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NRx Pharmaceuticals Receives US Food and Drug Administration Review of ZYESAMI® (aviptadil) Manufacturing Information
US Food and Drug Administration Review Allows for High Volume Production of ZYESAMI® (aviptadil)Shelf Life of ZYESAMI Now Extended from 62 Days to 150 Days
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"US Food and Drug Administration Review Allows for High Volume Production of ZYESAMI® (aviptadil)Shelf Life of ZYESAMI Now Extended from 62 Days to 150 Days RADNOR, Pa., Nov. 11, 2021 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals (NASDAQ: NRXP), today announced receipt of the US Food and Drug Administration’s (FDA) response to NRx’s October 8 submission of updated manufacturing information for ZYESAMI® (aviptadil). The completion of this review, without the imposition of any clinical hold by the FDA, enables NRx to distribute ZYESAMI, produced at commercial scale, under Good Manufacturing Practices (GMP) for clinical trials and other future purposes approved in future regulatory actions. NRx looks forward to working with the FDA to complete the chemistry, manufacturing, and controls (CMC) review that will ultimately be required for any potential drug approval. Prior to the COVID pandemic, ZYESAMI was never manufactured as a commercial drug for intravenous use. Between March and May 2020, NRx formulated aviptadil based on historical files and initiated an FDA-approved, phase 2b/3 clinical trial by producing ZYESAMI in an FDA-inspected 503b pharmacy. Until now, ZYESAMI was manufactured for clinical trials purposes in handmade, 300 dose batches, with a limited shelf life of 62 days. The FDA has now reviewed a GMP manufacturing process at a batch size of 10,000 – 100,000 doses with a current shelf life of 150 days and identified no basis for a clinical hold. “This represents the first time aviptadil has been manufactured in an FDA-inspected commercial GMP environment for intravenous and inhaled use and passed regulatory review of manufacturing and CMC. With the help of our partners at Nephron Pharmaceuticals, we have validated the analytic techniques required to test the purity, potency, and stability of our medicine as required by the FDA and other regulators. We have advanced a generic ingredient (aviptadil) into a modern drug that meets GMP specifications, and that can be manufactured at commercial scale, cost, and shelf life,” said Prof Jonathan Javitt, MD MPH Chairman and CEO NRx Pharmaceuticals. “While we continue to focus on proving clinical safety and efficacy in the treatment of COVID-19, we now have an investigational drug platform, reviewed by FDA, that enables us to investigate the use of ZYESAMI in both intravenous and inhaled...