On Jun. 2, 2021, NRx Pharmaceuticals announced it had filed an application with U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for ZYESAMI™ (Aviptadil-acetate), to treat Critically Ill COVID-19 patients suffering with 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 clinical study report filed with FDA further documents statistically significant advantages for ZYESAMI™ on all major secondary endpoints.

Patients enrolled in the study had respiratory failure despite prior treatment with all approved medicines for COVID-19 including remdesivir. Other therapies administered included steroids, anticoagulants, and various monoclonal antibodies. Although antiviral treatment has shown advantages in treating patients with earlier stages of COVID-19. ZYESAMI™ is the first reported medicine to demonstrate increased recovery and survival in patients who have already progressed to respiratory failure. The randomized controlled trial outcomes remain similarly consistent with the open-label, administratively controlled trial reported in October 2020.

The study enrolled one hundred ninety-six 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.