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05.29.19

FDA Gives Marketing Approval for Smartphone-Controlled Device for Treating Migraine


The Food and Drug Administration (FDA) has granted a de novo request for a smartphone-controlled electroceutical device (Nerivio Migra; Theranica Bio-Electronics, Netanya, Israel) that uses remote electrical neuromodulation for acute treatment of migraine. The device uses electronic pulses to create a conditioned pain modulation (CPM) response to treat migraine with or without aura in adults with episodic migraine. 

The FDA authorization is based on the results of a study published in Headache, in which 252 patients used the device to treat their migraine attacks. The clinical data showed that 66.7% of patients experienced pain relief within 2 hours. The de novo approval process is risk-based, classifying novel medical devices for which there is a reasonable assurance of safety and effectiveness for the intended use.

"Over the last 20 years, my colleagues and I have used triptans and ergots for acute migraine treatment,” said Stephen Silberstein, MD, director of the Headache Center at Jefferson University Hospital in Philadelphia. “There is a large unmet need for new treatments in this population when these medications are not effective, are contra-indicated, or have non-tolerable side effects. In addition, triptans and most current acute migraine medications, including over-the-counter drugs indicated for migraine, are associated with medication-overuse headache (MOH), which is associated with increased frequency of migraine attacks, and often results in chronic migraine. This new, innovative FDA-authorized treatment is an important alternative to help our patients control this debilitating condition."

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