FDA Clears GammaCore for Acute Treatment of Pain Associated with Episodic Cluster Headache in Adult Patients
New Jersey–based electroCore has gained FDA clearance for the use of gammaCore, which is a non-invasive vagus nerve stimulator, for the acute treatment of pain associated with episodic cluster headache in adult patients.
The device transmits a mild electrical stimulation to the vagus nerve through the skin, resulting in a reduction of pain.
The device was cleared based on two clinical-trial-data reports which found that 34.2 percent of patients experienced a reduction in pain from episodic cluster headache compared to 10.6 percent in patients treated with placebo.
The company expects commercial availability of gammaCore in the U.S. early in the third quarter of 2017. — Cynthia Jessup