LOS ANGELES, CA - September 3, 2025 (NEWMEDIAWIRE) - 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 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.

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…

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Certain statements in this article are forward-looking, as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied by these forward-looking statements and may not be indicative of future results. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, various factors beyond management's control, including the risks set forth under the heading "Risk Factors" discussed under the caption "Item 1A. Risk Factors" in Part I of the Company's most recent Annual Report on Form 10-K or any updates discussed under the caption "Item 1A. Risk Factors" in Part II of the Company's Quarterly Reports on Form 10-Q and in the Company's other filings with the SEC. Undue reliance should not be placed on the forward-looking statements in this article in making an investment decision, which are based on information available to us on the date hereof. All parties undertake no duty to update this information unless required by law.

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