ROCKAWAY, NJ, Jan. 10, 2022 (GLOBE NEWSWIRE) – electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a peer-reviewed article titled ” Non-invasive vagus nerve stimulation for migraine prevention: the multicenter, randomized, double-blind, simulation-controlled PREMIUM II trial Headache, the official journal of the International Headache Society (IHS). The article reports the results of a randomized, double-blind, simulation-controlled trial conducted at twenty-seven sites across the United States. Originally designed and powered to randomize 400 patients, the study was prematurely closed due to COVID-19 after recruiting 231 subjects.
The results of the study showed a decrease in the number of monthly headache days of 4.6 versus -3.0 for the dummy treatment (p = 0.05) with 44.87% of subjects in the gammaCore group having a reduction of more than 50% in the number of migraine days. per month against 26.81% for the simulated group (p = 0.05). The quality of life, measured by the HIT-6 (Headache Impact scale), improved by -4.9 points against -2.3 for the sham (p 100% compared to the simulacrum. These results are consistent with previous reports on mechanisms of action which suggest that nVNS may be particularly effective in patients with migraine with aura.
Dr Umer Najib, associate professor, program director of the Headache Medicine Fellowship Program at the University of West Virginia and first author of the article commented: “We are pleased to have added to the data which helps suggest the types migraine patients who could possibly get the most benefit from nVNS. The safety and tolerability of nVNS is such that it can be used as a stand-alone or add-on therapy, depending on the patient’s needs, and its flexibility allows healthcare providers to consider it for many of their patients.
“We congratulate and thank all the investigators, site staff and subjects who conducted this study across the United States despite the challenges that have arrived with COVID-19,” commented Eric Liebler, senior vice president of the United States. neurology at electroCore. “With seven different indications from the FDA, gammaCore is safe and effective for many patients with primary headache, and the results of this study highlighting potential benefits in patients with migraine with aura are particularly compelling. “
The full publication is available at: https://journals.sagepub.com/doi/10.1177/03331024211068813
About electroCore, Inc.
electroCore, Inc. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes with its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of several conditions in neurology. The current indications of the company are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and cluster headache episodic, the acute and preventive treatment of migraine in the adolescent and paroxysmal hemicrania and continuous hemicrania in adults.
For more information, visit www.electrocore.com.
gammaCoreMT (nVNS) is the first non-invasive portable medical treatment applied to the neck as an adjunct to treat migraine and cluster headaches of the face through the use of mild electrical stimulation of the vagus nerve that passes through the skin. Designed as portable and easy to use technology, gammaCore can be self-administered by patients as needed without the potential side effects associated with commonly prescribed medications. When placed on a patient’s neck above the vagus nerve, gammaCore stimulates the afferent fibers of the nerve, which can lead to reduced pain in patients.
gammaCore (nVNS) is cleared by the FDA in the United States for adjuvant 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 and preventive treatment of migraine in adolescents (aged 12 years and older) and adult patients, and paroxysmal hemicrania and continuous hemicrania in adult patients. gammaCore is CE marked in the European Union for the acute and / or prophylactic treatment of primary headache (migraines, cluster headache, trigeminal autonomic headache and continuous bleeding) and headache from drug abuse in adults.
gammaCore is contraindicated in patients if they:
- Have an active implantable medical device, such as a pacemaker, hearing aid implant, or other electronic device implanted
- Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
- Use another device at the same time (eg TENS unit, muscle stimulator) or any other portable electronic device (eg cell phone)
The safety and efficacy of gammaCore have not been evaluated in the following patients:
- Adolescent patients with congenital heart problems
- 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 (under 12 years old)
- Pregnant women
- Patients with clinically significant hypertension, hypotension, bradycardia or tachycardia
Please refer to the gammaCore Instructions for Use for all important warnings and precautions before using or prescribing this product.
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the activities of electroCore. prospects and plans for clinical and product development (including enrollment in ongoing studies); its pipeline or potential markets for its technologies; the timing, results and impact of regulatory, clinical and commercial developments; the issuance of US and international patents providing extended IP coverage; the possibility of future business models and revenue streams from the company’s potential to use nVNS for symptoms associated with migraine with aura, the potential of nVNS in general and gammaCore in particular and other statements that are not historical in nature, especially those which use terminology such as “anticipates”, “will”, “expects”, “believes”, “intends”, other words with similar meaning, derivations of these words and the use of future dates. Actual results could differ from those projected in the forward-looking statements due to many factors. These factors include, but are not limited to, the ability to raise the additional funds necessary to continue pursuing business plans. activity and product development of electroCore, the inherent uncertainties associated with the development of new products or technologies, the ability to commercialize gammaCore ™, the impact and effects s potentials of COVID-19 on electroCore’s business, results of operations and financial performance of electroCore, and any actions that electroCore has and may take in response to COVID-19 and any expectations that electroCore may have in this regard, competition in the industry in which electroCore operates and general market conditions. All forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update any forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements. , unless Required by law. Investors should review all information set forth in this document and should also refer to the risk factor disclosure set forth in reports and other documents filed by electroCore with the SEC available at www.sec.gov.