Apr 23, 2018 | Updated: 09:54 AM EDT

FDA Approves gammaCore: A Therapy Device Which Reliefs Headache Pain in Minutes

Apr 19, 2017 10:43 AM EDT

Periodic headaches is a vulnerable issue often seen among a vast number of people. There are ample medicines existing to debar this problem. But also most of these come with massive and long-term side effects. For the first time, the U.S. Food and Drug Administration (FDA) has approved such an electronic device which can reduce the pain of a headache without harming any area of the human body. FDA just gave the green signal to gammaCore, the first-ever noninvasive vagus nerve stimulation device, made by the neuro-electronic technology master: electroCore.

According to PR Newswire, gammaCore has been specifically made to provide acute treatment from episodic cluster headache issues from adults. It is a pure handheld and noninvasive device that, when applied to the neck, produces mild electronic stimulations through the skin, which transfers through vagus nerve and reliefs the pain associated with a headache. The device is very handy & easy to use and headache affected patients can run it on their own. Regarding gammaCore, Stephen Silberstein, MD, Director, Headache Center, Jefferson University, Philadelphia, PA recently stated. "The FDA release of gammaCore is an important advance in the treatment of the pain associated with cluster headache."

As per a report by Pharmacy Times, the FDA gave the approval to gammCore after testing it on two parameters: ACT1 and ACT2. Both the trials were examined on prospective, double-blind, placebo-controlled manner, providing a potential evaluation on the comparison of the effects of the device and Placebo-based treatments. In ACT1, 85 patients were taken in consideration among which 34.2 percent people claimed to feel the reduction in pain raised from headaches within just 15 minutes unlike the other who relied on Placebo treatment.

In ACT2, 27 patients with 182 headache attack issues were evaluated. Among them, a 47.4 percent popularity, who used gammaCore reported getting relief from pain within a very short span of time. FDA held both the trails on the basis of tolerability and safety measures. After getting fruitful results from gammaCore, FDA approved the device to be used by the public.

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