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ZYESAMI®

NRx Press Release
Jul. 1, 2022
FDA Declines Emergency Use Authorization for ZYESAMI® (aviptadil) for subgroup of Patients with Critical COVID-19 at immediate risk of death from respiratory failure despite treatment with approved therapy, including remdesivir

NRx Pharmaceuticals, Inc. today announced that the US Food and Drug Administration (FDA) has declined to issue an Emergency Use Authorization (EUA) for ZYESAMI® (aviptadil) for a sub-group of patients that in addition to ZYESAMI®, also received Remdesivir and continued to progress.

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NRx Press Release
May. 25, 2022
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.

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NRx Press Release
Apr. 21, 2022
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.

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NRx Press Release
Nov. 29, 2021
NRx Pharmaceuticals Identifies Significantly Higher Likelihood of Surviving and Recovering from Critical COVID-19 in ZYESAMI® (aviptadil) Treated Patients Previously Administered Remdesivir

Analysis was conducted in the subgroup of ZYESAMI- and placebo-treated patients who were previously treated with remdesivir in the COVID-AIV trial representing approximately 70 percent of the study population Analysis was conducted in response to US Food and Drug Administration (FDA) request for additional clinical data on effect of ZYESAMI compared to currently-approved therapy including […]

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CEO Update
Nov. 22, 2021
CEO Update: Denial of Breakthrough Therapy Designation

The US Food and Drug Administration (FDA) denied NRx Pharmaceuticals’ (NRx) request for Breakthrough Therapy Designation (BTD) for ZYESAMI® (aviptadil). BTD is not required for drug approval or emergency use authorization, but can afford faster review times, the ability to submit a rolling application, and dedicated FDA review personnel who may interact more frequently with […]

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