Nerivio®

Product Overview

Medical conditions:

Migraine

Target patient population:

For migraine patients with or without aura, 12 years of age or older. For those seeking a clinically-proven drug-free solution, or those that do not respond to prescribed medications and/or cannot tolerate their side-effects.

What to expect:

Provides significant pain relief to 7 out of 10, and pain freedom to 4 out of 10 patients treated with Nerivio.

Note: for more information, please visit https://nerivio.com/.

Clinical Overview

Indications for use:

Nerivio® is a non-pharmacological, non- invasive, wireless, wearable, battery-operated, remote electrical neuromodulation (REN) stimulation device for the treatment of migraine. Nerivio is self-administered by the patient, controlled by a smartphone app, and FDA cleared for acute treatment of migraine with or without aura in patients 12 years of age or older.

Outcomes:

Nerivio has been proven effective in two prospective double-blinded sham controlled randomized controlled trials (RCTs). 66.7% achieved pain relief [p< 0.0001] and 37.4% achieved pain freedom [p<0.005]

Directions:

Nerivio device is a wireless wearable battery-operated stimulation unit controlled by a smartphone software application. Treatments with Nerivio are self-administered by the user at the onset of a migraine attack.
a) Nerivio is applied to the upper arm as soon as a migraine begins
b) Treatment is started and the intensity is adjusted to a “tingling” that is not painful
c) 45 minutes is the recommended treatment time

Risks & warnings:

Nerivio should not be used by people with congestive heart failure, severe cardiac or cerebrovascular disease, or uncontrolled epilepsy. Nerivio should not be used by anyone with active implantable medical devices (e.g. pacemaker, hearing aid implant).

Place in therapy:

Nerivio can either replace current therapy or work in conjunction with existing

Product Access

Product description:

Nerivio device is a wireless wearable battery-operated stimulation unit controlled by a smartphone software application. Treatments with Nerivio are self-administered by the user at the onset of a migraine attack. Nerivio is fully operated by an app, controlling the treatment, providing fully-featured migraine diary, personalized analytics and tips for the patient and more.

Prescription status:

A prescription from a qualified healthcare provider is required.

Patient access:

Patients obtain a prescription from their healthcare provider or via a telemedicine service. Nerivio is sent to patient’s home within 24-48 hours. Patients download the Nerivio app, register and log-in, and start using Nerivio to treat their migraines.

Provider access:

Healthcare providers may access their patients migraine diary by having the patient share the info from within the app. A dedicated Nerivio-HCP dashboard is under development to allow providers access to monitor their patients migraine trends, potential medication-related issues, and view patient-generated health data. This dashboard will be accessible through the Nerivio clinician web portal.
Nerivio is also integrated with many of major EHRs to ensure that data is securely shared with the patient record.

Coverage options:

The company is actively pursuing options for reimbursement to ensure patients have access to this product.

Product availability:

Nerivio is available in:

• EU: CE mark (MDR) credentialed by Dekra (class IIa)
• USA: De Novo FDA-authorization

Clinical Trials

The provided set of evidence represents a sample of conducted studies. For a comprehensive collection contact manufacturers directly.

• Study Title: Real-World Analysis of Remote Electrical Neuromodulation (REN) for the Acute Treatment of Migraine – 2022
  Study Design: Prospective, real-world evidence
  Outcomes: REN provides an efficacious, stable, and safe treatment option for acute treatment of migraine in real-world settings. Out of 2,514 patients, pain relief and pain freedom in at least 50% of treatments were achieved in 66.5% and 22.6% of the patients, respectively. Device related adverse events were reported by 0.48% out of 12,368 users (121,947 treatments). REN also may reduce medication usage, as out of 23,151 treatments, in 66.5% REN was used as a standalone treatment, in 12.9% it was followed by over-the-counter medications, and in 20.6% followed by prescription medications.
• Study Title: Safety and efficacy of remote electrical neuromodulation for the acute treatment of chronic migraine: an open-label study – 2021
  Study Design: Prospective, multi-center, open-label trial
  Outcomes: Pain relief and pain disappearance at 2 hours were achieved by 59.3% (54/91) and 20.9% (19/91) of modified intent-to-treat subjects, respectively (with worst-case sensitivity analysis indicating 54.5% and 19.2%, respectively). Sustained pain relief at 24 hours was observed in 64.4% (29/45) of those who achieved pain relief at 2 hours (with worst-case sensitivity analysis indicating 45.6%).
• Study Title: Comparison of Remote Electrical Neuromodulation and Standard-Care Medications for Acute Treatment of Migraine in Adolescents: A Post Hoc Analysis – 2021
  Study Design: Prospective post-hoc analysis
  Outcomes: REN may have higher efficacy than certain standard-care medications for the acute treatment of migraine in adolescents. Pain freedom was achieved by >1/3 (37.1%) pts with REN compared with 8.6% of pts with medications.
• Study Title: Remote Electrical Neuromodulation (REN) for the Acute Treatment of Menstrual Migraine: a Retrospective Survey Study of Effectiveness and Tolerability – 2021
  Study Design: Retrospective, survey study
  Outcomes: REN may provide a safe, non-pharmacological alternative for the acute treatment of menstrual migraine. 100% of the participants reported REN treatment is at least moderately tolerable, nearly 75% reported that REN was at least moderately effective, and 45% reported satisfaction.
• Study Title: Remote Electrical Neuromodulation for the Acute Treatment of Chronic Migraine – 2021
  Study Design: Prospective, open label
  Outcomes: REN results in the relief of pain and associated symptoms in patients with chronic migraine. 59.3% pts achieved pain relief at 2h, 20.9% were pain-free at 2h, effects sustained for 24h.
• Study Title: Real-world Experience with Remote Electrical Neuromodulation in the Acute Treatment of Migraine – 2020
  Study Design: Prospective, real-world evidence
  Clinical Outcomes: Real-world data confirm that REN results in meaningful clinical benefits (n=1339) with minimal side effects (n=4725). 59.3% pts achieved pain relief at 2h, 20.5% were pain-free at 2h, effects sustained for 24h. The incidence of device-related adverse events was very low (0.5%).
• Study Title:Remote Electrical Neuromodulation for the Acute Treatment of Migraine in Patients with Chronic Migraine: An Open-Label Pilot Study – 2020
  Study Design: Prospective, open-label
  Clinical Outcomes: REN may offer an effective, safe, and well tolerated acute treatment in patients with chronic migraine. >2/3 (73.7%) pts achieved pain relief at 2h, 26.3% were pain-free at 2h, effects sustained for 24h, and were consistent across consecutive attacks.
• Study Title: Remote electrical neuromodulation for acute treatment of migraine in adolescents – 2020
  Study Design: Prospective, open-label
  Clinical Outcomes: REN may offer a safe and effective non-pharmacological alternative for acute treatment in adolescents. >2/3 (71%) pts achieved pain relief, >1/3 (35.%) were pain free, and >2/3 (69%) experience improved functional ability at 2h.
• Study Title: Incorporating Remote Electrical Neuromodulation (REN) Into Usual Care Reduces Acute Migraine Medication Use: An Open-Label Extension Study – 2020
  Study Design: Prospective, open-label
  Clinical Outcomes: REN may reduce the use of acute migraine medications. 89.7% pts avoided medications in all attacks & treated only with REN, compared with 15.4% who avoided medications before REN introduced to REN.
• Study Title:Remote electrical neuromodulation (REN) in the acute treatment of migraine: a comparison with usual care and acute migraine medications – 2019
  Study Design: Prospective post-hoc analysis
  Clinical Outcomes: REN treatment leads to pain relief at 2h in more participants than usual care (66.7% versus 52.%).
• Study Title: Remote Electrical Neuromodulation (REN) Relieves Acute Migraine: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial – 2019
  Study Design: Prospective, triple-blind, sham-controlled
  Clinical Outcomes: REN provides superior clinically meaningful relief of migraine pain and MBS compared to placebo, offering a safe and effective non-pharmacological alternative for acute migraine treatment. 2/3 (66.7%) participants achieved pain relief at 2h, >1/3 (38.%) were pain free at 2h, and nearly 1/2 (46.3%) achieved relief of their most bothersome symptoms (MBS) at 2h, all significantly more than sham. Effects are independent of baseline pain severity and sustained for 48h.
• Study Title: Nonpainful remote electrical stimulation alleviates episodic migraine pain – 2017
  Study Design: Prospective, double-blind, sham-controlled
  Clinical Outcomes: Nonpainful REN can significantly reduce migraine pain, especially when applied early in an attack.