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10.27.20

FDA Grants Expanded Clearance for Chronic Migraine to Remote Electronic Neuromodulation

  • KEYWORDS:
  • Headache
  • Migraine

The Food and Drug Administration (FDA) gave clearance for the additional indication of treating chronic migraine in adults to remote electronic neuromodulation (REN) device (Nerivio; Theranica, Montclair, NJ). The device, which is worn on the upper arm during treatment, now has clearance for use in acute treatment of both chronic and episodic migraine with or without aura. The clearance is supported by results from 2 clinical studies (NCT04161807 and NCT04194008) involving a neural conditioned pain modulation (CPM), or intrinsic pain inhibition.

In an open-label pilot study, results of which were published in Pain & Therapy, 38 participants with chronic migraine with or without aura received REN or sham treatment with the device. With REN, 73.7% (28/38) of participants achieved pain relief at 2 hours and 26.3% (10/38) achieved pain freedom for at least half of their REN-treated attacks. Consistent pain relief at 24 hours was experienced by 84.4% (32/38) and 45% (17/38) had sustained pain relief at 24 hours in at least 50% of their treated attacks. Incidence of device-related adverse events was less than 2%.

A prescription can be obtained through any licensed healthcare provider, including via online telemedicine consultation platforms, and can be delivered directly to the patient's home. Each device is good for 12 treatments, after which it can be recycled, and the prescription refilled with a new dispensed device.

"Since the neurotransmitters released as a result of REN triggering the CPM mechanism are strong analgesics, it is not surprising to see evidence that this treatment approach is effective in chronic migraine patients as well," said Rami Burstein, PhD, professor of Anesthesia, Harvard Medical School, and vice chair of neuroscience in the department of Anesthesia, Critical Care and Pain Medicine in Beth Israel Deaconess Medical Center in Boston, who also serves on Theranica's medical advisory board. 

"With this indication expansion, Theranica is now broadening market access of Nerivio in the USA, including health insurance reimbursement," said Theranica chief executive officer Alon Ironi. "It's time to provide physicians and patients affordable access to a safe nonpharmacological acute treatment."
 

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