Stability milestone supports submission of FDA New Drug Application by NRx for the use of intravenous ketamine to treat Suicidal Depression Ketamine is currently used off-label for this indication. However, FDA approval is typically required for patients to obtain insurance reimbursement NRX-100 is the first preservative-free formulation of Ketamine, potentially avoiding toxic side effects of preservatives used in current preparations designed for single dose anesthetic use RADNOR, Pa. , Sept.
30, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP ), a clinical-stage biopharmaceutical company, ("NRx," the "Company"), today announced that twelve-month real-time stability on the first manufactured lot of NRX-100 (Ketamine) 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 effect.
