NRx Receives Initial Report of Patient Safety and Survival from Right to Try use of ZYESAMI® (aviptadil) during Omicron Surge
JANUARY 26, 2022 6:51AM EST
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-A Southwestern hospital has reported safety data collected under the Federal Right to Try law indicating that 16 of 19 patients (84%) with COVID-19 respiratory failure treated with ZYESAMI® by Dec 31, 2021 have survived the ICU.
-No Serious Adverse Events were reported
-Patients were treated during the Omicron Surge
-Patients were treated at first onset of respiratory failure after exhausting remdesivir and other approved therapies
-Data are being included provided by NRx to FDA in support of ongoing application to FDA for Emergency Use Authorization
RADNOR, Pa., Jan. 26, 2022 /PRNewswire/ -- NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage, biopharmaceutical company, has received a first safety report from a Southwestern hospital where physicians have administered ZYESAMI® (Aviptadil) to patients with COVID-19 respiratory failure. These patients were treated under the Federal Right to Try Law that gives access to investigational medicines for patients who have been diagnosed with life-threatening diseases or conditions, who have tried all approved treatment options, and who are unable to participate in a clinical trial to access certain unapproved treatments. This Right to Try use of ZYESAMI occurred during the current Omicron surge, although patients were not necessarily tested for the specific COVID variant that caused their ICU admission.
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The safety update report received from the hospital indicated that of the first 19 patients treated by Dec. 31, 2021, three had died and 16 (84%) were reported to be alive by Jan. 22, 2021. At the time of the report, 14 of these 16 patients had been discharged to a rehabilitation center or home and two remained in the hospital. No Serious Adverse Events (SAEs) related to ZYESAMI were reported. These data were included in an application to FDA for Emergency Use Authorization for the treatment of patients with critical COVID-19 who are at immediate risk of death from respiratory failure despite treatment with approved therapy including remdesivir. NRx will continue to update the safety database collected under the Right to Try law on an ongoing basis.
The data being received from hospitals and patients treated under the Right to Try law do not involve a control group and are not part of a research study designed to test efficacy.
ZYESAMI continues to be tested in the ongoing NIH-sponsored ACTIV-3b (TESICO) trial that has now accrued two-thirds of its targeted enrollment.
