09/11/2018 13:40:40

NICE publishes advice on gammaCore for the treatment of cluster headache in the UK

Report contributors agreed gammaCore was highly innovative, may be more effective than standard of care alone, and has the potential to save money through the NHS by reducing the cost of treating cluster headache

BASKING RIDGE, N.J., Nov. 09, 2018 (GLOBE NEWSWIRE) --  electroCore, Inc., commercial-stage bioelectronic company, today announced that the National Institute for Health and Care Excellence (NICE) has published a Medtech Innovation Briefing (MIB) on their non-invasive vagus nerve stimulator (nVNS), gammaCore, for use in the treatment of cluster headache in adults. The report collates the most recent published evidence, and surmises that gammaCore is beneficial for people suffering with cluster headache. Clinical specialists propose that gammaCore has the potential to be a treatment option for people who haven’t responded to, or can’t tolerate currently available treatments.[1]  

Cluster headache is an excruciating primary headache disorder that is frequently nicknamed “suicide headache” due to its severity,[2] and has recently been recognized by the NHS as one of the top 20 most painful conditions known to man.[3] It is estimated to cost the NHS in England more than £10,000 a year per patient,[4] and affects approximately 66,000 people in the UK.1

“Cluster headache can have a devastating impact on a person’s quality of life,” said Dr. Nick Silver, Consultant Neurologist, The Walton Centre. “The publication of this MIB means that healthcare professionals can now have the confidence to prescribe gammaCore for appropriate patients. The MIB indicates that gammaCore has no known side effects and is easy to use to help prevent cluster headache or alleviate their pain, enabling patients to engage in normal activities such as returning to work and spending time with their friends and families.”

A MIB is a report developed by NICE to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies. The information provided includes a description of the technology, how it’s used and its potential role in the treatment pathway.

The opinion of three leading clinical experts and the advocacy group, Migraine Trust, were consulted in the development of the MIB. The report showed that the use of gammaCore alongside standard of care may be more effective than standard of care only in the treatment of cluster headaches. It also states that gammaCore does not need to be surgically implanted and does not require clinical monitoring.1  

“We are encouraged by the findings of the report which reiterate that gammaCore is an effective treatment option for adults with this highly debilitating condition,” said Francis R. Amato, Chief Executive Officer of electroCore. “Healthcare organizations using gammaCore can help to empower patients to take control of their condition by self-administering nVNS therapy. electroCore will continue to partner with NICE to ensure that our technology is routinely available to eligible patients on the NHS.”

gammaCore modifies pain signals by stimulating the vagus nerve through the transmission of a mild electrical signal. It can be used either to prevent cluster headache from occurring, or can be used to treat pain during a headache. As a hand-held, portable device, the technology allows patients to self-care from the comfort and privacy of a home environment, which could help to alleviate hospital-setting pressures.

About gammaCore™

gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck that acutely treats the pain associated with episodic cluster headache and migraine in adult patients through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore is released/cleared in the U.S. for the acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients.

About electroCore

electroCore, Inc. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology and rheumatology. The company’s initial targets are the acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.  

Investors:

Greg Chodaczek or Lynn Lewis

Gilmartin Group

(646) 924-1769

 investors@electrocore.com 

Media Contact

Alexandra Canale

GCI Health

(617) 921-9353

alexandra.canale@gcihealth.com

[1]

 NICE. Medtech Innovation Briefing. gammaCore for cluster headache.

[2]

 Torelli. Pain and behaviour in cluster headache. A prospective study and review of the literature. Funct Neurol. 2003 Oct-Dec;18(4):205-10

[3]

 NHS Choices. 20 Painful Health Conditions. Available at: https://www.nhs.uk/live-well/healthy-body/20-painful-health-conditions/ Accessed: September 2018

[4]

 Gaul, C., Finken, J., Biermann, J., Mostardt, S., Diener, H-C., Muller, O., Wasem, J., Neumann, A. Treatment costs and indirect costs of cluster headache: A health economics analysis.Cephalalgia: International Headache Society 2011, 31 (16): 1664–1672.

[5]

 electroCore, Inc. (2016). gammaCore: Instructions for Use for gammaCore®. Basking Ridge, NJ.

EC-Logo-2018_TM_CMYK.jpg

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