NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Patent Application for NRX-100, its Proprietary, Preservative Free Formulation of IV Ketamine
Rhea-AI Summary
NRx Pharmaceuticals (NASDAQ:NRXP) has filed a patent application for NRX-100, its preservative-free intravenous ketamine formulation designed to treat suicidal depression. The patent, if granted, would provide exclusivity until 2045 and could be listed in the FDA Orange Book. NRX-100's key innovation is its formulation without benzethonium chloride or other preservatives, which have been linked to cytotoxic or neurotoxic effects.
The company has already initiated an NDA filing for NRX-100 and received Fast Track Designation with NRX-101 from the FDA. With a recent FDA fee waiver in place, NRx plans to complete its NDA submission in the current quarter. The patent application includes twenty claims covering pharmaceutical compositions, treatment methods, and manufacturing processes.
Positive
- Patent, if granted, would provide market exclusivity until 2045
- Preservative-free formulation addresses safety concerns associated with benzethonium chloride
- FDA fee waiver received, reducing regulatory costs
- Fast Track Designation already obtained with NRX-101
- NDA submission on track for completion this quarter
Negative
- Patent approval not guaranteed
- Product still in clinical-stage, pending FDA approval
- Commercial success uncertain despite potential advantages
News Market Reaction
On the day this news was published, NRXP declined 1.17%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
- Patent expected to be Orange Book listable, if granted
- NRX-100, preservative free, IV ketamine, is designed to avoid potential toxicity concerns linked to benzethonium chloride, used in currently available formulations of ketamine
- Filing strengthens NRx's leadership in advancing safe and effective treatments for suicidal depression
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."
About NRx Pharmaceuticals, Inc.
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. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently initiated a New Drug Application filing for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com), a subsidiary of NRx Pharmaceuticals, is a Healthcare delivery company that is building a best-in-class network of interventional psychiatry clinics to offer ketamine, transcranial magnetics stimulation (TMS), and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
For further information: | |
Matthew Duffy | Brian Korb |
Co-CEO, Hope Therapeutics, Inc. | Managing Partner, ASTR Partners |
Chief Business Officer, NRx Pharmaceuticals, Inc. | (917) 653-5122 |
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SOURCE NRx Pharmaceuticals, Inc.
FAQ
What is NRX-100 and how is it different from current ketamine treatments?
When will NRXP's patent for NRX-100 expire if granted?
What is the current regulatory status of NRXP's NRX-100?
How many claims does NRXP's patent application for NRX-100 include?
Has NRXP received any FDA incentives for NRX-100 development?
