The Theranica Biotherapeutics remote electrical neuromodulation device is now cleared for the acute treatment of migraine with or without aura in adults, without limitation to episodic migraine.
Theranica Biotherapeutics has announced that its Nerivio medical device has received clearance from the FDA for an expansion on its treatment indication to include the acute treatment of chronic migraine in patients aged 18 years and older.1
This new indication means the device is now cleared to use in the acute treatment of migraine with or without aura in individuals aged 18 years or older, regardless of episodic or chronic migraine classification. The FDA’s decision was made based on the results of 2 clinical studies in chronic migraine.
“The updated Nerivio indication is an important development for patients with chronic migraine,” said Stephen Silberstein, MD, director, Headache Center, Jefferson University Hospital, in a statement. “When chronic patients find an effective treatment, they must limit its use every month to avoid loss of effectiveness and a risk of medication overuse headache. [The] availability of an additional treatment option such as Nerivio provides an important additional tool to address this patient population.
“With over 1000 treatments by 130 chronic migraine patients across 2 open-label studies with Nerivio, the data is clinically relevant,” Silberstein added.
Each Nerivio device is good to use for 12 treatments, after which a newly dispensed device can be given to fill prescriptions. The device can be recycled upon the need to discard it. It 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. It gained national recognition in November 2019 after it was named to TIME Magazine’s annual list of top 100 best inventions.
“With this indication expansion, Theranica is now broadening market access of Nerivio in the USA, including health insurance reimbursement. It’s time to provide physicians and patients affordable access to a safe non-pharmacological acute treatment,” said Alon Ironi, chief executive officer, Theranica, in a statement.
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. In April, Theranica announced that the device was becoming available in the United States on UpScript’s direct-to-patient telemedicine platform. 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.2
Patients who have already been prescribed Nerivio by their doctors can save time and money with the partnership with UpScript, Theranica noted. Those who feel they may be a good candidate can begin the process by going to the UpScript website, here.
The user-friendly app for the device offers 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.3
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.
Additionally, real-world data published in September 2020 suggest that patients treated with the remote electrical neuromodulation (REN) device derive meaningful clinical benefits with minimal adverse effects. All told, that data stratified patients based on the type of visit and provider they received treatment from, including headache specialists (HS; n = 1123) or virtual visits with nonheadache specialists (NHS; n = 31).4
The data revealed that 58.9% (n = 662) and 74.2% (n = 23) of the HS and NHS groups reported pain relief at 2 hours for ≥50% of their treated attacks. Additionally, 20% (n = 268) and 35.6% (n = 16) of the groups, respectively, experienced pain freedom at 2 hours in ≥50% of treated attacks. The effects of the device on associated symptoms and improvement in function were also consistent in both groups.