gammaCore® gets FDA Approval for Migraine

The Non Invasive Stimulation Device provides A New Treatment Option

Today electroCore announced that its neuromodulation device gammaCore® has received approval by the FDA (US Food and Drug Administration) for the acute treatment of pain associated with migraine in adults. The vagus nerve stimulation device was initially approved by the FDA in April 2017 for the acute treatment of episodic cluster headaches, this announcement marks gammaCore’s first approval for Migraine. gammaCore® (nVNS) is a non-invasive, hand held therapy that is applied at the neck to treat pain associated with episodic cluster headache and migraine by applying electrical stimulation through the skin to activate the vagus nerve.

"Migraine is a debilitating disease affecting 39 million Americans, the majority of whom do not seek medical care for their pain.1 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," said Stephen D. Silberstein, M.D., Professor of Neurology and Director of the Headache Center, Thomas Jefferson University

The FDA approval was supported by the results of the PRESTO (PRospectivE Study of nVNS for the Acute Treatment Of Migraine). trial which demonstrated that treatment with gammaCore for pain associated with migraine was superior to sham, and enabled patients to reach pain freedom more frequently by 30, 60, and 120 minutes. The results further showed that a significantly higher proportion of gammaCore-treated patients achieved pain relief within two hours and the therapy was found to be well tolerated by patients.2

 “With annual healthcare and lost productivity costs associated with migraine measured in the tens of billions of dollars in the U.S., the availability of gammaCore provides patients with a new treatment option to relieve migraine pain, while also offering the potential to alleviate some of the economic strain that arises from their condition as well,” CEO Francis Amato said in a press release.

gammaCore® is also available outside of the US, including in Canada, Uk and Europe. For more information on the treatment and how to access it please contact us.

 


Notes

1 Migraine facts. Migraine Research Foundation. http://migraineresearchfoundation.org/about-migraine/migraine-facts. Accessed January 2018.

2 Tassorelli, C., (September 2017). Non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: a randomized controlled trial. Oral presentation at the Congress of the International Headache Society, Vancouver, Canada.

 

About PRESTO

The multicenter, randomized, double-blind, sham-controlled trial evaluated the efficacy, safety and tolerability of nVNS in 243 patients with episodic migraine. Results from PRESTO found that acute treatment with gammaCore was superior to sham for pain freedom at 30, 60, and 120 minutes: nVNS (n=120) led to significantly higher pain-free rates than sham (n=123) for the first treated migraine attack at 30 minutes (12.7% vs 4.2%; p=0.012) and 60 minutes (21.0% vs 10.0%; p=0.023); however, the improvement at 120 minutes missed statistical significance (30.4% vs 19.7%; p=0.067). A post-hoc repeated-measures test was performed to examine the statistical anomaly between the 120-minute findings and the 30- and 60-minute findings. This test confirmed that gammaCore was superior to sham through 120 minutes (odds ratio: 2.3; 95% CI: 1.2, 4.4; p=0.012). Clinically meaningful and statistically significant benefits from gammaCore therapy were also observed in the secondary endpoints of mild or no pain at 120 minutes (40.8% vs 27.6%; p=0.030) and mean percent pain reduction at 120 minutes (34.8% vs 5.4%; p=0.004). As seen in other published studies, gammaCore was well tolerated, as demonstrated by a low incidence of device-related adverse effects.2 

 

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