ibusinesslines.com
ibusinesslines.com August 23, 2017


FDA approves electroCore's treatment for cluster headaches

20 April 2017, 03:27 | Melissa Porter

FDA approves electroCore's treatment for cluster headaches

FDA approves electroCore's treatment for cluster headaches

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.



Other News

Trending Now

As Le Pen loses ground, Sarkozy tells voters to choose Fillon
A new survey published yesterday showed Macron leading on 23 per cent to Le Pen's 22.5 per cent - both of them down slightly. Le Pen has pressed hard on her anti-immigration, anti-globalisation message as she seeks to mobilise voters.

Thunder Extra: Thunder-Rockets storylines
When he was asked about winning his second scoring title in three years , he hesitated, then simply replied: "Next question". The Thunder, on the other hand, shoot only 25.8 3-pointers a game and make only 8.4 of those attempts on a nightly basis.

Why Wenger MUST start Giroud for Arsenal v Middlesborough
On Saturday, Middlesbrough visit 16th-placed Bournemouth, who have slipped into the relegation scrap having failed to register a victory in their last four league games.

Some vets can go to CVS 'MinuteClinics' for minor illnesses
Since then, the VA has made several efforts to improve veteran wait times , including establishing the Veterans Choice Program. The tool displays the percentage of patients who reported that they always or usually obtain an appointment when needed.

Soyuz space capsule carrying American, Russian blasts off
An American and Russian blasted off in a Soyuz rocket from the Baikonur Cosmodrome in Kazakhstan on April 20. While it is Yurchikin's fifth mission to the space station, Fischer is on his first.

Petition against Sisters of Charity ownership of NMH goes viral
Campaigners argue that the religious organisation's failure to compensate abuse victims should prevent their involvement. The Minister for Health insists that medics working in the new facility will be independent.

National Football League star gatecrashes Sean Spicer's press briefing
Quarterback Tom Brady did not attend the visit, citing " personal family matters " as the reason for his absence. The team presented Trump with a personalized Patriots jersey and a championship helmet.