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NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation of NRX-101 in Complicated Urinary Tract Infection and Pyelonephritis
NRX-101 has demonstrated potent activity against resistant urinary pathogens upon FDA reviewQIDP designation grants Priority Review and an additional 5 years
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"NRX-101 has demonstrated potent activity against resistant urinary pathogens upon FDA reviewQIDP designation grants Priority Review and an additional 5 years of additional product exclusivity 3 million Americans develop complicated Urinary Tract Infection (cUTI) each year at a cost that ranges from $4497 to $17,431 with a high rate of antibiotic resistance and need for inpatient hospitalization1Unlike many advanced-generation antibiotics, NRX-101 is not contra-indicated in sulfa and penicillin allergic patients and is not believed to disrupt the normal intestinal microbiome, potentially leading to reduced risk of C. difficile infectionData have been accepted for posting on biorxiv and are under review at a peer-reviewed journal3RADNOR, Pa., Jan. 16, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (\"NRx Pharmaceuticals\", the \"Company\"), a clinical-stage biopharmaceutical company, today announced that it has received Qualified Infectious Disease Product (QIDP) and Fast Track designation from the US FDA for NRX-101 in the treatment of complicated urinary tract infections (cUTI) and pyelonephritis. Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101's already strong Intellectual Property position. The FDA also granted NRX-101 Fast Track designation for cUTI, which additionally allows for rolling submission of the Company's New Drug Application. In addition to the marketplace protections conferred by QIDP designation in the US, NRx has composition of matter patent protection on NRX-101 through at least 2033 in all major global markets. The data that formed the basis of FDA's QIDP approval have been submitted for publication. On the basis of this advance, NRx is seeking partners with active involvement in urology, infectious disease and/or women's health for commercialization of NRX-101.\n\n \n \n \n \n \n \n\n \nThe active antibiotic ingredient of NRX-101 is D-cycloserine (DCS) that was developed as an antibiotic in the 1950's and used worldwide for the treatment of tuberculosis. However, it fell out of favor with the development of trimethoprim/sulfa and various penicillins, cephalosporins, and tetracyclines, in part because of the CNS effects associated with DCS-induced blockade of the brain's NMDA receptor. In the course of its CNS research, NR...