What You Should Know:
– Theranica, a prescribed digital therapeutics company developing advanced electroceuticals for migraine and other pain conditions, announced today the publication of a new peer-reviewed study analyzing the efficacy, safety and sustainability of remote electrical neuromodulation (REN) as a standalone, and medication adjunct, treatment of migraine.
– The real-world evidence study published in Frontiers in Pain Research Journal concludes that REN, administered by Theranica’s flagship product Nerivio®, performs well across all three parameters.
Impact of Migraines on Americans
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. Some patients cannot use medications due to contraindications or being at risk of drug-drug interactions or medication overuse headache.
Peer-Reviewed Real World Study Results
Results from an analysis of over 23,000 treatments, collected over a period of 19 months, demonstrated significant efficacy of REN. In 66.5% of the treatments, REN was used as a standalone treatment. 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 over 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, MD, 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.”
How Nerivio’s Migraine Device Works
Nerivio is a prescribed, digitally connected wearable. Clinical studies have shown that Nerivio is effective and safe for the treatment of episodic and chronic migraine in individuals aged 12 and older. Worn on the upper arm at the onset of a migraine attack, Nerivio alleviates migraine headache and associated symptoms by utilizing REN to trigger an endogenous analgesic mechanism, known as conditioned pain modulation (CPM). 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.
