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NRx Pharmaceuticals Announces Positive Data Results from ZYESAMI™ (Aviptadil) Expanded Access Protocol
- Expanded Access Protocol (EAP) Included 240 ICU Patients Suffering Critical COVID-19 with Respiratory Failure who had Exhausted All Approved Therapies -
About this update from Nrx Pharmaceuticals, Inc.
[{"type":"text","content":"- Expanded Access Protocol (EAP) Included 240 ICU Patients Suffering Critical COVID-19 with Respiratory Failure who had Exhausted All Approved Therapies\n - Sixty-Five Percent of Patients Receiving ZYESAMI™ (Aviptadil) and Maximal Intensive Care were Alive at 28 Days\n - Survival was Higher in those Treated with High Flow Nasal Cannula than those Treated with Mechanical Ventilation (76% vs. 54%)\n - Results from EAP are Congruent with the Randomized Control Phase 2b/3 ZYESAMI™ (Aviptadil) Trial Data Submitted to US Food and Drug Administration (FDA) in Support of Emergency Use Authorization (EUA)\n - EAP Data to be Submitted to US FDA in Support of EUA Filing\n\n\nRADNOR, Pa., June 15, 2021 /PRNewswire/ -- NRx Pharmaceuticals (Nasdaq: NRXP), a clinical stage pharmaceutical company, today announced positive data from its ZYESAMI™ (Aviptadil) Expanded Access Protocol (EAP). Overall, patients receiving at least one dose of ZYESAMI™ in addition to intensive care were alive at 28 days. This EAP (https://clinicaltrials.gov/ct2/show/NCT04453839) provided an opportunity for many regional hospitals to offer ZYESAMI™ to its sickest patients, for whom no other options were available, and who could not enroll in a study due to additional risk factors. Fifty-six percent of patients enrolled were already receiving mechanical ventilation, and 44% were receiving non-invasive forms of ventilation, mostly high nasal flow cannula. (HFNC). \n\n \n \n \n \n \n \n\n \nNRx Pharmaceuticals Announces Positive Data Results from ZYESAMI™ (Aviptadil) Expanded Access Program\"We initiated the ZYESAMI™ EAP at FDA's request, to gain real-world evidence from patient outcomes outside of the clinical trial environment. Working with 42 U.S. medical centers and hospitals, we were able to see the outcomes ZYESAMI™ provided to some of sickest of COVID-19 patients,\" said Jonathan Javitt, MD, MPH, CEO and Chairman of the Board, of NRx. \"While vaccinations have markedly reduced the incidence of COVID-19 in some countries, effective medicines remain critical for the tens of thousands who continue contracting COVID-19 and the expanding numbers of variants associated with this virus.\"\nEnrollment in the EAP was offered to patients who were ineligible for the ZYESAMI™ phase 2b/3 clinical trial, and who had exhausted all approved therapies for COVID-19. The enrollment in...