NRx Advances Safer Preservative-Free Ketamine Therapies for Depression

NRx Pharmaceuticals (NASDAQ: NRXP) is making significant strides in developing safer ketamine-based therapies, with the company recently refiling an Abbreviated New Drug Application (ANDA) for KETAFREE™, a preservative-free intravenous ketamine formulation. This development follows the U.S. Food and Drug Administration's approval of NRx's Suitability Petition to eliminate benzethonium chloride (BZT), a chemical preservative associated with cytotoxic and neurotoxic effects that is no longer considered Generally Recognized as Safe and Effective for pharmaceutical use. The European Medicines Agency has already discouraged BZT's use in injectable drugs, and the FDA previously removed it from topical antiseptics and hand cleansers over safety concerns, making NRx's preservative-free approach particularly timely and important for patient safety.

The company is pursuing dual regulatory pathways, with KETAFREE™ targeting all currently approved ketamine indications through the ANDA process, while simultaneously advancing NRX-100 under a New Drug Application (NDA) specifically for treating suicidal depression, including bipolar depression. NRX-100 has received Fast Track Designation from the FDA, positioning it for potential expedited review. This strategic approach allows NRx to address both immediate market needs through KETAFREE™ while developing specialized treatments for severe mental health conditions through NRX-100. The timing is crucial as healthcare providers face supply constraints and rising demand for ketamine therapies, making NRx's safer formulations particularly valuable for both hospital and outpatient use settings.

Beyond these developments, NRx Pharmaceuticals continues to advance its broader NMDA platform for central nervous system disorders, including NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. The company plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia, while also exploring its potential as a non-opioid treatment for chronic pain and complicated UTI. The full details of NRx's comprehensive approach to ketamine therapy development can be viewed through the InvestorBrandNetwork website, which provides additional context about the company's regulatory progress and therapeutic pipeline.