NRx Pharmaceuticals (NASDAQ: NRXP) Secures FDA Fast Track for IV Ketamine Formulation NRX-100 in Suicidal Depression Investor Brand Network

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 Administration (“FDA”) has granted Fast Track designation to its intravenous ketamine formulation, NRX-100, for the treatment of suicidal ideation in patients with depression, including bipolar depression (https://ibn.fm/LYPf7).

The new designation expands NRX-100’s potential patient population by tenfold compared to the FDA’s 2017 designation, which was limited to use in combination with NRX-101 for suicidal bipolar depression. This expansion also reflects the FDA’s determination that NRX-100 has the potential to address an…