FDA Approves Stimulation Therapy Device for Episodic Cluster Headache

Article

The FDA has approved the first noninvasive vagus nerve stimulation device, gammaCore, for the acute treatment of pain from episodic cluster headache in adult patients, the manufacturer electroCore announced in a press release.

The FDA has approved the first noninvasive vagus nerve stimulation device, gammaCore, for the acute treatment of pain from episodic cluster headache in adult patients, the manufacturer electroCore announced in a press release.

The product is a handheld, noninvasive, easy-to-use device that provides a new option for adults with the headache disorder. The device is applied at the neck and works by transmitting a mild electrical stimulation to the vagus nerve through the skin, which reduces associated pain.

The FDA’s release is based on analyses of data from 2 clinical trials, ACT1 and ACT2, which evaluated the safety and efficacy of gammaCore for the acute treatment of episodic cluster headache. Both trials were prospective, double-blind, placebo-controlled, randomized studies that evaluated the use of gammaCore versus a placebo.

The results from ACT1, which evaluated 81 patients, showed that 34.2% of patients experienced a reduction in pain after treatment compared with 10.6% of patients in the placebo group. Results from the ACT2 trial also demonstrated a significantly higher percentage of pain reduction in patients who used the product (47.4%) versus patients treated with a placebo (6.2%).

Both trials also demonstrated gammaCore’s safety and tolerability, with the majority of adverse events being mild and transient and occurring during the time of active treatment.

“The FDA release of gammaCore is an important advance in the treatment of pain associated with cluster headache,” Stephen Silberstein, MD, Director, Headache Center, Jefferson University, said in a press release. “It is a way for patients to treat their symptoms as often as they need to use the device.”

Reference

FDA releases gammaCore, the first non-invasive vagus nerve stimulation therapy applied at the neck for acute treatment of associated with episodic cluster headache in adult patients [news release]. electroCore’s website. http://www.electrocore.com/fda-releases-gammacore-the-first-non-invasive-vagus-nerve-stimulation-therapy-applied-at-the-neck-for-acute-treatment-of-pain-associated-with-episodic-cluster-headache-in-adult-patients. Accessed April 18, 2017.

Related Videos
Close up hands of helping hands elderly home care. Mother and daughter. Mental health and elderly care concept - Image credit:  ipopba | stock.adobe.com
Rear view of Audience listening Speakers on the stage in the conference hall or seminar meeting, business and education about investment concept -  Image credit: THANANIT | stock.adobe.com
Pharmacist helping patient use glucose monitor -- Image credit: Kalyakan | stock.adobe.com
Pride flags during pride event -- Image credit: ink drop | stock.adobe.com
Female Pharmacist Holding Tablet PC - Image credit: Tyler Olson | stock.adobe.com
African American male pharmacist using digital tablet during inventory in pharmacy - Image credit: sofiko14 | stock.adobe.com
Young woman using smart phone,Social media concept. - Image credit: Urupong | stock.adobe.com
selling mental health medication to man at pharmacy | Image Credit: Syda Productions - stock.adobe.com
Medicine tablets on counting tray with counting spatula at pharmacy | Image Credit: sutlafk - stock.adobe.com
© 2024 MJH Life Sciences

All rights reserved.