivio and the rest given a placebo. Patients participated in a 4-week observation phase, followed by an 8-week intervention phase. They were asked to keep daily journals of their symptoms.
At the end of the trial period, the company reported that patients using Nerivio experienced 4.0 fewer migraine days per month, compared to a reduction of 1.3 days in the placebo group. When the investigators broke patients into subgroups based on whether their migraines were chronic or episodic, they found similar results: 4.7 fewer days per month for chronic migraine patients versus 1.6 fewer days in the placebo group, and 3.2 fewer days for patients with episodic migraines compared with 1.0 days in the placebo group.
In a subgroup analysis of patients who were taking preventive medications, the reduction was 3.5 days per month compared to .5 days in the placebo group.
The expanded indication comes as Theranica and other prescription digital therapeutics makers are pushing to expand access to their products through partnerships with insurers and other firms. In the past year, the company has announced deals with Costco, Point32Health, and Highmark Inc., to provide the therapy to their members.
In January, the company said it would partner with Dr. Reddy’s Laboratories to market the product in India if the therapy is approved by regulators there.
In addition to the REN therapy, the Nerivio app also includes features designed to help patients track symptoms and set reminders to take other medications. It also has an feature that guides users through techniques such as diaphragmatic breathing, muscle relaxation, and guided imagery, the company said.
“While there is an established desire for effective nondrug options, especially for adolescents, migraine care needs to treat the whole person given the nature of this long-term disease,” Ironi said. “With this in mind, we developed an innovative wearable with a personalized wraparound care plan.”