NRx Pharmaceuticals Files Patent for Preservative-Free IV Ketamine Formula

NRx Pharmaceuticals, Inc., a clinical-stage biopharmaceutical organization, has announced the submission of a patent application for NRX-100, a preservative-free intravenous ketamine formulation intended to treat suicidal depression. This patent application outlines pharmaceutical compositions, treatment methods, and manufacturing processes, comprising twenty claims. If the patent is approved, it could secure exclusivity for NRX-100 until 2045.

NRX-100 is distinctively prepared without benzethonium chloride or other preservatives, which are known to have cytotoxic or neurotoxic effects. The removal of such preservatives aligns with government interest in providing treatments devoid of unnecessary or unverified additives. Demonstrating stability at room temperature without toxic excipients, NRX-100 represents a novel approach that could potentially be listed in the FDA's Orange Book. This patent application follows the recent filing of a New Drug Application (NDA) for NRX-100 and benefits from the earlier Fast Track Designation granted by the FDA for NRX-101.

Jonathan Javitt MD MPH, CEO of NRx Pharmaceuticals, emphasized the company's dedication to offering safer and more effective treatments for individuals with suicidal depression. NRX-100 eliminates benzethonium chloride, a compound associated with documented safety issues, underscoring NRx's commitment to patient safety. With the recent waiver of FDA fees, the company is poised to complete its NDA submission within the current quarter, marking a crucial step toward making this innovative treatment accessible to patients in need.

NRx Pharmaceuticals is focused on developing therapeutics rooted in its NMDA platform to address central nervous system disorders, particularly suicidal bipolar depression, chronic pain, and PTSD. The company's flagship product, NRX-101, has received FDA's Breakthrough Therapy designation for treating suicidal treatment-resistant bipolar depression and chronic pain. NRx aims to file for Accelerated Approval of NRX-101 for patients struggling with bipolar depression accompanied by suicidality or akathisia. Additionally, NRX-101 shows promise as a non-opioid option for managing chronic pain and as a treatment for complicated urinary tract infections.

Recently, NRx has initiated a New Drug Application filing for NRX-100 based on robust clinical trial data conducted in collaboration with the US National Institutes of Health and newly available information from French health authorities. The US FDA has awarded Fast Track Designation for the development of ketamine (NRX-100) as part of a protocol designed to treat patients experiencing acute suicidality.

HOPE Therapeutics, Inc., a subsidiary of NRx Pharmaceuticals, is establishing a premier network of interventional psychiatry clinics offering ketamine, transcranial magnetic stimulation (TMS), and other lifesaving therapies for patients contending with suicidal depression and similar conditions. Additionally, HOPE Therapeutics incorporates a digital therapeutic-enabled platform to enhance and maintain the clinical benefits of NMDA-targeted drug therapies.

In summary, NRx Pharmaceuticals' latest filing for NRX-100 aligns with its long-term strategy to deliver groundbreaking treatments for critical central nervous system disorders, with a focus on safety and patient well-being. By advancing NRX-100 and other key therapeutics, the company aims to address pressing mental health challenges and provide effective, well-tolerated solutions for individuals in need.