Trial results on the recently FDA-approved gammaCore device will be presented at the American Academy of Neurology (AAN) annual meeting.
Cristina Tassorelli, MD, PhD
A hand-held device, gammaCore, is the first FDA-cleared, non-invasive vagus nerve stimulation (nVNS) therapy available for the treatment of pain associated with episodic cluster headache and migraine headache.
FDA approval was based on results from the Prospective Study of nVNS for the Acute Treatment of Migraine (PRESTO). Results from PRESTO will be presented during the Headache Platform Session at the American Academy of Neurology (AAN) annual meeting on Thursday, April 26.
PRESTO found that treatment with gammaCore led to significantly higher pain-free rates in treated patients versus the sham patient population at both the 30-minute mark for migraine treatment (12.7% versus 4.2%; P = 0.012) and the 60-minute mark (21.0% versus 10.0%; P = 0.023).
“Migraine is the third most common disease in the world, and one of the 10 most disabling diseases, which highlights a need for novel treatment options,” said Cristina Tassorelli, MD, PhD, Director of the Headache Science Centre, National Neurological Institute C. Mondino Foundation, Professor at the University of Pavia, Pavia, Italy, and principal trial investigator.
The multicenter, double-blind, randomized trial evaluated the efficacy, safety, and tolerability of nVNS in 243 patients with episodic migraine. The study consisted of 3 timeframes, a baseline period where participants used standard of care treatments, a 4-week randomized, controlled, and double-blind period, and a subsequent 4-week open-label period where all participants used the gammaCore device.
The device missed clinical and statistical significance for the study’s primary endpoint, reduction of pain at 120 minutes (nVNS 30.4% versus sham 19.7%; P = 0.067). However, a post hoc repeated-measures test confirmed that nVNS treatment was superior to sham at 120 minutes (odds ratio: 2.3; 95% CI: 1.2, 4.4; p=0.012).
“The PRESTO data suggests that gammaCore was rapidly effective, well tolerated and practical for the acute treatment of episodic migraine. The data supports the use of gammaCore to successfully treat a migraine, making the device a potentially valuable treatment for the millions of people who suffer from migraine,” said Tassorelli.
Secondary endpoints for the study showed clinically meaningful and statistically significant results. These endpoints included mild or no pain at 120 minutes (nVNS 40.8% vs sham 27.6%; p=0.030) and mean percent pain reduction at 120 minutes (nVNS 34.8% vs sham 5.4%; p=0.004).
“Migraine is a debilitating disease affecting 39 million Americans, the majority of whom do not seek medical care for their pain,” said Stephen D. Silberstein, MD, Professor of Neurology and Director of the Headache Center, Thomas Jefferson University. “With the FDA’s decision to release gammaCore for migraine, patients now have access to an effective and safe therapy which can be self-administered to acutely treat the pain associated with migraine.”
The device is already available for the acute treatment of pain due to episodic cluster headache in adults, and electroCore expects commercial availability of gammaCore for the acute treatment of pain associated with migraine headache in adults in the second quarter of 2018.