FDA Clears NRX-101: Investigational Drug for Complicated UTIs by NRx

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, has announced a significant milestone with the FDA’s clearance of its Investigational New Drug Application (IND) for NRX-101.

This patented combination of D-cycloserine and lurasidone is poised to address the urgent need for innovative treatments in Complicated Urinary Tract Infections (cUTI).

Key Points:

FDA Clearance: NRx Pharmaceuticals has received the coveted “Study May Proceed” letter from the FDA, allowing the company to advance its investigational drug NRX-101 for the treatment of cUTI.

Market Potential: Complicated Urinary Tract Infections affect approximately 3 million Americans annually, with increasing pathogen resistance to common antibiotics. NRX-101 aims to fill this critical treatment gap.

Novel Combination: NRX-101’s unique combination of D-cycloserine and lurasidone is a patented discovery by NRx Pharmaceuticals. The innovative blend addresses CNS side effects, making it a vital antibiotic when facing rising challenges in antibiotic resistance.

Personal Mission: Jonathan Javitt, MD MPH, Founder and Chief Scientist of NRx Pharmaceuticals, emphasizes the personal significance of the mission, having lost close friends to sepsis from urinary infections that were previously manageable.

Spinning Out a New Company: Recognizing the value of NRX-101, NRx Pharmaceuticals plans to spin out a new company dedicated to its development and commercialization for cUTI. With completed manufacturing, patent protection, and commercial-grade drug product availability, this initiative is expected to move swiftly.

Key Clinical Advisor: NRx has enlisted Michael Manyak, MD, an internationally recognized urologist, as the Lead Clinical Advisor for this initiative. Dr. Manyak brings extensive experience, having served in various leadership roles in medical affairs.

Next Steps: NRx awaits the FDA’s response to its request for Qualified Infectious Disease Product (QIDP) designation, with expectations for a decision next month.

About NRx Pharmaceuticals

NRx Pharmaceuticals focuses on developing therapeutics based on its NMDA platform for central nervous system disorders. NRX-101, the FDA-designated investigational Breakthrough Therapy, has potential applications in suicidal treatment-resistant bipolar depression and chronic pain. NRx Pharmaceuticals aims to address critical medical needs with its innovative drug candidates.

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements, and readers are advised to consider the inherent risks and uncertainties. NRx Pharmaceuticals assumes no obligation to revise forward-looking statements based on new information or future events.

SOURCE NRx Pharmaceuticals, Inc.

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