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The device will now be available with prescription through Azova’s Collaborative Clinical Care Platform for those with migraine.
Cefaly Technology, the makers of the FDA-approved Cefaly migraine treatment device, have announced a partnership with Azova’s Collaborative Clinical Care Platform to expand access to the Cefaly Dual migraine device.
The platform allows patients across the country to set up online visits with health care providers and a prescription when appropriate. The company noted that patients can access their free eVisit with a healthcare provider to see if they are a good candidate to use the Cefaly Dual device at their joint website, cefalyus.azova.com.
"We are excited to provide a way for people to find quality care and relief quickly, particularly given the current environment and the added complications in seeking in-person medical care," said Jennifer Trainor-McDermott, CEO, Cefaly Technology. “This new telemedicine partnership affords patients same-day virtual medical appointments.”
The device was approved for preventive use in March 2014 and for abortive use in September 2017. It offers these options in the formats of its 60-minute acute setting for use upon migraine onset, and 20-minute prevent setting for daily use to help prevent future episodes. It is non-invasive and placed on the forehead to modify pain sensation in the area research identifies as a center for migraine pain, the trigeminal nerve.
The company noted that when it is deemed that a patient could benefit from the device, the online provider will send the prescription directly to Cefaly, which eliminates “a time-consuming step in the customer process.” Then, by simply ordering the device from the company’s website, it can be shipped to their front door.
"We're happy to help people with migraines access effective treatments more quickly and conveniently from the comfort of their homes," said Cheryl Lee Eberting, MD, CEO and founder, Azova.
In July 2019, data from an open-label, monocenter, prospective pilot trial suggested that the device is both safe and effective as a prophylactic treatment for patients with chronic migraine. All told, both the frequency of headache days and the intake of acute medication were decreased with the use of a daily, single 20-minute eTNS session over the course of 3 months.2
In total, 58 patients at the University of Colorado Anschutz Medical Campus were included in the study. Of those, 58.6% (n = 34) had noncontinuous headache, while 41.4% (n = 24) suffered from continuous headache. Continuous headache was defined as meeting the criteria for chronic migraine and being uninterrupted by pain-freedom for >3 hours, ≥5 days per month. Additionally, 59.6% (n = 33) of patients fulfilled the criteria for medication overuse headache.
The monthly frequency of headache days was reduced by 16.21%, from 22.55 days to 19.43 days (P <.001) in the overall cohort. For those with noncontinuous headache, the frequency of headache days was reduced by 24.38% (P <.001) while those with continuous headache reported a decrease of 4.62%. As for the mean use of monthly acute medication, the total cohort saw a significant reduction of 30.81%, from 26.33 to 18.22 days (P <.001). In the subgroup with continuous headache, this reduction was more significant (11.85%) than the subgroup with noncontinuous headache (5.47%), although the baseline use of acute medication was higher at baseline, at 32.92 ±41.08, for the continuous headache group compared to the noncontinuous group, at 21.68 ±18.71.
Additionally, investigators conducted 2 other studies to demonstrate the Cefaly device’s effectiveness. The first, the PREMICE study, included 67 patients who had at least 2 migraine attacks per month. There was a significant decrease in the number of migraine days per month, with minimal AEs, in the patients who used the Cefaly device. Results from a subsequent larger survey conducted in patients who used the Cefaly device for 40 days showed that a little more than half found it helpful.3,4
1. CEFALY Technology Partners with AZOVA Telemedicine Platform for Virtual Migraine Treatment Prescriptions [press release]. New York, NY: Cefaly; Published June 8, 2020. Accessed June 12, 2020. prnewswire.com/news-releases/cefaly-technology-partners-with-azova-telemedicine-platform-for-virtual-migraine-treatment-prescriptions-301071741.html
2. Birlea B, Penning S, Callahan K, Schoenen. Efficacy and safety of external trigeminal neurostimulation in the prevention of chronic migraine: An open-label trial. Cephalagia. Published online June 18, 2019. doi: 10.1177/2515816319856625.
3. Schoenen J, Vandersmissen B, Jeangette S, et al. Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial. Neurology. 2013;80(8):697-704. doi: 10.1212/WNL.0b013e3182825055.
4. Russo A, Tessitore A, Conte F, Marcuccio L, Giordano A, Tedeschi G. Transcutaneous supraorbital neurostimulation in “de novo” patients with migraine without aura: the first Italian experience. J Headache Pain. 2015;16(1):69. doi: 10.1186/s10194-015-0551-3.