NRx Pharmaceuticals announces completion of 12 months of stability of NRX-100

NRx Pharmaceuticals announced that twelve-month real-time stability on the first manufactured lot of NRX-100 at Nephron Pharmaceuticals, utilizing commercial scale processes, was reached on September 24, 2024. In this process, no degradation of the active ingredient was observed. These findings are consistent with projected room temperature shelf stability in excess of three years. Accelerated stability on additional manufactured lots of preservative-free product is congruent with stability seen in this initial lot. Demonstrating the ability to manufacture drug product, and prove its stability, are critical components of the drug approval process with the US FDA. Filing of the NDA for NRX-100 is on track for 2024. The NRX-100 formulation is the first sterile, single dose vial prepared with without the addition of preservatives, which may have toxic effects with repeated use.