FDA OKs electroCore’s gammaCore to Prevent Migraines

electroCore Inc., a commercial-stage bioelectronic medicine company, has received Section 510(k) clearance from the U.S. Food and Drug Administration (FDA) of the company’s submission seeking to expand the label indication of its gammaCore therapy to include the prevention of migraine in adult patients. 
 
“We are grateful to the FDA for clearing the expanded use of our novel gammaCore vagus nerve stimulation device into the prevention of migraine headache in adults who frequently suffer from this incapacitating condition,” stated Peter Staats M.D., chief medical officer of electroCore. “The American Migraine Foundation estimates that there are nearly 36 million adults in the United States suffering from migraine. gammaCore has been available for the acute treatment of migraine, and now can be used for prevention to more effectively treat these patients. This milestone is clearly a very meaningful expansion of our label indication within our total addressable market.”   
 
In addition to migraine prevention, gammaCore is currently indicated for adjunctive use for the preventive treatment of cluster headache and for the acute treatment of pain associated with episodic cluster headache and migraine headache in adult patients.