NRx Pharmaceuticals continues to receive many requests for updates on the status of the US Food and Drug Administration’s (FDA) review of NRx’s application for Emergency Use Authorization (EUA) of ZYESAMI™ (aviptadil), to treat patients suffering from Critical COVID-19 with respiratory failure. On September 3, 2021, NRx received a request for additional clinical information from […]
Critical COVID-19
A year ago, at FDA’s request, NRx began a compassionate care (Expanded Access) program to make aviptadil more available to patients in need. We have reported our experience in nearly 350 patients, and numerous patients and families have shared their stories in various public forums. The compassionate care program was, of necessity, limited to a […]
Agreement Represents Path to Market for ZYESAMI™, as Time to Treatment is Crucial for Patients Cardinal Health Third Party Logistics Services to Provide Logistical and Distribution Support for ZYESAMI™ (aviptadil) Upon Potential FDA Approval Cardinal Health Specialty Pharmaceutical Distribution to Serve as the Exclusive Distributor to Ensure Access to ZYESAMI™ (aviptadil) Upon Potential FDA Approval […]
After Review of Approximately 140 patients in ACTIV-3 Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board, Study to Continue Enrollment to Target More than 600 Patients ACTIV-3 Critical Care is a Public-Private Partnership Sponsored by the US National Institutes of Health to Treat COVID-19 ACTIV-3 Critical Care is Evaluating […]
We have received questions about the data submitted to the US Food and Drug Administration (FDA) in support of our application for Emergency Use Authorization for ZYESAMI™ to treat patients suffering from Critical COVID-19 with respiratory failure. Since there seems to be some confusion about what the preprint says, I’m going to restate the science. ALL PATIENTS […]
On Wednesday, July 21, 2021, Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals, participated in a panel discussion hosted by the Disease Prevention & Control Summit. The specific panel discussion focused on small molecules and repurposed medicines for COVID-19 treatment. Jonathan received several questions from those watching the panel discussion. Below, are […]
Sudden Rise in Inflammatory Cytokines (IL-6) Associated with Death in COVID-19 and Other Forms of Acute Respiratory Distress Syndrome Data from Randomized Phase 2b/3 Trial Shows Patients Treated with ZYESAMI™ are Significantly Less Likely to Experience IL-6 Cytokine Rise, and Have Improved Survival and Recovery from Respiratory Failure, Compared to Patients Receiving Placebo Data Have […]
NRx Pharmaceuticals, Inc. and Quantum Leap Healthcare Collaborative™ have begun treating patients with inhaled ZYESAMI™ (Aviptadil), in the I-SPY COVID Trial (NCT04488081),
PR Newswire RADNOR, Pa. and TBLISI, Georgia, April 28, 2021 /PRNewswire/ — NeuroRx today announces that it has met with Dr. Ekaterine Tikaradze, Minister of Health of Georgia, and other senior leadership, to immediately initiate an Expanded Access Program (EAP) of its phase 3 drug, ZYESAMI (aviptadil acetate) for critically-ill citizens of Georgia with COVID-19 Respiratory Failure. The EAP will be conducted in […]