The Food and Drug Administration announced April 18 the approval of the gammaCore device to treat pain associated with episodic cluster headache in adult patients.
The agency based its approval of the noninvasive vagus nerve stimulator device on subgroup analyses of episodic cluster headache patients in the ACT1 and ACT2 trials, which were double-blind, placebo-controlled, randomized studies.
In the ACT1 trial of 85 patients, 34.2% experienced a reduction in pain (defined as the percentage of patients who reported mild or no pain 15 minutes after treatment initiation with gammaCore), compared with 10.6% of patients treated with placebo (P = .008). Of 27 patients in the ACT2 trial, 47.5% of patients using the device were pain free at 15 minutes after the onset of pain from cluster headache, with no use of rescue medication through the 30-minute treatment period, which was significantly greater than for placebo (6.2%; P = .003).
In both trials, gammaCore was found to be safe and well tolerated, and the majority of adverse events were mild and transient and occurring during the time of active treatment.
“Cluster headache is a rare, debilitating, and difficult to treat disorder with few effective acute therapies,” Stephen Silberstein, MD, director of the Headache Center at Jefferson University, Philadelphia, said in a statement from the manufacturer, electroCore. “The FDA release of gammaCore is an important advance in the treatment of the pain associated with cluster headache. It is a way for patients to treat their symptoms as often as they need to use the device. It does not have the side effects or dose limitations of commonly prescribed treatments or the need for invasive implantation procedures, which can be inconvenient, costly, and high-risk.”
The gammaCore device works by transmitting a mild electrical stimulation to the vagus nerve through the skin, resulting in a reduction of pain. Currently, gammaCore is in use only outside of the United States, including in the European Union. Commercial availability of gammaCore in the United States is expected to begin early in the third quarter of 2017, the company said.