NJ-ELECTROCORE-LLC

The biannual European Headache and Migraine Trust International Conference (EHMTIC) meeting concluded yesterday in Copenhagen, where more than 900 neurologists and other headache specialists came to hear about the latest advances in managing severe headache conditions, including electroCore’s gammaCore therapy. The attendees heard that a large scale randomized clinical trial of the gammaCore therapy in chronic cluster headache not only significantly reduced the number of cluster headache attacks beyond the best available standard of care, but also that patients experienced a greater reduction in number of attacks the longer they stayed on treatment.

Treatment with gammaCore also resulted in meaningful improvements in quality of life and a reduction in the use of traditional rescue medications such as injectable sumatriptan and oxygen. Cluster headache is a condition that affects approximately the same number of people as multiple sclerosis, and is considered by experts to be one of the most painful medical conditions known to medicine. GammaCore’s demonstrated effects represent a significant breakthrough in the care of patients with this debilitating condition.

More particularly, the Prevention and Acute Treatment of Chronic Cluster Headache (PREVA) randomized and open label trial data were presented in three poster presentations and at a breakout symposium on Saturday evening, highlighting the following key findings:

• Patients receiving gammaCore plus standard of care achieved a 43.4% reduction in the number of weekly cluster headache attacks compared with 12.5% (p=0.002) in patients treated with the best available standard of care.
• Treatment with gammaCore was more effective the longer patients remained on therapy.
• The quality of life measurements measured by EQ-5-3L VAS³ and HIT-6⁴ were meaningful for those on gammaCore.
• Patients on gammaCore (in the randomized phase) reduced their use of sub cutaneous sumatriptan and oxygen by >60%.
• Nearly 64% indicated that they would recommend the use of gammaCore to a family member or friend.
• 56% of patients found treatment with gammaCore very easy to use.
• Treatment with gammaCore was safe and can be used in combination with drug treatments.
• Device related adverse events were primarily mild and transient.

Dr. Charly Gaul, Director of the Migraine and Headache Clinic in Königstein, Germany, who was the principle investigator of the PREVA study, and presented the data from this study during the symposium, commented, “This study is one of the few well controlled, randomized studies of any preventative treatment for cluster headache. The ability of electroCore’s gammaCore therapy to significantly reduce the number of weekly cluster headaches in these chronic patients suggests it offers an important new option for this extremely painful and difficult to manage condition.”

gammaCore is a revolutionary non-invasive vagus nerve stimulation (nVNS) therapy developed by US based healthcare company electroCore. The patient delivers the therapy by holding the device on the neck over the vagus nerve for 90 seconds (link to picture ) which painlessly delivers a proprietary electrical signal that activates specific fibers in the vagus nerve bundle. This stimulates the production of inhibitory transmitters in the central nervous system, and reduces the over expression of the excitatory neurotransmitter glutamate, which has been implicated in a number of headache disorders.

The PREVA trial, which is part of the largest trial program ever carried out in cluster headache, was conducted at ten sites across Europe with 97 patients enrolled. Ninety-three were randomized to participate following the initial baseline data collection. Forty-five of the patients were randomly selected to use gammaCore plus their usual treatment and 48 to the best available standard of care. The baseline data collection period was two-weeks, followed by the four-week randomized phase. All the patients from both arms were asked to continue on active therapy for an additional four-week open label phase.

The dosing of the therapy used in the PREVA trial was three, 120-second stimulations, delivered at two time points during each day.

JP Errico, the Chairman and CEO of electroCore noted: “We are very pleased with the results of the PREVA study. Cluster headache has traditionally been a difficult condition to treat, and it has proven very challenging to prevent the patients from experiencing the attacks that disable them. This prevention trial, part of the largest program ever carried out in cluster patients, shows that our gammaCore therapy can help patients significantly reduce the number of these excruciatingly painful attacks.

“While the gammaCore therapy is presently available in Europe, with a physician’s authorization, under a CE mark covering the treatment and prevention of primary headaches, including both migraine and cluster headache, the PREVA data enable us to go forward and seek reimbursement on behalf of patients, so that it is widely available for the patients who so desperately need it. We are hopeful to receive the necessary approvals to enter the US in 2015.

“This study and the many other studies we are now running prove that nVNS therapy is an effective and safe treatment. We are continuing to explore the efficacy of nVNS in a range of related diseases and disorders.”

Notes to Editors:

• electroCore LLC was founded in 2005 and is based in New Jersey, USA.
• The gammaCore therapy for cluster headache is currently being launched through specialist headache specialists in Canada, Germany, UK, with US approval anticipated in 2015.
• In Europe, electroCore’s nVNS technology has a CE mark for primary headache, bronchoconstriction, epilepsy, gastric motility disorders, and anxiety and depression. It also has regulatory approval for the acute and/or prophylactic treatment of cluster headache, migraine and medication overuse headache in South Africa, India, New Zealand, Australia, Colombia, Brazil and Malaysia, and in Canada for cluster headache.
• electroCore’s gammaCore device is approved for the treatment of multiple conditions in neurology, psychiatry, respiratory, and other fields. Initial focus is on primary headache (migraine and cluster headache), with trials continuing in gastric motility disorders and epilepsy.
• The three poster presentations are available at http://ecorelibrary.com
• www.electrocorellc.com
  
  

  ¹ European Headache and Migraine Trust International Congress- EHMTIC

  ² Cluster headaches are acknowledged to be the most painful type of headache, worse even than severe migraines. In fact, experts have suggested that cluster headache may be the most painful condition known to medical science . NHS Choices

  ³ The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems

  ⁴ HIT is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home and in social situations. Your score shows you the effect that headaches have on normal daily life and your ability to function. HIT was developed by an international team of headache experts from neurology and primary care medicine in collaboration with the psychometricians who developed the SF-36® health assessment tool.

Contact:

Vane Percy & Roberts for electroCore LLC
Simon Vane Percy
(T) +44-(0)-1737-821890
(e) simon@vanepercy.com

Link:

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