NRx Pharmaceuticals has filed a patent application for NRX-100, a preservative-free intravenous ketamine formulation designed to treat suicidal depression. The patent filing, which includes 20 claims, could provide the company with potential market exclusivity through 2045 if granted.
The innovative formulation is specifically engineered without benzethonium chloride or other preservatives traditionally associated with toxicity. NRX-100 has demonstrated room temperature shelf stability, which may qualify it for FDA Orange Book listing—a significant milestone for pharmaceutical development.
This patent filing supports the company's New Drug Application (NDA) submission strategy and complements the existing FDA Fast Track Designation for its companion drug NRX-101. The development represents a potential advancement in treating central nervous system disorders, particularly suicidal depression.
The patent builds upon clinical trials conducted under the US National Institutes of Health and incorporates data from French health authorities. NRx was previously awarded Fast Track Designation by the FDA for ketamine's protocol in treating acute suicidality, underscoring the potential clinical significance of this formulation.
By developing a preservative-free ketamine treatment, NRx Pharmaceuticals aims to address existing limitations in current treatment approaches, potentially offering a safer and more effective option for patients struggling with suicidal depression.
