RADNOR, PA — In a significant development that could revolutionize the treatment of complicated urinary tract infections (cUTI) and pyelonephritis, NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has received Qualified Infectious Disease Product (QIDP) and Fast Track designation from the US FDA for its drug, NRX-101.
The QIDP designation not only confers Priority Review but also provides an additional five years of data exclusivity to NRX-101’s existing robust intellectual property position. The Fast Track designation further allows for the rolling submission of the company’s New Drug Application, thereby potentially accelerating the drug’s approval process.
NRX-101’s active antibiotic ingredient is D-cycloserine (DCS), initially developed as a tuberculosis treatment in the 1950s. Despite falling out of favor due to CNS effects linked with DCS-induced blockade of the brain’s NMDA receptor, NRx has found that small doses of lurasidone can counteract these effects, thus potentially extending DCS’s therapeutic life as an antibiotic.
The rising resistance to standard UTI treatments has left millions of Americans suffering from cUTI, necessitating increasingly toxic antibiotics and frequent intravenous therapy. However, DCS’s unique properties—being highly concentrated and unmetabolized in the urine upon oral administration—suggest it could effectively treat cUTI, thereby reducing the need for intravenous and inpatient treatments.
Further, NRx believes that due to DCS’s rapid absorption and excretion in the urine, NRX-101 could minimally disrupt the intestinal microbiome, which may help prevent secondary Clostridium difficile infection—a condition associated with doubled hospital mortality and costing the American healthcare system up to $1.6 billion annually.
The data that formed the basis of the FDA’s QIDP approval have been submitted for publication and are under review by a peer-reviewed journal. In light of this development, NRx is seeking partners for the commercialization of NRX-101, specifically those with active involvement in urology, infectious disease, and women’s health.
This FDA designation is a critical milestone for NRx Pharmaceuticals and could potentially herald a new era in the treatment of cUTI and pyelonephritis. For the biopharmaceutical industry, it signals the potential for older drugs to find new therapeutic applications, paving the way for innovative approaches to tackling antibiotic resistance—a pressing issue in modern healthcare.
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