Nerivio Migraine Device Available Through Telemedicine Platform

Peter Ax, JD, MBA

Theranica Bioelectronics announced its FDA-authorized prescribed wearable device for the treatment of migraine, Nerivio, will now be available in the United States on UpScript’s direct-to-patient telemedicine platform.¹

Nerivio was granted De Novo clearance by the FDA in May 2019 for the acute treatment of migraine with or without aura in adults who do not have chronic migraine. Now, patients across all 50 states will have the opportunity to remotely connect with doctors to assess the need for a prescription and order Nerivio directly to their homes.

It gained national recognition in November after it was named to TIME Magazine’s annual list of top 100 best inventions.

"Access to in-person medical care is an escalating challenge for many, especially in remote areas, which is why telehealth options are becoming increasingly important,” Alon Ironi, chief executive officer and co-founder, Theranica, said in a statement. “When someone is suffering from a debilitating condition like migraine, it is imperative that they can access treatment quickly. Part of Theranica's mission is to ensure that Nerivio is both affordable and easily accessible, with the help of advanced online services like UpScript."

Nerivio is a smartphone-controlled electroceutical device that uses non-invasive neuromodulation to create a conditioned pain modulation response. The prescription device is self-applied to the upper-arm and is used in the home environment at the onset of migraine headache or aura.²

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The user-friendly app provides personalized treatments and includes a diary to track treatment sessions and migraine headaches. Clinical trial results showed a 66.7% response rate in the Nerivio group versus 38.8% in the placebo group at 2 hours post-treatment (P <.0001), ultimately supporting the FDA’s authorization.

The same trial showed 46.3% of patients in the Nerivio group experienced relief of the most bothersome symptom compared to 22.2% of patients in the placebo group (P <.0001). Additionally, relief of both pain and most bothersome symptom at 2 hours was found in 40% and 15.2% of Nerivio and placebo groups, respectively.

The announcement saves time and money for patients who have already been prescribed Nerivio by their doctors. Additionally, those who feel they may be a good candidate can begin the process with UpScript by going to their website, here.

"Patients with migraine need care quickly and conveniently," said Peter Ax, JD, MBA, chief executive officer and founder, UpScript, in a statement. "We provide this crucial support through our online consultations and quick-ship options. We are happy to expand our migraine treatment options to include an innovative product like Nerivio, to help people achieve convenient and effective relief from their migraines."

REFERENCE

1. Theranica expands access to prescribed migraine wearable Nerivio through partnership with UpScript health telemedicine platform [news release]. Scottsdale, AZ. April 6, 2020. Accessed April 6, 2020. prnewswire.com/news-releases/theranica-expands-access-to-prescribed-migraine-wearable-nerivio-through-partnership-with-upscript-health-telemedicine-platform-301035804.html

2. Nerivio. Theranica website. Updated 2019. Accessed April 6, 2020. theranica.com/nerivio.