
electroCore Provides Update on 510(k) Submission Seeking Expanded Indication for gammaCore™
Additional information requested by FDA; Premium 2 trial progressing as planned
September 25, 2019 at 8:00am ET
BASKING RIDGE, N.J., September 25, 2019 — electroCore, Inc. (Nasdaq: ECOR, or the “Company”), a commercial-stage bioelectronic medicine company, today announced that the U.S. Food and Drug Administration (“FDA”) has requested more information and analysis of the clinical data included in the Company’s premarket notification, or “510(k)” submission, seeking an expanded indication for the use of gammaCore™(non-invasive vagus nerve stimulator). Although the Company has 180 days to respond to FDA’s request, the Company expects to meet with the FDA in the fourth quarter to discuss the information request. gammaCore™ is currentlyFDA-cleared for the treatment of pain associated with episodic cluster headache and migraine headache, and adjunctive use for the prevention of cluster headache.
The data submitted in the 510(k) include the results of the Premium 1 study, a randomized, double-blind, sham-controlled trial of gammaCore™ recently published in the journalCephalalgia (https://journals.sagepub.com/doi/pdf/10.1177/0333102419876920).
“We look forward to meeting soon with the FDA to discuss our 510(k) submission and are committed to working with the agency to address their questions as quickly as possible,” said Tony Fiorino, Chief Medical Officer of electroCore. “Meanwhile we continue to recruit subjects into the Premium 2 study which we anticipate will further define the clinical utility of gammaCore™ in the migraine space.”
Premium 2 Clinical Trial Update
Premium 2 is a randomized, double-blind, sham-controlled clinical trial of gammaCore™ for the prevention of migraine being conducted at approximately 30 sites in the United States (ClinicalTrials.gov identifier NCT03716505). Premium 2 was designed to support an expanded FDA clearance and the commercialization and reimbursement of gammaCore™ Currently, the enrollment in Premium 2 is nearing 50% of its target of approximately 400 subjects, and recruitment is expected to conclude in the first half of 2020.
About electroCore, Inc.
electroCore, Inc. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes through its platformnon-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.