RADNOR, PA — NRx Pharmaceuticals (NRx) (NASDAQ: NRXP) recently provided a safety update on ZYESAMI™ (aviptadil) which is being tested in the ACTIV-3b Critical Care Phase 3 study sponsored by the National Institutes of Health. In its second scheduled analysis, the study’s Independent Data Safety Monitoring Board found no new safety concerns, after reviewing a total of 231 patients, and recommended continued enrollment.
“With this second independent safety analysis in the ACTIV-3b trial, the safety database on ZYESAMI has grown to more than 500 patients across our various clinical trials and expanded access programs. So far, there have been no reports of unexpected, drug-related serious adverse events,” said Prof. Jonathan Javitt, MD, MPH, Chairman and CEO of NRx.
ACTIV-3b is a randomized, placebo-controlled trial testing ZYESAMI™ and remdesivir (Veklury) — alone and in combination — in hospitalized patients with acute respiratory failure due to COVID-19 who require high-flow supplemental oxygen delivered by nasal cannula, mechanical ventilation, or extracorporeal membrane oxygenation.
ACTIV-3b represents one of three ongoing studies of ZYESAMI™ in Severe or Critical COVID-19.
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