"NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced the filing of a patent application for NRX-100, its preservative-free intravenous ketamine formulation for the treatment of suicidal depression. The application discloses pharmaceutical compositions, methods of treatment and methods of manufacture and currently includes twenty claims. While subject to the patent review process of the US Patent and Trademark Office, if granted, the patent would provide NRX-100 exclusivity into 2045.
NRX-100 is specifically formulated without benzethonium chloride or other preservatives, which have been associated with cytotoxic or neurotoxic effects. Current governmental leadership has expressed strong interest in delivering medications without unnecessary or unproven preservatives. Demonstration of room temperature shelf stability in the absence of toxic excipients represents a novel pharmaceutical composition that has the potential to be listed in the FDA Orange Book. This patent filing builds on the company's recently initiated filing of an NDA for NRX-100 and its prior Fast Track Designation, with NRX-101, from the FDA. If granted, the patent will help protect the innovation behind this formulation as NRx advances its commercialization strategy.
""We are committed to delivering safer, more effective treatments for patients with suicidal depression,"" said Jonathan Javitt MD MPH, CEO of NRx Pharmaceuticals. "NRX-100 eliminates the need for benzethonium chloride, a compound with well-documented safety concerns, and reflects our belief that patients in crisis deserve therapies formulated with their long-term well-being in mind. With the recent FDA fee waiver now in place, we remain on track to complete our NDA submission this quarter — a critical step toward bringing this innovation to patients in need.""
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD.