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Aviptadil

NRx Pharmaceuticals Announces Data Safety Monitoring Board (DSMB) Update on U.S. National Institutes of Health (NIH) Study of ZYESAMI® (aviptadil) in Critical COVID-19

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 Files New Breakthrough Therapy Designation Request for ZYESAMI® (aviptadil) in Subgroup of Patients with Critical COVID-19 with Respiratory Failure that were also treated with Remdesivir and continued to progress

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.

NRx Pharmaceuticals Announces Expansion of ZYESAMI® (aviptadil) US Expanded Access and Right to Try Programs for Patients with COVID-19 Respiratory Failure who have Exhausted All Approved Treatments

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.