ibusinesslines.com May 24, 2018

FDA approves electroCore's treatment for cluster headaches

20 April 2017, 03:27 | Melissa Porter

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Getty Images

The GammaCore device interferes with pain signals transmitted through the vagus nerve, which connects the brain and the gut. 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 which evaluated the use of gammaCore vs. placebo. It promises to relieve the pain of cluster headaches by providing electric stimulation when held against the neck.

Any use of rescue medication within 60 minutes was considered a treatment failure. In ACT2, which included 27 patients with episodic cluster headache, more patients using the VNS system experienced pain reduction compared with placebo (47.5% versus 6.2%, P=0.003). The product is a handheld, noninvasive, easy-to-use device that provides a new option for adults with the headache disorder. And it seems like blocking that path can lead to effective relief: A study published in Headache a year ago found that 27 percent of people with cluster headaches felt better 15 minutes after using it, compared to 15 percent patients who got a placebo. "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", Dr. Stephen Silberstein of Philadelphia's Jefferson University said in a prepared statement. They predominantly affect males and usually manifest by the age of 30.

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