Cefaly Wearable Migraine Treatment Now Available Without Prescription

The US FDA has officially cleared the Cefaly Dual neuromodulation device as an over-the-counter product for both the acute and preventive treatment of migraine in adults. Previously only available by prescription, the trigeminal nerve stimulator will be available for purchase by the general public beginning October 13, 2020.¹

The Cefaly Dual kit, which includes the Cefaly device, 1 electrode (good for up to 20 uses), power adapter and charging cable, and storage case typically retails for $499. Three-packs of additional electrodes are available for $25 or via a cost-saving subscription service.

“It's our mission to provide consumers with increased access to an effective and safe dual modality migraine treatment that is scientifically proven to reduce the number of monthly migraine days by almost half," said Jennifer Trainor-McDermott, CEO of CEFALY Technology, in a statement.¹

The device was first granted marketing approval in the US in March 2014 for the prevention of migraine in adults based on clinical data from 2 studies. The first, published in Neurology,² demonstrated a significant reduction in mean migraine days in those who were randomly assigned to 20 minutes of daily treatment with the Cefaly device versus sham treatment over 3 months, with more than 38% of patients in the active treatment group achieving 50% responder rate compared with 12.1% in the sham group. In addition, monthly migraine attacks, monthly headache days, and monthly acute anti-migraine drug intake were all significantly reduced in the treatment group compared with the sham group. Notably, no adverse events were recorded in either group.

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