electroCore, Inc., a commercial-stage bioelectronic medicine company, today announced that its gammaCoreTM nVNS device has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for the treatment of post-traumatic stress disorder after showing a reduction of symptoms of post-traumatic stress disorder (PTSD) by 31% when compared to sham.
The Breakthrough Device Designation was supported, in part, by research from an Emory University-Georgia Tech team led by J. Douglas Bremner and Omer Inan.
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that its gammaCoreTM nVNS device has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for the treatment of post-traumatic stress disorder after showing a reduction of symptoms of post-traumatic stress disorder (PTSD) by 31% when compared to sham.
PTSD is a highly prevalent and disabling disorder with limited approved treatment options. According to the U.S. Department of Veterans Affairs National Center for PTSD, approximately 15 million adults in the U.S. experience PTSD each year. In the Military and Veterans Administration (VA) alone, PTSD is reported to affect between 10-20% of veterans who served in each Operations Iraqi Freedom (OIF) and Enduring Freedom (OEF), the Gulf War (Desert Storm), and the Vietnam War.
More than half of all patients with PTSD report severely impaired quality of life in areas including mood, social and family relationships, leisure activities, sense of well-being and life satisfaction.
The Breakthrough Device Designation was supported, in part, by research from an Emory-Georgia Tech team led by J. Douglas Bremner, M.D., in the Departments of Psychiatry and Radiology at the Emory University School of Medicine, and Omer T. Inan, Ph.D, from the School of Electrical and Computer Engineering and the Coulter Department of Biomedical Engineering at the Georgia Institute of Technology in Atlanta, Georgia. Their research, built upon a strong mechanistic rationale and animal studies, shows nVNS blocks sympathetic and inflammatory responses to memories of traumatic events in patients with PTSD, modulates brain responses to traumatic memory, and reduces symptoms of PTSD by 31% when compared to a sham stimulation.
Dr. Douglas Bremner commented, “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. gammaCore represents a new class of treatment separate from medication or psychotherapy that is safe, relatively free of side effects, and doesn’t involve costly and invasive procedures for implantation, like previous VNS devices approved by the FDA for treatment of refractory depression.”
“We appreciate the thorough and timely review by the FDA of our Breakthrough Device Request for gammaCore for the treatment of PTSD,” commented Eric Liebler, senior vice president of Neurology at electroCore. “The ability of 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 Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to critical medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company's current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.
For more information, visit www.electrocore.com.
About gammaCoreTM
gammaCoreTM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.
gammaCore (nVNS) is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.