The Food and Drug Administration (FDA) has expanded the approval of Nerivio® (Theranica) to include acute treatment of migraine with or without aura in patients aged 18 years and older with chronic migraine. Previously, the device had only been approved in those with episodic migraine.
Nerivio is a wireless remote electrical neuromodulation (REN) device designed to be self-applied to the upper arm. The prescription device uses electrical pulses to stimulate C and Aδ nociceptive sensory fibers of the upper arm to activate the brain’s conditioned pain modulation response to treat pain and migraine symptoms. It is controlled by a smartphone application that allows the user to adjust the stimulation intensity, monitor the duration of treatment, and pause or stop the stimulation. The app also includes a migraine diary, which can be shared between patients and health care professionals.
The clearance was supported by data from 2 multicenter, open-label, single-arm clinical studies (TCH-005 and TCH-006) that evaluated the efficacy and safety of Nerivio for the acute treatment of migraine with or without aura in patients with chronic migraine (greater than 15 headache days per month).
Findings from TCH-005 showed that 50% (n=19/38) and 26.3% (n=10/38) of patients achieved pain relief and were pain-free at 2 hours, respectively. Among patients who achieved pain relief at 2 hours, 83.3% (n=10/12) demonstrated sustained pain relief for 24 hours (7 patients did not report pain level at 24 hours and were excluded from analysis).
In TCH-006, 59.3% (n=54/91) and 20.9% (n=19/91) of patients achieved pain relief and were pain-free at 2 hours, respectively. Among patients who achieved pain relief at 2 hours, 73.3% (n=33/45) demonstrated sustained pain relief for 24 hours (9 patients did not report pain level at 24 hours and were excluded from analysis).
Additionally, both studies showed that the device was safe to use and was well tolerated.
“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,” said Prof. Stephen Silberstein, MD, director of the Headache Center at the Jefferson University Hospital in Philadelphia, who also serves on Theranica’s Medical Advisory Board. “Availability of an additional treatment option such as Nerivio provides an important additional tool to address this patient population.”
The Nerivio device is contraindicated for use in patients with congestive heart failure, severe cardiac or cerebrovascular disease, uncontrolled epilepsy, or in those with an active implantable medical device (ie, pacemaker, hearing aid implant).
For more information visit theranica.com.
- Nerivio® receives clearance of expanded indication to cover chronic migraine patients. [press release]. Montclair, NJ: Theranica; October 26, 2020.
- Theranica website. https://theranica.com/technology/#clinical-data. Accessed October 27, 2020.