NRx Reports Positive Results For ZYESAMI; Submits EUA To Treat Critical COVID-19

Clinical-stage pharmaceutical company NRx Pharmaceuticals, Inc., (NRXP) announced Tuesday positive study results for ZYESAMI (Aviptadil-acetate). The company has filed an application with U.S. Food and Drug Administration requesting Emergency Use Authorization or EUA for ZYESAMI 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.

The filing was based on data requested from the FDA and Marks First Emergency Use Authorization Application Based on Randomized Prospective Data for Critical COVID-19.

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 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 2020.2

NRx previously requested limited EUA for highly co-morbid COVID-19 patients.

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