- 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…
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://ibn.fm/NRXP
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