January 14, 2022
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FDA grants breakthrough designation for device to treat PTSD

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The FDA has granted breakthrough device designation to electroCore Inc. for its gammaCore device to be used in the treatment of PTSD in military personnel, according to a company release.

“We appreciate the thorough and timely review by the FDA of our Breakthrough Device Request for gammaCore for the treatment of PTSD,” said Eric Liebler, senior vice president of neurology at electroCore. “The ability of (non-invasive vagus nerve stimulation [nVNS]) to target several of the underlying causes of PTSD such as autonomic dysfunction, stress and inflammation, safely and effectively supports its potential as a breakthrough treatment for PTSD.”

The portable device is a noninvasive, hand-held therapy. When applied at the neck, it treats migraine and cluster headaches through deliverance of mild electrical stimulation to the vagus nerve, which can lead to pain reduction. GammaCore can be self-administered by patients, as needed, without possible side effects from commonly prescribed drugs.

The breakthrough device designation was supported by research conducted by a joint effort between physicians from Emory University and Georgia Tech, led by J. Douglas Bremner, MD and Omer T. Inan, PhD. Their study demonstrated how nVNS blocks sympathetic and inflammatory responses to memories of traumatic events in patients with PTSD, modulates brain responses to traumatic memory and reduced symptoms by 31% compared with a sham stimulation.

“Current treatments for PTSD involving medication and psychotherapy have limitations due to limited efficacy, possible side effects and the unwillingness of many PTSD patients to engage in therapies that involve reliving traumatic memories,” Bremner said in the release.

“GammaCore represents a new class of treatment separate from medication or psychotherapy that is safe, relatively free of side effects, and does not involve costly and invasive procedures for implantation, like previous VNS devices approved by the FDA for treatment of refractory depression.”

GammaCore had been previously cleared by the FDA for auxiliary use to prevent cluster headache in adults, for acute treatment of pain resulting from episodic cluster headache in adults, as well as for acute and preventive treatment of migraines in patients aged 12 or above.