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FDA Approves First Preventive Treatment for Cluster Headache

The stimulator gammaCore well tolerated in two studies

A PPM Brief

electroCore (Basking Ridge, NJ) has announced1 the FDA’s clearance of an expanded label for its gammaCore therapy, a non-invasive vagus nerve stimulator [nVNS]) aimed at adjunctive use in the prevention of cluster headache in adult patients. The approval makes the stimulator the first and only FDA-approved device cleared for the prevention of cluster headache, according to a company news release.

The clearance is based on the results of two studies: the PREVA (Prevention and Acute treatment of chronic cluster headache) pivotal study, a randomized clinical trial that demonstrated the safety and effectiveness of gammaCore, and a retrospective study examining the daily clinical use of gammaCore preventively and acutely for the treatment of cluster headache.

“We are pleased that cluster headache patients now have a 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,” said Frank Amato, CEO of electroCore, in the release.

Cluster HeadachegammaCore is the first non-invasive, hand-held medical therapy applied at the neck as a therapy to prevent cluster headache. (Source: 123RF)

In the PREVA study, intention-to-treat (ITT) patients who received the standard of care and gammaCore (SoC plus nVNS, n = 45; control, n = 48) during the randomized phase had a greater reduction from baseline (-5.9) in the number of cluster attacks per week than those receiving just SoC (-2.1), for a mean of 3.9 fewer cluster attacks per week (P = 0.02). In the site-adjusted model, the mean therapeutic gain was 4.2 fewer attacks per week (P = 0.02).

Approximately 40% of patients who received SoC plus nVNS experienced a 50% or greater reduction in weekly cluster attacks, compared to 8.3% of patients who received SoC alone (P < 0.001). There was also a 57% decrease in the frequency of abortive medication use among patients who received SoC plus nVNS (P < 0.001), while patients who received SoC alone did not experience a substantial reduction in abortive medication use (P = 0.59). The stimulator was found to be safe and well tolerated, as the majority of adverse events were mild (serious events were considered not device-related). The most commonly reported events in 5% of patients from the gammaCore group were headache (8%), dizziness (6%) and neck pain (6%).

Indication involves the self-administration of two gammaCore treatments per day, consisting of three consecutive 2-minute stimulations. The first treatment is to be applied within one hour of waking up while the second treatment is to be applied at least 7 to 10 hours later. The product is available by prescription only.

Last updated on: December 4, 2018
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