We are very excited to be interviewing Neurolief about Relivion, a device that has recently received FDA clearance and is yet to be rolled out to treat migraine. Relivion is a neuromodulation system which is something that we at Innovation in Migraine see as an extremely interesting path for the treatment of migraine – read on to hear about how it works and what kind of results Relivion has produced so far.
Neurolief develops proprietary digital therapeutic brain neuromodulation technology to treat neurological and neuropsychiatric disorders such as migraine and depression. The company’s devices either complement or provide an alternative to pharmaceutical therapies, which are often associated with potential short and long-term adverse effects.
The Neurolief technology is intended to provide a highly effective, safe and side effect-free treatment for the hundreds of millions of patients worldwide. Relivion® currently has FDA clearance and CE Mark for the treatment of migraine, and future indications for Neurolief’s technology include depression, insomnia, ADHD and additional chronic pain and neuropsychiatric disorders.
What is Relivion®? (for treatment of Migraine)
Relivion® is the first non-invasive multi-channel brain neuromodulation system for at home treatment of acute migraine.
Relivion received FDA clearance in February 2021 and will enter the US market through a limited market release in the fall of 2021 followed by a full market release in the first half of 2022.
How does it work?
Neuromodulation is clinically proven to alter brain function through targeted, delivery of currents to the central nervous system. The Relivion offers precise, personalized care by delivering stimulation to six branches of the occipital and trigeminal nerves via the three adaptive output channels of the device. This stimulation creates a cumulative effect by releasing neurotransmitters in the brainstem and modulates brain networks associated with control of pain.
Can you share some information on the efficacy of Relivion?
“The FDA clearance of the Relivion® is an important event for those suffering from migraines, as it is the only neuromodulation technology thus far that has demonstrated statistically significant efficacy in providing complete freedom of migraine symptoms within 2 hours after treatment, in a sham-controlled clinical trial,” said Stewart J. Tepper, MD, Professor of Neurology at the Geisel School of Medicine at Dartmouth, who was the principal investigator on the pivotal international trial. “Patients will now have access to a highly effective, easy-to-use, non-invasive, and drug free therapeutic option that will help them regain control of their lives.”
The FDA marketing clearance is based on the results of a multi-center, prospective, randomized, double-blind, placebo-controlled clinical study. Forty-six percent (46%) of the patients in the active group reached complete pain freedom compared to only 11.8% of patients in the control group. Seventy five percent (75%) of patients in the active group reached complete freedom of “Most Bothersome Symptom” (MBS, which is defined as either phonophobia, photophobia, or nausea), within 2 hours following treatment, compared to 46.7% in the control group. Complete freedom of migraine symptoms (freedom from pain as well as freedom from MBS) at 2 hours after treatment was significantly higher in the active group than in the control group (47.2% ver. 11.1%). Pain relief was also significantly higher in the active group than in the control group at 2 hours after treatment (60% vs. 37%). No serious adverse events were reported. Patients started using either the Relivion® or a “placebo” device with lower treatment intensity, at the onset of their migraine episode for up to one hour. Patients were able to treat several migraine episodes during the course of the trial. The study, RIME, was conducted at leading clinical centers in the US and Israel and evaluated the safety and efficacy of the device with 131 patients who met the International Classification of Headache Disorders (ICHD-3) criteria of migraine with or without aura.
How is Relivion innovative?
Relivion® is the first non-invasive multi-channel brain neuromodulation system for at home treatment of acute migraine and has demonstrated unparalleled clinical results as reflected in the data from the RIME trial. This highly effective treatment is realized without the risks and costs correlated with invasive procedures and without the side effects associated with medications.
The Relivion System also has a cloud-based interface that allows the physician to remotely monitor their patient and optimize the treatment based on an AI driven recommendation. This feedback loop allows for greater personalization in migraine treatment and gives the physician more insight into their patient’s care.
What is Neurolief’s vision for people living with migraine?
Our vision is a world where people suffering from migraine can continue to live normal pain free lives.
What other innovations or research in migraine are you really excited about at the moment?
We will begin our US clinical trial to study Relivion as a preventative therapy for migraine in the coming months. We are excited because our initial clinical evaluation of this indication has returned very promising results.
If you could share one message about migraine to the wider community, what would it be?
The debilitating nature of migraine is real. Neurolief is committed to continuing to innovate, not only our technology, but access to these therapies so patients will have more options for managing their migraines.
We would like to thank Neurolief for letting us interview them and we are excited to see the Relivion system roll out from Fall 2021 and hope that many people with migraine are able to try and find relief with the Relivion system.