FDA approves Theranica’s smartphone-controlled electroceutical device for migraine
pharmafile | May 29, 2019 | News story | Research and Development | FDA, Nerivio Migra, Theranica, migraine, pharma
Biomedical tech company Theranica has secured FDA approval for Nerivio Migra, its wearable, smartphone-controlled electroceutical device, for the acute treatment of migraine in patients with or without aura who do not have chronic migraine.
Placed on the upper arm, Nerivio Migra creates a Conditioned Pain Modulation (CPM) response through electronic pulses, promising “significant relief” of pain or migraine symptoms without the side-effects of drug treatment – a key concern when a study of 2,444 people recently showed that around two-thirds delayed or avoided taking medications because of side-effects, while 79% sought treatments with similar efficacy but fewer side-effects.
“Physicians who treat people with migraine are both patient-centred and science-driven,” said Professor Stephen Silberstein, Director of the Headache Center at the Jefferson University Hospital in Philadelphia, a member of the medical advisory board of Theranica. “Over the last 20 years my colleagues and I have used triptans and ergots for acute migraine treatment. There is a large unmet need for new treatments in this population when these medications are not effective, are contra-indicated, or have non-tolerable side effects. In addition, triptans and most current acute migraine medications, including over-the-counter drugs indicated for migraine, are associated with medication-overuse headache (MOH), which is associated with increased frequency of migraine attacks, and often results in chronic migraine. This new innovative FDA-authorised treatment is an important alternative to help our patients control this debilitating condition.”
The FDA’s decision was based on data which showed that, when tested in 252 participants across 12 clinics, 66.7% achieved pain relief response within two hours when using the technology.
“This study followed the latest edition of the guidelines from the International Headache Society for controlled trials of acute treatment of migraine attacks in adults,” added Dr Brian Grosberg, Director of the Hartford Healthcare Headache Center in Connecticut, and lead Principal Investigator of the study. “The results of the study demonstrate a high efficacy ratio for single as well as multiple attacks, both at two and 48 hours after treatment.”
Alon Ironi, CEO and co-founder of Theranica, commented: “While the company is preparing to launch the Nerivio Migra in the United States market later this year at an affordable price, we remain committed to continuing our clinical development, expanding the use of remote electrical neuromodulation therapy for additional indications. We have identified at least seven different painful conditions that may be relieved by this non-invasive, drug-free technology after appropriate clinical development.”
With a global prevalence of 14.7%, migraine is the third most common disease in the world, costing around $17 billion each year in the US alone.
Matt Fellows
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