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Submitted by PatientsEngage on 8 February 2018
Image of Vagus Nerve Stimulator Gammacore on the neck of a person to help with Migraine Pain

ElectroCore, LLC (electroCore), a commercial-stage bioelectronic medicine company 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 follows the initial FDA clearnance receieved by gammaCore for the acute treatment of pain associated with episodic cluster headache in adult patients in April 2017.

"Migraine is a debilitating disease affecting 39 million Americans, the majority of whom do not seek medical care for their pain.1 With the FDA's decision to release gammaCore for migraine, patients now have access to an effective and safe therapy which can be self-administered to acutely treat the pain associated with migraine," said Stephen D. Silberstein, M.D., Professor of Neurology and Director of the Headache Center, Thomas Jefferson University.

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).2 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.2 The results further showed that a significantly higher proportion of gammaCore-treated patients achieved pain relief within two hours compared with the control treatment.2 Consistent with all prior studies with gammaCore, the therapy was found to be well tolerated by patients.2

The device will be available commercially for the treatment of migraine headache pain in adults in the second quarter of 2018, according to the manufacturer. gammaCore is available by prescription only. U.S. Federal Law restricts this device to sale by or on the order of a licensed healthcare provider. 

It adds, though, that the safety and effectiveness of the prescription-only device have not been established in the acute treatment of chronic cluster headache or in the prophylactic treatment of chronic or episodic cluster or migraine headache.

This type of therapy is also not indicated for children; pregnant women; patients with active implantable medical devices; those with conditions such as carotid atherosclerosis, hypertension, or bradycardia/tachycardia;  or those with a metallic device, such as a stent, bone plate, or bone screw near the neck. It also shouldn't be used at the same time as the use of a mobile phone or other portable electronic device.

Results from PRESTO found that acute treatment with gammaCore was superior to sham for pain freedom at 30, 60, and 120 minutes after use. In the PRESTO study, as with previous studies, gammaCore was well-tolerated with a low incidence of adverse effects. The full results:

12.7% of patients who used gammaCore were pain-free after 30 minutes (compared to 4.2% control)
21% were pain-free after 60 minutes (compared to 10% in the control)
30% were pain-free after 120 minutes (compared to 19.7% control)*
41% had mild or no pain after 120 minutes (compared to 27.6% control)
*[Not statistically significant. The test was repeated to determine why the findings were not consistent at 120 minutes with the 30- and 60-minute findings. This second test confirmed that gammaCore was superior to the sham treatment after 120 minutes of use.]

About Migraine

Migraine is a term used to describe a class of recurrent, pulsing headaches that are typically unilateral (on one side of the head) but may occur bilaterally (on both sides of the head) and may cause visual disturbances, nausea and vomiting. They may occur with or without recognized warning signs, including either prodromal symptoms or an aura phase. Prodromal symptoms consist of altered mood, irritability, depression or euphoria, fatigue, dizziness and other visceral symptoms preceding the headache by several hours or days. Auras can include visual disturbances such as photopsia or scotomas or, in less frequent cases, somatosensory, auditory or gustatory hallucinations.3

Click here to understand more about Migraine - the symptoms, the triggers and management.

For more details on GammaCore read the press release:

https://www.prnewswire.com/news-releases/gammacore-receives-fda-clearan…

Reference

1 Migraine facts. Migraine Research Foundation. http://migraineresearchfoundation.org/about-migraine/migraine-facts. Accessed January 2018.

2 Tassorelli, C., (September 2017). Non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: a randomized controlled trial. Oral presentation at the Congress of the International Headache Society, Vancouver, Canada.

3 Migraine and aura. American Migraine Foundation. https://americanmigrainefoundation.org/understanding-migraine/migraine-…. Accessed January 2018.

4 Global burden of migraine in the Year 2000: summary of methods and data sources. World Health Organization. http://www.who.int/healthinfo/statistics/bod_migraine.pdf. Accessed January 2018.

SOURCE electroCore LLC

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