ElectroCore LLC Receives FDA Clearance for the Acute Treatment of Pain Associated with Migraine Headache in Adult Patients
January 29, 2018 at 08:45 am EST
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electroCore, LLC announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an expanded label for gammaCore® (nVNS) as an acute treatment of pain associated with migraine in adult patients. gammaCore therapy is a proprietary, non-invasive neuromodulation treatment delivered by a hand-held unit that stimulates the vagus nerve through the skin. This label expansion is the first for electroCore since gammaCore received its initial FDA clearance for the acute treatment of pain associated with episodic cluster headache in adult patients in April 2017. The FDA clearance of gammaCore for the acute treatment of pain associated with migraine was principally supported by the results of the multicenter, randomized, double-blind, sham-controlled trial, PRESTO (PRospectivE Study of nVNS for the Acute Treatment Of Migraine). Results from this trial, which were recently profiled at the Congress of the International Headache Society (IHC) in Vancouver in September 2017, demonstrated that treatment with gammaCore for the acute treatment of pain associated with migraine was superior to sham, and also enabled patients to reach pain freedom more frequently by 30, 60, and 120 minutes compared with sham treatment. The results further showed that a significantly higher proportion of gammaCore-treated patients achieved pain relief within two hours compared with the control treatment. Consistent with all prior studies with gammaCore, the therapy was found to be well tolerated by patients. gammaCore is also available outside of the U.S., including in Canada and the European Economic Area. In the U.S., gammaCore is commercially available for the acute treatment of pain associated with episodic cluster
headache in adults. electroCore expects commercial availability of gammaCore for the acute treatment of pain
associated with migraine headache in adults in the second quarter of 2018.
electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company. It provides non-invasive vagus nerve stimulation (nVNS) technology platform. The Companyâs product categories include Handheld, personal use medical devices for the management and treatment of certain medical conditions such as primary headache, and Handheld, personal use consumer products utilizing nVNS technology to promote general wellness and human performance. Its products include gammaCore, Truvaga and TAC-STIM. Its gammaCore Sapphire, is a prescription medical device that is used for a variety of primary headache conditions. Its Truvaga is a personal use consumer electronics general wellness product that does not require a prescription and is available direct-to-consumer from electroCore at www.truvaga.com. The Companyâs TAC-STIM product is not a medical device and is not intended to diagnose, cure, mitigate, prevent, or treat a disease or condition.