In May, the FDA granted de novo clearance to Theranica’s smartphone-controlled device for acute migraine treatment, Nerivio Migra. This month, it was named to TIME Magazine’s annual list of top 100 best inventions.1,2

In its supporting clinical trial, the primary end point of pain relief at 2 hours post-treatment demonstrated a 66.7% response rate in the Nerivio Migra group versus 38.8% in the placebo group (<.0001). Additionally, of the 4 secondary and exploratory outcome measures, 3 were statistically significant—the percentage of those pain-free at 2 hours post-treatment (37.4% active versus 18.4% placebo; <.004), the relief of the most bothersome symptom out of phonophobia, photophobia, and nausea at 2 hours post-treatment (46.3% versus 22.2%; <.001), and relief of both pain and most bothersome symptom at 2 hours post-treatment (40% versus 15.2%; <.0005).3

To find out more about the clinical experience with the device, NeurologyLive sought the insight of 3 experts in the field of migraine: Amaal Starling, MD, assistant professor of neurology at Mayo Clinic Scottsdale; Stephen Silberstein, MD, professor of neurology, Thomas Jefferson University, and director, Jefferson Headache Center; and Jessica Ailani, MD, director, MedStar Georgetown Headache Center. Each of them offered their individual thoughts on their use of the device and its potential in migraine.

NeurologyLive: If you have experience with the device, what was that experience like?

Amaal Starling, MD: At this time, my clinical experience with this device is limited. I just started prescribing this device about 2 weeks ago. What I have learned so far from a clinical perspective is that it is important to discuss the underlying mechanism by which this device works as well as physically demonstrate the use of the device to obtain patient “buy-in.” Otherwise, patients are skeptical to use the device because they feel like it may just be a distraction rather than modulation of descending pain modulation via the brainstem. In addition, patients may be concerned, worried about, or scared to use something that provides sub-threshold electrical stimulation to the arm. Thus, it is very important to do a show and tell of this device, and honestly, any other neuromodulation devices.

However, I have not had any patients return for a follow-up visit yet, so I am unable to discuss my own clinical experience with the efficacy and tolerability of this device within my own patient population.

Stephen Silberstein, MD: Yes, I have some, and the experience was extremely positive. Many patients have tried it in office and had relief. They’ve reported back that they really felt it worked for them.

Jessica Ailani, MD: It just became available for prescription. My experience has been that patients are interested in trying the device, its novel mechanism of action (to activate the brain’s natural blocking mechanism for pain—which is an over-simplification, but makes sense to patients), is appealing to them and to me.

What do you believe its potential is as a treatment alternative in migraine?

Amaal Starling, MD: Based on the data, it has great potential for being an acute treatment for migraine attacks. It appears to be well tolerated and effective when treating a migraine attack early in the attack process. I am hoping that this will be an option for patients with frequent migraine attacks in efforts to reduce the use of oral medications for acute attacks. Given that oral acute medications, when used too frequently, can contribute to the complication of medication overuse, having an additional option for acute migraine attacks without the risk of medication overuse is essential. This device and other neuromodulation devices are exactly those additional options.

In addition, there are 30% to 40% of patients for whom triptan medications are ineffective. I am hoping that this device and other neuromodulation devices—as well as the new acute migraine treatment options that have been recently FDA-approved and are currently in the pipeline—will help serve that patient population who desperately need something new for the acute treatment of migraine attacks.

Stephen Silberstein MD: It is safe, and effective, and does not interact with anything in the bloodstream. There is no reason the device couldn’t be a first-line treatment for all migraine.

Jessica Ailani, MD: Considering the need for more diverse options for acute migraine treatment, and data that is compelling for Nerivio, I believe this device has a role in treating acute migraine attacks in people who have either failed standard of care (triptans) due to ineffective or side effects, are seeking non-medication options, or have a high frequency of attacks and need safe options to use frequently.

Transcripts edited for clarity.
REFERENCES
1. FDA Grants Theranica De Novo to Market First Smartphone-controlled Acute Migraine-relief Wearable Device [press release]. Netanya, Israel: Theranica; May 28, 2019. prnewswire.com/news-releases/fda-grants-theranica-de-novo-to-market-first-smartphone-controlled--acute-migraine-relief-wearable-device-300857281.html. Accessed November 26, 2019.
2. Park, A. Zapping Migraines: Theranica Nerivio. TIME website. Published November 21, 2019. time.com/collection/best-inventions-2019/5733097/theranica-nerivio/Accessed November 26, 2019.
3. Theranica Announces Results from Pivotal Study of Device for Treating Acute Migraine [press release]. Scottsdale, Arizona: Theranica Bio-Electronics; November 15, 2018. prnewswire.com/news-releases/theranica-announces-results-from-pivotal-study-of-device-for-treating-acute-migraine-832012898.html. Accessed November 26, 2019.