GammaCore Now Approved for Acute Migraine Treatment
Imagine putting a stop to your next Migraine attack with the push of a button. That dream is now possible with the U.S. Food and Drug Aministration approval of Gammacore - a non-invasive vagus nerve stimulator. It's not a pill, nasal spray, or injection. It doesn't require refrigeration and doesn't come wrapped in one of those impossible-to-open blister packs. It's a handheld device about the size of a cell phone that can be carried in a purse or a backpack.
Clinical study results
- 243 patients with episodic Migraine were enrolled.
- Some subjects were pain-free as early as 30 minutes following treatment.
- Pain-free results were demonstrated at 30, 60, 90, and 120 minutes.
- Over 40 percent of subjects were pain-free within two hours.
About the vagus nerve
- The lining of gastrointestinal tract is the largest vulnerable body surface exposed to the environment.
- It has direct communication with the central nervous system through the vagus nerve.
- The vagus nerve connects the enteric nervous system to the brain stem.
- The enteric nervous system (ENS) is commonly referred to as the "gut-brain."
- It includes the esophagus, stomach, large, and small intestines.
- The ENS is the only human organ system capable of independently functioning without the brain.
- The ENS contains more than 100 million neurons and 30 neurotransmitters.
- It produces 50 percent of the body's dopamine and over 95 percent of its serotonin.
- 90 percent of the signals traveling along the vagus nerve are sent from the ENS to the brain stem.
- Vagus-nerve stimulation can intercept, change, and mimic these signals.
Who should not use it?
GammaCore has not been approved for the prevention of Migraine or for use during pregnancy or by children under age 18.
It should not be used in those who have:
- Implanted medical devices
- Narrowing of arteries
- Prior surgery to the vagus nerve
- Uncontrolled hypertension
- History of cardiovascular disease
- Abnormal baseline ECG
- History of seizures
These side effects, when present, resolved upon treatment completion:
- Shortness of breath
- Hoarseness or voice change
- Muscle twitching, discomfort, or pain
- Change in taste
Other reported side effects include:
- Skin irritation
- Worsening of headache
- GammaCore is currently available by prescription for the acute treatment of cluster headache.
- It will be available by prescription for the acute treatment of Migraine in the second quarter of 2018.
- Insurance coverage varies. ElectroCore is working diligently to get GammaCore covered by as many insurance plans as possible.
- GammaCore is available as a monthly refill. Each device functions for 31 days and is replaced by a new device each month.
- It can be used daily to treat Migraine attacks without concern for medication overuse headache.
- More information is available on the GammaCore website.
See more helpful articles:
Hadhazy, A. Think Twice: How the Gut's "Second Brain" Influences Mood and Well-Being, Scientific American, 12 FEB 2010.
Powley, T, Phillips, R. I. Morphology and topography of vagal afferents innervating the GI tract. American Journal of Physiology-Gastrointestinal and Liver Physiology. 2002 283:6, G1217-G1225.
Young, E. Gut instincts: The secrets of your second brain, Neurosciencestuff.tumblr.com, 18 DEC 2012.