ElectroCore Announces Two New Studies and a Publication
Increasing support of the practical utility of non-invasive Vagus nerve stimulation in adults
BASKING RIDGE, N.J., Jan. 08, 2019 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced two clinical studies focused on expanding the use of non-invasive vagus nerve stimulation (nVNS) for the acute and preventive treatment of migraine, and a recent publication of a real-world retrospective analysis which supports the use of nVNS as an effective therapeutic option for patients with cluster headache.
“We are committed to expanding our knowledge of the utility of nVNS for the treatment of primary headache disorders. Through the published paper which supports the real-world effectiveness of gammaCore in cluster headache, and the initiation of two important new trials in migraine, we are continually deepening our understanding of the ability of nVNS to address unmet needs among migraine and cluster headache patients,” said Peter S. Staats, M.D., Chief Medical Officer, electroCore.
Clinical developments featuring nVNS in migraine and cluster headache include:
- nVNS for the treatment of cluster headache: early UK clinical experience
This real-world retrospective analysis, published in theJournal of Headache and Pain examined data in chronic and episodic cluster headache patients (n=29 and n=1, respectively) who did not respond to or were intolerant of multiple preventive and/or acute treatments. Patients analyzed over an average of three to six months experienced a decrease in the frequency of cluster headache attacks, from 26.6 attacks per week to 9.5 attacks per week following initiation of nVNS, a mean difference of 17.1 (p<0.01). Average cluster headache attack duration decreased from 51.9 minutes to 29.4 minutes following the initiation of nVNS, a mean difference of 22.5 (p<0.01), and average cluster headache attack severity (rated on a 10-point scale) decreased from 7.8 to 6.0, a mean difference of 1.8 (p<0.01). Adverse events were mild and transient, and consistent with previous studies.
These results extend the findings of registration trials of nVNS in cluster headache patients including the PREVA (PREVention and Acute treatment of chronic cluster headache) pivotal study, a prospective, open-label, controlled, randomized clinical trial that demonstrated the safety and effectiveness of gammaCore as an adjunctive therapy for the preventive treatment of cluster headache.
- Initiation and first patient enrolled in the PREMIUM II study in the United States
PREMIUM II, a multicenter, prospective, double-blind, randomized, sham-controlled study, will evaluate the efficacy and safety of nVNS for the preventive treatment of migraine. The study will enroll up to 500 patients in 35 sites in the United States, with an anticipated duration of 18 months.
- Real-world study on the practical utility of gammaCore in the treatment of patients in migraine, consistent with the PREVA study
This study will be initiated in the EU shortly, to support the role of nVNS for the prevention or treatment of migraine compared with the patient’s current therapy.
gammaCore™ (nVNS) is a non-invasive, hand-held medical therapy FDA-cleared as an adjunctive therapy for the preventative treatment of cluster headache and as an acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients. 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 leading to a modulation of neurotransmitters and a reduction in pain.
gammaCore is the only therapy FDA cleared for the prevention of cluster headache.
gammaCore is available by prescription only and patients should speak with their doctor about whether gammaCore is right for them.
gammaCore SapphireTM (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated 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.
- The acute treatment of pain associated with migraine headache in adult patients.
- The safety and effectiveness of gammaCore (nVNS) have not been established in the acute treatment of chronic cluster headache
- gammaCore has not been shown to be effective for the preventive treatment of migraine headache
- The long-term effects of the chronic use of gammaCore have not been evaluated
- Safety and efficacy of gammaCore have not been evaluated in the following patients, and therefore it is NOT indicated for:
o Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
o Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
o Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
o Pediatric patients
o Pregnant women
o Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
- Patients should not use gammaCore if they:
o Have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck
o 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 of the important warnings and precautions before using or prescribing this product.
About Cluster Headache
Cluster headache is a series of relatively short but extremely painful headaches that has been described by patients and physicians as one of the most painful conditions in medicine. The suicide rate among these patients is 20 times the U.S. national average, leading to the condition being referred to as the “suicide headache.” There are approximately 350,000 cluster headache sufferers in the United States, approximately 225,000 of whom seek treatment each year primarily from the same headache specialists who treat migraine.
Migraine is a term used to describe a class of recurrent, pulsing headaches that are typically unilateral (on one side of the head) but may occur bilaterally (on both sides of the head) and may cause visual disturbances, nausea and vomiting. They may occur with or without recognized warning signs, including either prodromal symptoms or an aura phase. Prodromal symptoms consist of altered mood, irritability, depression or euphoria, fatigue, dizziness and other visceral symptoms preceding the headache by several hours or days. Auras can include visual disturbances such as photopsia or scotomas or, in less frequent cases, somatosensory, auditory or gustatory hallucinations.
There are approximately 39 million Americans living with migraine, and more than 100,000 migraines occur every day in the U.S. Migraine prevalence is significantly higher in females than in males, at a ratio of 3:1.
About electroCore, Inc.
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 preventative treatment of cluster headache and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
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.