NRx Pharmaceuticals, Inc. today announced that the FDA denied the Breakthrough Therapy designation (BTD) request for ZYESAMI® (aviptadil) and emphasizes focus on its NRX-101 BTD compound for Bipolar Depression associated with Suicidality.
NRx Pharmaceuticals, Inc. today announced results of a review conducted by the Data Safety and Monitoring Board (DSMB) on May 25, 2022. The DSMB reviewed data of approximately 460 patients with Critical COVID-19 Respiratory Failure who were enrolled in the ACTIV-3b (TESICO) trial, most of which had reached the 90-day endpoint.
NRx Pharmaceuticals, Inc. today announced that it has filed a new Breakthrough Therapy designation request with the U.S. Food and Drug Administration (FDA) focused on a subgroup of patients with Critical COVID-19 that in addition to aviptadil or placebo were also treated with remdesivir. The request includes safety data on approximately 750 patients treated with intravenous ZYESAMI® for Critical COVID-19.
Quantum Leap Healthcare Collaborative (QLHC) announced in collaboration with NRx Pharmaceuticals, Inc. (NRx), that the nebulized form of ZYESAMI® (Aviptadil), in the I-SPY COVID Trial of Critical COVID-19 patients has been stopped.
Key data from the phase 2b/3 trial of ZYESAMI vs. Placebo (COVID-AIV) for treating patients with Respiratory Failure in Critical COVID-19 were presented at the February 2022 Congress on Retroviruses and Opportunistic Infections (CROI).
Source – https://spotonflorida.com/north-central-florida/3555710/lauds-mothers-covid-recovery-after-experimental.html?fbclid=IwAR31nFkp71HPsff_C9YKR84H9KzNpWavAbjlQWJ8FRrlQI8zWNnmnGo0Bb8
NRx Pharmaceuticals today announced results of a review conducted by the Therapeutics and Prevention Data Safety and Monitoring Board (DSMB) of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).
NRx Pharmaceuticals has received a first safety report from a Southwestern hospital where physicians have administered ZYESAMI® (Aviptadil) to patients with COVID-19 respiratory failure.
NRx Pharmaceuticals announced enhancements to its Expanded Access and Right to Try programs. The programs enable patients with respiratory failure from COVID-19, who have tried all approved medicines, including remdesivir, and who are not able to participate in a clinical study, to receive ZYESAMI® (aviptadil) upon a physician’s prescription.
