The US Food and Drug Administration (FDA) has cleared the hand-held, noninvasive vagus nerve stimulator gammaCore (electroCore Inc) for adjunctive use in the prevention of cluster headache in adults, the company announced.
The device is already approved for the treatment of episodic cluster headache and migraine in adults, as previously reported by Medscape Medical News.
The gammaCore device is placed over the vagus nerve in the neck, where it releases a mild electrical stimulation to the nerve's afferent fibers, which may lead to a reduction of pain in patients. It is the first and only product approved by the FDA for the prevention of cluster headache.
“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," Frank Amato, CEO at electroCore, said in the company's news release.
According to the company, to help prevent cluster headache, adults should self-administer two gammaCore treatments daily. Each treatment consists of three consecutive 2-minute stimulations. The first treatment should be applied within 1 hour of waking up and the second at least 7 to 10 hours later. gammaCore is available by prescription only.
FDA approval of the device as an adjunctive therapy for the prevention of cluster headache was based on positive safety and efficacy data from the PREVA study, as well as data from a real-world retrospective study examining the daily clinical use of gammaCore preventively and acutely for the treatment of cluster headache, the company said.
In the PREVA study, patients who received standard of care plus gammaCore treatments saw a greater reduction from baseline in the number of cluster headache attacks per week than those receiving standard of care only (−5.9 vs −2.1), for a therapeutic gain of 3.9 fewer cluster attacks per week (P = .02).
In addition, 40% of patients who received gammaCore treatment in addition to standard of care experienced at least a 50% reduction in weekly cluster attacks compared with 8.3% of patients who received standard of care alone (P < .001). Use of gammaCore was also associated with a 57% decrease in the frequency of abortive headache medication.
The majority of adverse events associated with gammaCore were mild and transient. The most common adverse events reported in 5% of patients or more in the gammaCore group were headache (8%), dizziness (6%), and neck pain (6%). None of the serious adverse events were considered device-related.
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Cite this: FDA OKs Vagus Nerve Stimulator to Prevent Cluster Headaches - Medscape - Dec 03, 2018.