Benzinga | Jun 1, 2021 12:15PM EDT

NRx Files for Zyesami Emergency Use in Critical COVID-19 Patients With Respiratory Failure

* NRx Pharmaceuticals (NASDAQ:NRXP) has applied with FDA requesting Emergency Use Authorization (EUA) for Zyesami (Aviptadil-acetate) for critically ill COVID-19 patients suffering from respiratory failure.

* Consistent with previously announced top-line data, the study identified a statistically significant increase in the likelihood that patients treated with Zyesami would be alive and free of respiratory failure at 60 days, compared to those treated with placebo, and identified a significantly shorter median hospital stay.

* The study enrolled 196 participants who were randomized and treated with either Zyesami or placebo, in addition to maximal standard of care at 10 US hospitals.

* Patients in earlier stages of respiratory failure (those treated with high flow oxygen) were more likely to survive and recover than those who had already progressed to ventilation.

* However, statistically significant benefits in the prespecified endpoint were demonstrated in both groups.

* NRx previously requested limited EUA for highly co-morbid COVID-19 patients. FDA further requested randomized, prospective data regarding Zyesami, which are represented in this filing.

* Separately, the National Institutes of Health is conducting a confirmatory trial that randomizes patients with COVID-19 respiratory failure to Zyesami versus Gilead Sciences Inc's (NASDAQ:GILD) Veklury (remdesivir) and placebo in a factorial design trial.

* A second nationwide trial to determine if similar benefits may be achieved in critically ill patients with inhaled Zyesami is being conducted on the I-SPY platform, maintained by the Quantum Leap Healthcare Collaborative.

* Price Action: NRXP shares are down 3.8% at $21.16 during the market session on the last check Tuesday.