At the recent American Academy of Neurology meeting in Los Angeles, CA, electroCore, a commercial-stage bioelectronic medicine company, presented data from the PRESTO study of a hand-held noninvasive vagal nerve stimulation (VNS) therapy for acute treatment of pain associated with migraine and episodic cluster headache in adult patients.
Results from the level 1 PRESTO study led to Food and Drug Administration (FDA) approval of gammaCore for pain associated with migraine in adult patients in January 2018. The gammaCore neuromodulation device is also approved by the FDA for treatment of patients with episodic cluster headache.
PRESTO was a randomized, double-blind, sham-controlled, clinical trial in which 285 patients who were refractory to other migraine treatments were randomized to a treatment (n = 122) or sham control group (n = 126). Both groups had 5 subjects discontinue the study. After a first- treated migraine attack, with up to 3 stimulations over a 2-hour period, 30.4% of patients in the treatment group achieved freedom from pain versus 19.7% of patients in the sham group (P = .067)
This is the first FDA-cleared, noninvasive VNS administered via an easy-to-use handheld delivery system that requires no surgical intervention or procedure and no external power system. The gammaCore device can be prescribed by a physician and used by patients where ever they are, requiring only the device and the conducting gel that is applied to the skin prior to stimulation. The gammaCore provides patients with an effective option for acute treatment of pain associated with migraine and episodic cluster headache, without the potential side effects associated with commonly prescribed drugs for these conditions in a manner that may reduce cost to the healthcare system.
Peter Staats, MD, MBA, Chief Medical Officer of electroCore stated, “The beauty of the gammaCore is multifactorial. Not only does the noninvasive therapy have the efficacy of an implanted device, but it also lacks the cost or risks associated with surgical intervention and the patient and physician burden associated with injections and infusions. We have conducted level one pharmaceutical level studies with a completely novel approach, effectively using an electronic therapy to stimulate the vagus nerve. In a time when our country is in an opiate crisis, we have demonstrated a cost-effective alternative to currently available treatment strategies.”Next Story