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State: 17.08.2024 | 11PM
Mon, 30.09.2024       NRx Pharmaceuticals
US6294441000

Stability milestone supports submission of FDA New Drug Application by NRx for the use of intravenous ketamine to treat Suicidal DepressionKetamine is currently used off-label for this indication. However, FDA approval is typically required for patients to obtain insurance reimbursementNRX-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.

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