Biopharmaceutical company NRx Pharmaceuticals Inc (NASDAQ: NRXP) declared on Monday that it has received FDA Fast Track designation for NRX-100, its preservative-free intravenous ketamine, to treat suicidal ideation in patients with depression, including bipolar depression. This expands the eligible patient population tenfold compared to the drug's 2017 designation, now addressing the estimated 13 million US adults who contemplate suicide annually.

The FDA decision recognizes NRX-100's potential to meet an unmet medical need, making it eligible for the Commissioner's National Priority Voucher (CNPV) and Accelerated Approval programs. Clinical trial data submitted to the FDA showed statistically significant reductions in suicidal ideation versus placebo and active comparators, with some studies reporting full remission within three days.

NRX-100 is the first preservative-free ketamine submitted to the FDA, avoiding the toxic benzethonium chloride found in most current formulations. NRx has established US-based, high-volume manufacturing and is pursuing FDA labeling to expand access beyond current Department of Veterans Affairs and Department of Defense coverage.

Fast Track status provides NRx with enhanced FDA engagement, rolling review eligibility, and potential priority review. The company is preparing to submit patient-level trial data and draft labeling as part of its CNPV application, targeting the USD3bn US suicidal depression market.