The non-invasive vagus nerve stimulator’s OK marks the first approval for cluster headache of any kind.
The FDA has cleared the use of the gammaCore non-invasive vagus nerve stimulator (VNS) therapy for adjunctive preventive treatment of cluster headache in adult patients, making it the first and only product approved for the prevention of cluster headache as no pharmacologic options are available, according to manufacturer electroCore.1
The device was previously approved in January 2018 for the treatment of migraine pain in adults, which expanded its original 2017 label from just its use for episodic cluster headache pain.
“The FDA clearance of gammaCore for adjunctive use for the preventive treatment of cluster headache has the potential to help the approximately 350,000 Americans impacted by this debilitating condition often referred to as a ‘suicide headache,’” said Frank Amato, MBA, the chief executive officer at electroCore. “We are pleased that cluster headache patients now have a[n] FDA-cleared option and one that is both safe and effective, especially given the difficulty in treating cluster headache and the limitations of current treatments.”
The approval for this most recent indication was supported by the results of a pair of studies, the PREVA trial, which assessed the stimulator in a group of 93 patients. In the trial, those who received standard treatment plus the gammaCore device (n = 45) reported greater reductions in mean cluster attacks per week (-5.9 attacks) than the control group (n = 48; -2.1 attacks), which received only standard of care (P
In a site-adjusted model, study investigators reported that the mean therapeutic gain for the device was 4.2 fewer attacks per week (P
= .02). Additionally, of the patients who received the gammaCore device in addition to standard of care, 40% experienced a ≥50% reduction in weekly cluster headache attacks, compared to 8.3% in the control group (P
In terms of the needs for abortive medicine, there was a 57% decrease in the frequency of abortive medication use among those utilizing the VNS device (P
<.001) compared to an insubstantial reduction in abortive medicine use for those in the control group (P
As for adverse events (AEs), the therapeutic device is considered well tolerated. In the PREVA trial, the incidence of AEs was similar between the 2 groups, and the majority of AEs were mild and transient. The most common AEs, occurring in ≥5% of patients in the gammaCore group, were headache (8%), dizziness (6%), and neck pain (6%). None of the serious AEs experienced were deemed device-related.
In a cost-effectiveness study of the PREVA data, conducted in Germany, the gammaCore device was found to be cost-effective in comparison with current standard of care, which suggests that adjunctive VNS therapy provides economic benefits in the treatment of chronic cluster headache.2
The investigators noted that their analysis included only costs associated with abortive treatments, and that treatment with the device will likely stimulate further economic benefit when other potential sources of cost savings, such as reduced frequency of clinic visits, are contemplated.
It is recommended that to prevent cluster headache, adult patients should self-administer two gammaCore treatments daily. Each treatment consists of 3 consecutive 2-minute stimulations. The first treatment is recommended to be applied within 1 hour of waking up and the second treatment should be applied at least 7-10 hours later, according to electroCore.
1. electroCore Receives FDA Clearance for gammaCore™ (nVNS) for Adjunctive Use for the Preventive Treatment of Cluster Headache in Adults [press release]. Basking Ridge, NJ: electroCore, Inc; Published November 28, 2018. investor.electrocore.com/news-releases/news-release-details/electrocore-receives-fda-clearance-gammacoretm-nvns-adjunctive. Accessed December 5, 2018.
2. Morris J, Straube A, Diener HC. Cost-effectiveness analysis of non-invasive vagus nerve stimulation for the treatment of chronic cluster headache. J Headache Pain. 2016;17:43. doi: 10.1186/s10194-016-0633-x.