Clinical Data
The safety and efficacy of Nerivio have been consistently demonstrated across a broad patient population, including adults, adolescents, and children with episodic and chronic migraine, as well as pregnant women and those experiencing menstrual migraine. These findings stem from a wide array of clinical studies including randomized controlled trials, open-label trials, real-world evidence studies, survey-based studies, and post-hoc analyses. Results from these studies have been published in leading peer-reviewed journals through original research, health economic research, guidelines, meta-analyses, and review papers.
Nerivio initially received regulatory clearance through the rigorous US FDA De Novo pathway, (DEN180059; May 20, 2019), based on robust clinical evidence demonstrating its safety and efficacy. This De Novo classification then served as the predicate for multiple subsequent 510(k) submissions, ultimately leading to the current expanded indication (K241756; October 8, 2025). The following section includes all studies that were reviewed by the US FDA.
In addition to clinical studies that were submitted to the FDA, many additional studies and post-hoc analyses have been conducted to date across a broad patient population. These include survey-based studies, post-hoc analyses, and real-world evidence studies leveraging the large digital health database of Nerivio (Big Data analysis). These studies were sponsored and led either by Theranica or by other independent organizations.
Nerivio also demonstrated notable health economics and outcomes benefits in both acute and preventive migraine care. Nerivio lead to consistent reductions in medication use, migraine-related disability, productivity loss, and associated costs, across multiple studies, while maintaining high patient satisfaction and safety, making it a compelling treatment option in Health Economics and Outcomes Research (HEOR) terms for patients, providers, and payers alike.