FDA approves medical device to aid cluster headache pain

Hand-held, non-invasive, easy-to-use device provides new option for the approximately 400,000 Americans living with this rare but extremely debilitating headache disorder

The FDA has approved a non-invasive hand held device to treat cluster headaches. The gammaCore by electroCore, transmits mild electrical stimulation to the vagus nerve through skin, resulting in a reduction of pain. It is suitable for the acute treatment of pain associated with episodic cluster headache in adult patients.

“Cluster headache is a rare, debilitating and difficult to treat disorder with few effective acute therapies,” said Stephen Silberstein, director, Headache Center, Jefferson University.

“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.”

Speaking to US News Dr Noah Rosen, headache specialist who directs Northwell Health’s Headache Center, described cluster headaches as “devastating”.

He added: "Although they are uncommon, affecting about 1 in 2,000, they are severe, disabling and poorly understood.”

Rosen explained that as the attacks can occur six or more times a day, they can't effectively be treated with drugs such as sumatriptan safely, given the maximum daily dosage.

It is hoped that the gammaCore device will provide an alternative for at some sufferers of this condition.

gammaCore is currently in use outside of the US including in the European Union. In the US, electroCore expects commercial availability of gammaCore later this year.