Posted on Jan 11, 2019, 4 p.m.
The US FDA has approved ElectroCore Inc’s hand held vagus nerve stimulator gammaCore for noninvasive adjunctive use in the prevention of cluster headaches in adults, available by prescription only, as published in Medscape Medical News.
GammaCore is placed over the vagus nerve in the neck to release a mild electric stimulation to nerve afferent fibre which may lead to reduction of pain. This is the first product to be cleared by the FDA for the prevention of cluster headaches; the device was already approved for treatment of episodic cluster and migraine headaches in adults in April 2017.
Clearance for adjunctive use in the preventive treatment of cluster headaches has potential to help some 350,000 Americans impacted by this debilitating condition. Electrocore suggests to help prevent cluster headaches adults should self administer 2 daily treatments of 3 consecutive two minute stimulations; first treatment applied within an hour of waking and the second at 7-10 hours later.
Approval by the FDA was based on positive safety and efficacy data from the PRECA study, and data from a real world retrospective study examining daily clinic use preventively and acutely for treatment of cluster headaches. The PREVA study saw a greater reduction from baseline in the number of cluster headaches attacks per week among those receiving treatment with the device over those receiving standard care for a therapeutic gain of 3.9 fewer attacks per week; 40% of those using the device in addition to standard care experienced a 50% reduction in weekly attacks; and gammaCore was also associated with 75% decrease in the frequency of abortive headache medication.
Majority of adverse side effects were mild and transient reported in 5% or more of the participants; with the most common being headaches, dizziness, and neck pain; none of the serious adverse events were considered to be device related.
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