ElectroCore’s gammaCore (nVNS) Receives FDA’s 510(k) Approval, a Novel Therapy for Cluster Headache in Adults

ElectroCore’s gammaCore (nVNS) Receives FDA’s 510(k) Approval, a Novel Therapy for Cluster Headache in Adults

Shots:

  • The approval is supported by PREVA (PREVention and Acute treatment of chronic cluster headache) and Real World retrospective study assessing its gammaCore + SoC vs SoC alone evaluating safety & efficacy with its daily clinical use in adults with cluster headache
  • Results: reduction in cluster attacks per week (-5.9 vs -2.1); mean therapeutic gain in attacks per week 3.9, weekly reduction 50% vs 8.3%, 57% decrease in frequency of abortive medication; safe and well- tolerated
  • gammaCore (nVNS) is a bid self-administered non-invasive novel adjunctive therapy with mild electrical stimulation applied at the vagus nerve (neck portion), to prevent cluster and migraine headache in adult patients

Click here to read full press release/ article | Ref: ElectroCore | Image: electroCore