gammaCore nVNS Gains Breakthrough Status for PTSD

Bioelectronic medicine company electroCore has received U.S. Food and Drug Administration (FDA) Breakthrough Designation for its gammaCore VNS device to treat post-traumatic stress disorder (PTSD). The designation comes after a 31 percent reduction of symptoms was shown compared to sham.
 
According to the U.S. Department of Veterans Affairs National Center for PTSD, about 15 million U.S. adults experience PTSD each year. In the Military and Veterans Administration alone, PTSD is reported to affect between 10-20 percent of veterans who served in each Operations Iraqi Freedom (OIF) and Enduring Freedom (OEF), the Gulf War (Desert Storm), and the Vietnam War.
 
Research showed nVNS blocks sympathetic and inflammatory responses to PTSD patients’ memories of traumatic events and modulates brain responses to traumatic memory as well.
 
“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,” J. Douglas Bremner, M.D., leader of the Emory-Georgia Tech research team evaluating gammaCore, told the press. “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.”
 
“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.”