The device is the first FDA-approved trigeminal nerve stimulator for migraine treatment available without a 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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In 2017, the FDA approved an expanded indication for the device to be used for acute relief of migraine with or without aura in adults.3 That approval was based on results of the ACME trial (NCT02590939), which included 106 patients experiencing an acute migraine attack who were randomly assigned to active or sham treatment for 1 hour.4 The active treatment group reported nearly a 60% reduction in pain intensity at 1-hour treatment compared with a 30% reduction in the sham group (P <.0001). Notably, those with migraine without aura recorded a greater reduction in pain intensity versus the sham group compared to those with migraine with aura, who experienced a numerical but not statistically significant reduction in pain intensity versus the sham group. No serious adverse events were reported.
Neuromodulation for migraine has become increasingly popular as patients seek out non-pharmaceutical options to address their acute and chronic migraines. The available approved devices, which currently include Cefaly, the gammaCore vagus nerve stimulator, sTMS mini, which is a transcranial magnetic stimulator, and the Nerivio remote electrical neuromodulator, provide effective alternative treatment options for patients who may have contraindications to more typical oral or injectable migraine therapies.