NRx Pharmaceuticals Gains FDA Approval for Preservative-Free Ketamine

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) announced the FDA's approval of its Suitability Petition, allowing the shift from multidose ketamine to a single-patient, preservative-free variant called KETAFREE™. This approval enables NRx to re-file its Abbreviated New Drug Application (ANDA) for this innovative product, which aligns with key policy objectives. These include re-shoring drug manufacturing and eliminating toxic preservatives from pharmaceuticals.

The ketamine market is valued at approximately $750 million, and NRx aims to inject its KETAFREE™ product into this arena. This development coincides with the company's broader mission to provide non-generic ketamine formulations, such as NRX-100, targeting conditions like suicidal depression and PTSD. CEO Jonathan C. Javitt expressed gratitude for the FDA's prompt response and optimism about KETAFREE™'s market introduction.