NRx Pharmaceuticals, Inc. (NASDAQ:NRXP), a biopharmaceutical company that focuses on neuroplastic therapies for depression, PTSD, and related conditions, today announces initiation of a first commercial manufacturing order of its preservative free ketamine product in anticipation of approval under the Generic Drug User Fee Act in Summer 2026. The order is based on stability observed in more than 3 manufactured registration batches and the Company's successful third-party audit of the manufacturing facility.

The Company expects that the initial manufacturing pace will be sufficient to support initial substantial yearly revenues and notes the ability to rapidly scale manufacturing as demand grows. The Company recently announced the appointment of Mr. Glenn Tyson as its Chief Commercial Officer and is in the process of retaining a full commercial team.

The NRx product is the first US-manufactured preservative-free ketamine presentation. Manufacturing is accomplished via a blow-fill-seal process that achieves more than 10-fold higher manufacturing throughput than traditional sterile bottling techniques that rely on glass vials and traditional seals.

NRx's presentation of ketamine differs from existing products in that it does not contain a known toxic preservative, Benzethonium Chloride. This preservative is no longer allowed to be included in new drugs and according to FDA policy cannot even be included in hand cleansers and topical antiseptics.