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FDA Grants Marketing Authorization for Neuromodulation Device for Acute Migraine

May 28, 2019
Nerivio Migra is slated to launch in the United States later this year.

A PPM Brief

FDA granted marketing authorization1 for Theranica Bioelectronics’ (Netanya, HaMerkaz, Israel) noninvasive neuromodulation device, Nerivio Migra, indicated for the relief of acute migraine pain with or without aura in May 2019. Nerivio Migra is a smartphone-based electroceutical worn on the upper arm that utilizes electronic pulses to create a conditioned pain modulation (CPM) response. This approval from FDA comes from positive outcomes from a prospective, randomized, double-blind, placebo-controlled study2 involving 252 patients (from 7 US clinics and 5 Israeli clinics) experiencing 2 to 8 migraines per month.

"[The clinical data] indicates that the device can provide patients with significant relief of pain and other migraine symptoms without the side effects presented by drugs," said Messoud Ashina, MD, PhD, president-elect of the International Headache Society (IHS), in a company news release.

(Source: 123RF)

Participants meeting the International Classification of Headache Disorders (ICHD) criteria for migraine were randomized (1:1) to an active or sham stimulation. Nerivio Migra was applied for 30 to 45 minutes on the upper arm within 1 hour of an attack, and the electrical stimulation was at a perceptible, yet non-painful intensity level. Migraine pain levels were recorded at baseline, 2, and 48 hours post-treatment; most bothersome symptoms (MBS) were also recorded. The primary endpoint was the proportion of participants achieving pain relief at 2 hours post-treatment (improvement from severe/moderate pain to mild or none, or from mild to none). The relief of MBS and freedom from pain at 2 hours post-treatment were also key secondary endpoints.

Active stimulation with Nerivio Migra was significantly more effective than sham stimulation 2 hours post-treatment, specifically with:

  • achieving pain relief (66.7% vs 38.8%; therapeutic gain of 27.9%; P < 0.0001),
  • freedom from pain (37.4% vs 18.4%; P = 0.003),
  • and relief of MBS (46.3% vs 22.2%; P = 0.0008).

In addition, the superiority of the active treatment regarding pain relief and freedom from pain was sustained 48 hours after treatment.

"The results of the study demonstrate a high efficacy ratio for single as well as multiple attacks," said principal investigator Brian Grosberg, MD, director of Hartford Healthcare Headache Center in Connecticut.

Device-related adverse events were low and similar between treatment groups (4.8% vs 2.4%; P = 0.499). According to the release, Theranica plans to launch Nerivio Migra in the US later in 2019.

Last updated on: June 14, 2019
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