NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Secures FDA Fast Track for IV Ketamine Formulation NRX-100 in Suicidal Depression
The FDA designation expands the drug’s potential patient pool tenfold, to an estimated 13 million Americans who consider suicide annually. Clinical trials demonstrated rapid and statistically significant reductions in suicidal ideation with IV ketamine versus placebo and comparators. Fast Track status makes NRX-100 eligible for Accelerated Approval and the Commissioner's National Priority Voucher program. NRx is preparing an expanded access policy and seeking meetings with FDA leadership to align on data submission. The U.S. suicidal depression market is estimated at more than $3 billion annually. NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug…
