NICE Recommends the Use of gammaCore for the Treatment of Cluster Headache in the NHS

NICE has today published a medical technologies guidance document recommending the use of gammaCore within the NHS for the acute and preventive treatment of cluster headache in the U.K.

LONDON and BASKING RIDGE, N.J., Dec. 03, 2019 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that the UK’s National Institute for Health and Care Excellence (NICE) has published its medical technologies guidance for National Health Service (NHS) professionals titled, ‘gammaCore for Cluster Headache’ recommending the use of gammaCore, a non-invasive vagus nerve stimulator (nVNS), for the acute and preventive treatment of cluster headache in adults. Independent committees, including professionals and lay members, have developed this evidence-based recommendation in consultation with relevant stakeholders. The full guidance can be found https://www.nice.org.uk/guidance/mtg46.

The guidance document (MTG46) affirms that gammaCore, when used with standard of care, reduces the frequency and intensity of cluster headache attacks, and consequently the use of acute medications. This is likely to lead to significant quality of life benefits for people living with this condition. The NICE guidance states that gammaCore, when added to standard of care, can save an average of £450 per patient in the first year of treatment through a reduction in acute rescue medications use, and with electroCore offering no cost evaluations for all patients. In addition, gammaCore is likely to lead to a reduced need for other NHS resources and their associated costs since people for whom it is effective will be able to better manage their condition at home.

Among the comments received by NICE in their review of gammaCore are endorsements from UK neurologists expressing strong support for patient access to gammaCore in the NHS, such as “This device has changed the way we practice – it has huge implications beyond the results of headache diaries,” and “[I have] had a lot of experience with seeing clinical responses and the meaningful and significant impact this treatment can commonly have on people’s lives.”

“We are delighted with the recommendations made by NICE and we hope this guidance will enable patients in the UK to access our therapy more readily. Approximately 66,000 people in the UK suffer from this devastating headache disorder, and experts have reported that 25-50% of the most severely affected will benefit from our therapy,” said Iain Strickland, Managing Director of electroCore UK, Ltd. “This NICE guidance enables headache specialists within the NHS to offer gammaCore as a much-needed alternative treatment option, which may lead to a dramatic improvement in many patients’ quality of life. I would like to thank all of the headache specialists, patients affected by cluster headache, and the Organisation for the Understanding of Cluster Headache (OUCH), who, amongst many others, shared their experiences of both cluster headache and gammaCore, as part of the NICE consultation process.”

About gammaCore

gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache 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 CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults. gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute treatment of pain associated with migraine headache in adult patients.

  • Safety and efficacy of gammaCore have not been evaluated in the following patients: 
    — Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device 
    — Patients diagnosed with narrowing of the arteries (carotid atherosclerosis) 
    — Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy) 
    — Pediatric patients 
    — Pregnant women 
    — Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
  • Patients should not use gammaCore if they: 
    — Have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck 
    — Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)

In the US, the FDA has not cleared gammaCore for the acute treatment of chronic cluster headache or the preventative treatment of migraine headache.

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

About electroCore UK, Ltd.

electroCore UK, Ltd. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation (nVNS) therapy initially focused on the treatment of multiple conditions in neurology and rheumatology. The company’s primary focus in the UK is the use of gammaCore for the treatment of cluster headache and migraine. electroCore UK, Ltd. is a subsidiary of electroCore, Inc. Basking Ridge, New Jersey, USA.

For more information, visit electrocore.com.

Forward-Looking Statement

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and product development plans, its pipeline or potential markets for its technologies, and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.