The US Food and Drug Administration has asked for an expanded indication of the gammaCore device. The company has 180 days to respond.
electroCore (NASDAQ:ECOR) has announced that the US Food and Drug Administration (FDA) has requested more information regarding its premarket 510(k) submission for its gammaCore.
As quoted in the press release:
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 currently FDA-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 journal Cephalalgia (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.