electroCore to Present Additional Research for Non-invasive Vagus Nerve Stimulation (nVNS) in Headache Disorders at the 60th Annual Meeting of the American Headache Society
BASKING RIDGE, N.J., June 28, 2018 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq:ECOR), a commercial-stage bioelectronic medicine company, announced today it will present six abstracts across three primary headache disorders at the 60th Annual Meeting of the American Headache Society (AHS) (June 28-July 1, 2018, San Francisco). Two additional pieces of independent, non-sponsored research featuring non-invasive vagus nerve stimulation (nVNS) will also be presented at the meeting. Presentations at the meeting will highlight new data that span migraine, chronic cluster headache and chronic paroxysmal hemicrania patient populations, as well as co-occurrences relating to functional disorders, such as primary headache.
“Together with our partners, electroCore is making significant discoveries surrounding the impact that non-invasive nerve stimulation can have as a therapy for primary headache disorders,” said Peter S. Staats, M.D., Chief Medical Officer, electroCore. “We look forward to sharing these data with the scientific and medical communities at AHS and are excited by the extent of discussion around nVNS at the meeting.”
Three posters will highlight data from the PRESTO clinical trial for gammaCore® (nVNS), which is currently indicated for the acute pain associated with migraine and episodic cluster headache. PRESTO was a prospective multi-center, randomized, double-blind, sham-controlled study of gammaCore for the acute treatment of migraine. The full PRESTO manuscript was recently published in the online issue of Neurology®, the medical journal of the American Academy of Neurology. The manuscript will appear in Neurology’s July 25 print issue.
The nVNS-related research to be presented at the 60th Annual AHS meeting includes:
- Oral Presentation:
- Non-invasive Stimulation of the Vagal Nerve Reduces Provoked Cranial Autonomic Output in Healthy Volunteers [#OR12, June 30, 2018, 11:00-11:10 a.m. PT, includes Q&A session] (independently researched)
- Poster Presentations(on display from 6:30 a.m.-5:00 p.m. PT in the Yerba Buena Ballroom):
- Headache Co-Occurrences with Function Disorders: Testing a Theory of Latent Causation [#PF121LB, June 29, 2018, 1:15-2:15 p.m. PT]
- Case Report: Chronic Paroxysmal Hemicrania Treated with External Vagal Nerve Stimulator (gammaCoreTM) [#PS04, June 30, 2018, 1:00-2:15 p.m. PT] (independently researched)
- Non-invasive Vagus Nerve Stimulation (nVNS) for the Acute Treatment of Migraine: The Multicenter, Double-blind, Randomized, Sham-controlled PRESTO Trial [#PS27, June 30, 2018, 1:00-2:15 p.m. PT]
- Evaluating the Benefits of More Frequent Non-invasive Vagus Nerve Stimulation (nVNS) for Patients With Chronic Cluster Headache: A Post Hoc Analysis of the PREVA Trial [#PS28, June 30, 2018, 1:00-2:15 p.m. PT]
- Practical and Clinical Utility of Non-invasive Vagus Nerve Stimulation (nVNS) for the Acute Treatment of Migraine: Post Hoc Assessment of the Randomized, Sham–Controlled, Double-blind PRESTO Trial [#PS33, June 30, 2018, 1:00-2:15 p.m. PT]
- Open-Label Findings From the Randomized Sham-Controlled PRESTO Study of Non-invasive Vagus Nerve Stimulation for the Acute Treatment of Episodic Migraine [#PS44, June 30, 2018, 1:00-2:15 p.m. PT]
- Comparison of Active and “Sham” Non-Invasive Vagal Nerve Stimulation on Lacrimation in Healthy Volunteers (independently researched and supported by an unrestricted research grant from electroCore) [#PS76, June 30, 2018, 1:00-2:15 p.m. PT]
gammaCore® (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck that acutely treats the pain associated with migraine and episodic cluster headache in adult patients through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. 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. gammaCore is currently available outside of the U.S., including in the European Economic Area, where it is CE-Marked.
The multicenter, randomized, double-blind, sham-controlled trial evaluated the efficacy, safety and tolerability of nVNS in 243 patients with episodic migraine. Results from PRESTO found that acute treatment with gammaCore was superior to sham for pain freedom at 30 minutes (12.7% vs 4.2%; p=0.012) and 60 minutes (21.0% vs 10.0%; p=0.023); however, the improvement at 120 minutes missed statistical significance (30.4% vs 19.7%; p=0.067). A post-hoc repeated-measures test was performed to examine the statistical anomaly between the 120-minute findings and the 30- and 60-minute findings. This test confirmed that gammaCore was superior to sham through 120 minutes (odds ratio: 2.3; 95% CI: 1.2, 4.4; p=0.012). Clinically meaningful and statistically significant benefits from our gammaCore therapy were also observed in the secondary endpoints pain relief at 120 minutes (40.8% vs 27.6%; p=0.030) and mean percent pain reduction at 120 minutes (34.8% vs 5.4%; p=0.004). gammaCore was well tolerated, as demonstrated by a low incidence of device-related adverse effects.1
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.
IMPORTANT SAFETY INFORMATION REGARDING GAMMACORE
- The safety and effectiveness of the gammaCore (nVNS) has not been established in the acute treatment of chronic cluster headache.
- gammaCore has not been shown to be effective for the prophylactic treatment of chronic or episodic cluster headache or migraine headache.
- The long-term effects of the chronic use of gammaCore have not been evaluated.
- Safety and efficacy of gammaCore has not been evaluated in the following patients, and therefore is NOT indicated for:
- 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)
Note: This list is not all inclusive. Please refer to the gammaCore Instructions for Use for all important warnings and precautions before using or prescribing this product.
gammaCore is available by prescription only. U.S. Federal Law restricts this device to sale by or on the order of a licensed healthcare provider.
1 Tassorelli, C et al., (June 2018). Non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: a randomized controlled trial. Neurology. http://n.neurology.org/content/early/2018/06/15/WNL.0000000000005857. Accessed June 2018.
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