Preservative-free formulation of ketamine, NRX-100, Granted FDA Fast-Track Designation for Suicidal Ideation in Patients with Depression, including Bipolar Depression
NRx Pharmaceuticals, Inc.
"NRx will be submitting patient-level data from controlled clinical trials that demonstrate ketamine to be superior to both a placebo and an active comparator, as well as either non-inferior or superior to electroshock therapy in treating various forms of depression, including patients with active suicidal ideation. Although ketamine in various forms is increasingly used to treat depression and related disorders, it is currently only approved by FDA only for use as an anesthetic and, therefore, not reimbursed by most insurance carriers for treatment of suicidality or depression. Intravenous ketamine is reimbursed by the Department of Veterans Affairs and the Department of Defense for its beneficiaries. By applying for FDA labeling for NRX-100 to treat suicidal depression, the Company hopes to make this potentially life-saving therapy available to all Americans, not just those who are able to pay out of pocket."
