NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Pursues Dual Pathway for Preservative-Free Ketamine-Based Therapies
The company has refiled its Abbreviated New Drug Application (“ANDA”) for KETAFREE(TM), a preservative-free IV ketamine formulation. The filing follows FDA approval of the company’s Suitability Petition to remove benzethonium chloride (“BZT”), a preservative linked to neurotoxicity. In parallel, NRx is advancing NRX-100, another preservative-free ketamine formulation under a New Drug Application (“NDA”) for suicidal ideation in depression, including bipolar depression. NRX-100 holds Fast Track Designation and may qualify for the FDA’s National Priority Voucher Program. The company also continues work on NRX-101, a Breakthrough Therapy for suicidal bipolar depression. CEO Dr. Jonathan Javitt recently discussed new pipeline developments and…
