Theranica has announced a new peer-reviewed study analysing the efficacy, safety and sustainability of remote electrical neuromodulation (REN) as a standalone, and medication-adjunct, treatment of migraine. The real-world evidence study, which is published in Frontiers in Pain Research, concludes that REN—administered via Theranica’s flagship product, Nerivio—performs well across all three of these parameters.
Results from an analysis of more than 23,000 treatments, collected over a period of 19 months, demonstrated significant efficacy of REN, according to a Theranica press release. In 66.5% of the treatments, REN was used as a standalone treatment and, in approximately 80% of the treatments, no other prescribed medication was used.
Out of 2,514 patients included in the efficacy analysis, 32% of the episodic migraine patients and 21% of the chronic migraine patients achieved pain freedom two hours post-treatment in most of their treatments, and more than 65% experienced sustained pain relief post-two hours.
In the safety analysis, only 59 of the 12,368 participants (0.48%) reported any device-related adverse events—the vast majority of which were mild (56) with no reports of any severe events.
“Migraine, a disabling chronic condition, affects 12% of the population,” said Jessica Ailani, director of the MedStar Georgetown Headache Center and professor of clinical neurology in the Department of Neurology, and lead author of the study. “While some people with migraine get relief from prescribed or even over-the-counter medications, others do not respond to medications, or cannot tolerate their side-effects.
“There are also people who cannot use medications due to contraindications, or being at risk of drug-drug interactions or medication overuse headache. The current analysis of a very large group of patients, over a long period of time and multiple treatments, reinforces that REN provides a safe, efficacious and stable treatment option for acute treatment of migraine, both as a standalone and as an adjunct therapy. This is a very important component in the migraine therapy toolbox.”
Worn on the upper arm at the onset of a migraine attack, Nerivio alleviates migraine headache and associated symptoms by utilising REN to trigger an endogenous analgesic mechanism—known as conditioned pain modulation (CPM)—the Theranica release adds. The device is controlled via a smartphone app, allowing patients to set the intensity of their treatment as well as maintain a built-in migraine diary that can easily be shared with physicians for improved migraine tracking and management.
“To the best of our knowledge, this study is the largest prospective, real-world evidence analysis of a migraine device to date,” said Alon Ironi, CEO of Theranica.
“This kind of long time, large-population, real-world data are exactly the type of evidence required by health insurance organisations to feel confident about a new therapy in the market,” added Scott Serota, former CEO of Blue Cross Blue Shield Association, who serves on Theranica’s board of directors.
Nerivio is a prescribed, digitally connected wearable. Clinical studies have shown that it is effective and safe for the treatment of episodic and chronic migraine in individuals aged 12 and older, the release concludes.