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NRx Pharmaceuticals Announces FDA Clearance of its Investigational New Drug (IND) Application for NRX-101 in the Treatment of Complicated Urinary Tract Infections
"Study May Proceed" letter received from FDAPotential to initiate registrational study in 2024RADNOR, Pa., Dec. 18, 2023 /PRNewswire/ -- NRx Pharmaceuticals,
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"\"Study May Proceed\" letter received from FDAPotential to initiate registrational study in 2024RADNOR, Pa., Dec. 18, 2023 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (\"NRx Pharmaceuticals\", the \"Company\"), a clinical-stage biopharmaceutical company today announced that its Investigational New Drug Application (IND) for the use of NRX-101, the company's patented combination of D-cycloserine and lurasidone, for the treatment of complicated Urinary Tract infections (cUTI), received clearance from the US FDA.\n\n \n \n \n \n \n \n\n \n\"Complicated Urinary Tract Infections afflict approximately 3 million Americans each year, and pathogens have become increasingly resistant to commonly used antibiotics. New treatment options are urgently needed\" stated Jonathan Javitt, MD MPH, Founder and Chief Scientist of NRx Pharmaceuticals. \"The D-cycloserine (DCS) component of NRX-101 is well known as an antibiotic and is excreted unmetabolized in the urine. However, the NMDA-antagonist effects of DCS led to its disuse in the United States, while it has remained a widely used anti-tuberculosis agent by the World Health Organization. NRx's patented discovery that combining DCS with small amounts of lurasidone counters the CNS side effects potentially and renders NRX-101 an important, patented antibiotic, just at a time when Americans are increasingly facing intravenous antibiotic therapy and even hospitalization and death from pathogens that were readily controlled a generation ago. This mission is personal to me, in that I have lost two close friends, one the father of a founding investor, to sepsis from urinary infections that were readily controlled a generation ago.\"\nAs previously disclosed, the company sees the greatest value for this program in an independent company dedicated to the development and commercialization of NRX-101 for cUTI. Because the manufacturing phase of NRX-101 is complete, the Company has secured Composition of Matter patent protection, and the Company has commercial-grade drug product on hand, this initiative is not expected to require additional investment in R&D prior to clinical trials. Accordingly, the company is developing plans to spin out a new company, much like the planned spin-out of Hope Therapeutics to develop NRX-100 (IV Ketamine) for suicidal depression, where NRx, existing shareholde...