ElectroCore received a 510(k) clearance from the FDA to expand the use of its noninvasive nerve stimulator device for the prevention of cluster headaches.
The prescription-only adjunctive treatment uses a mild electrical charge to stimulate the vagus nerve at the base of the neck. The hand-held gammaCore device has previously been cleared for the acute treatment of pain from episodic cluster headaches and migraines in adults.
About 350,000 people in the U.S. are impacted by cluster headaches, sometimes referred to as suicide headaches, electroCore CEO Frank Amato said in a statement.
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The Basking Ridge, New Jersey-based company also announced plans this week to expand into a new design, development and manufacturing facility to support gammaCore’s commercialization efforts.
The new FDA clearance was supported by results from two studies: a prospective, open-label study and a retrospective review of real-world data stemming from gammaCore’s daily clinical use.
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In the first study, patients who used the gammaCore device and received the standard of care saw nearly six fewer cluster attacks per week on average, compared to the two fewer attacks seen by those receiving the standard of care alone.
To prevent cluster headaches, electroCore says patients should self-administer two treatments daily, consisting of three consecutive two-minute stimulations, with the first treatment applied within one hour of waking up and the second seven to 10 hours later. The device has not been shown to be effective for preventing migraines.