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 […]
Critical COVID-19
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 […]
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., April 26, 2021 /PRNewswire/ — Dosing of the first patient in a phase 3 clinical trial of ZYESAMI (aviptadil acetate) was announced by the National Institutes of Health (NIH) last week. The trial, designated as ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 (TESICO) (www.clinicaltrials.gov NCT04843761), will study ZYESAMI to treat severely ill COVID-19 patients. The […]
Patients with acute respiratory failure may now enroll in NIH-sponsored trial. National Institutes of Health – News Releases A new Phase 3 trial to test the safety and efficacy of therapeutics for COVID-19 has begun enrolling patients hospitalized with life-threatening cases of COVID-19, including those with acute respiratory failure. The trial is supported by two […]
CISON PR Newswire RADNOR, Pa., April 19, 2021 /PRNewswire/ — The issues raised by Relief Therapeutics in its release dated April 19, 2021 have no bearing on NeuroRx’s ability or commitment to deliver a safe, effective, and stable lifesaving drug on a worldwide basis. However, NeuroRx was obligated to disclose Relief’s nonpayment of development costs required under the signed collaboration […]
CISON PR Newswire RADNOR, Pa., April 6, 2021 /PRNewswire/ — NeuroRx, Inc. reports today that Aviptadil, to be supplied by NeuroRx, has been identified by the National Institutes of Health (NIH) as one of two drugs selected for inclusion in a phase III multicenter clinical trial that will include the United States and multiple foreign countries. Aviptadil is being developed […]