Nerivio Device: New Approval and Real World Evidence

More good news about Nerivio (formerly Nerivio Migra), an electrical neuromodulation (REN) device to fight migraine attacks. We have some new information from real-world usage, and we have a new approval in the USA thanks to some other positive trials.

Nerivio is a clever device that hit the market about a year ago. It’s a patch that goes on your arm, which is controlled by your smart phone. It’s used to fight your migraine symptoms when an attack has started.

Originally approved for episodic migraine, researchers went on to see how it would work for chronic migraine. Two new studies – open label – showed that half or more patients had some relief from pain after two hours, and 20% or more were completely pain free after two hours (and the vast majority of those remained pain-free).

Although there is likely to be a high placebo effect in an open-label study, there’s more good news – the device seems to be very safe and well-tolerated. Read more here: Nerivio Device Cleared for Use in Patients With Chronic Migraine

And so the FDA in the USA has approved Nerivio for use with chronic migraine patients, not just episodic. This is great news for those who want to try Nerivio, even if they have more frequent attacks.

But after a year, how is Nerivio working for patients with episodic migraine? Patients were checked from two groups. One group had in-person visits with a migraine specialist, another had virtual visits with a non-headache specialist.

In the first group, 58.9% were pain free at the two hour mark in at least 50% of their attacks, and in the second group 74.2% were pain free at two hours in at least 50% of their attacks. (Before you decide to never visit a specialist again, these were not groups the researchers divided up. It’s likely that the headache specialist group were simply patients with harder to treat migraine – meaning that 58.9% headache-free is actually a really good number!) A large number were not pain-free, but had significant pain reduction. (Details here – Real-world Experience with Remote Electrical Neuromodulation in the Acute Treatment of Migraine.)

Once again, perhaps the best news of all – only 0.5% experienced a side effect from the device. That’s really low, if you compare it with most of the drug treatments available.

So in short – Nerivio is now officially approved for chronic migraine in the USA, it works well for some patients, and seems to be very safe and well tolerated so far.

Dr. Alexander Mauskop at the New York Headache Center adds an extra tip for patients and doctors – that they take the time to relax during the treatment. He also notes that many patients find the treatment itself to be relaxing.

Have you tried Nerivio? What’s your experience so far?