Remote electric neuromodulation device approval extended to treatment of chronic migraine
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The FDA has expanded the approval for Nerivio, a wearable remote electrical neuromodulation device controlled by a smartphone app, to treat chronic migraine in adults aged 18 years and older.
Nerivio, created by the digital therapeutics company Theranica, previously was approved by the FDA for treatment of episodic migraine.
“The updated Nerivio indication is an important development for patients with chronic migraine,” Stephen Silberstein, MD, director of the Headache Center at Jefferson University Hospital in Philadelphia and a member of Theranica's Medical Advisory Board, said in a press release. “When chronic patients find an effective treatment, they must limit its use every month to avoid loss of effectiveness and a risk of medication overuse headache. Availability of an additional treatment option such as Nerivio provides an important additional tool to address this patient population.”
The wearable device uses remote electrical neuromodulation to activate the conditioned pain modulation of the brain to treat pain and other migraine symptoms, according to the press release.
The new clearance was supported by results from two clinical trials of patients with chronic migraine. In a presentation of the findings at this year’s virtual PAINWeek meeting, researchers determined that after using Nerivio, 56.6% of participants achieved pain relief at 2 hours and 22.5% achieved pain freedom. Among these participants, 75.4% experienced sustained pain relief at 24 hours.
According to the press release, the new indication offers a nonpharmaceutical treatment option for patients with chronic migraine, and the device has shown to have similar efficacy to migraine medication without the associated risks for medication overuse in both clinical trials and large-scale post-market surveillance.
Prescriptions for the device — each of which lasts for 12 treatments — can be given by any licensed health care provider during in-person visits or on telemedicine consulting platforms.
“It is so important for people living with chronic migraine to now have access to this effective nonpharmacological therapy,” Nancy Harris Bonk, a migraine patient advocate and educator and COO of Chronic Migraine Awareness Inc, said in the press release. “With migraine attacks occurring so frequently, we, people with chronic migraine, need to be mindful of overusing medications, and identify the right individual balance of therapies that allows us to carry on with our daily routines.”