NRx Pharmaceuticals, Inc. (NRXP) has seen a decrease of 33.97% in the premarket. However, the last trading session closed at $8.92 with a decline of 5.01%.
Emergency Use Authorization for ZYESAMI
On 4th November 2021, NRXP announced that ZYESAMI has been denied an Emergency Use Authorization (EUA) by the US Food and Drug Administration (aviptadil). The FDA noted that it was unable to give the EUA at this time owing to a lack of evidence on the medicine’s recognized and prospective benefits, as well as the hazards of ZYESAMI in patients with Critical COVID-19 and respiratory failure. Moreover, the FDA stated that it had only evaluated the safety of ZYESAMI in 131 randomized individuals. The 150 or more patients currently treated with ZYESAMI in the NIH ACTIV-3b study will be reviewed by the FDA, which NRx will endeavor to coordinate.
The continuing NIH ACTIV-3b experiment was evaluated by the study’s Data Safety and Monitoring Board last week, and no new safety problems were discovered. Despite extensive immunization and currently-available approved therapies, more than 1,500 Americans and many more across the globe died of COVID-19 alone in ICUs, separated from their loved ones. Lastly, NRXP felt that ZYESAMI has shown a high level of safety, as well as a two-fold boost in ICU survival rates as patients treated with it at the country’s top hospitals, had a four-fold increase in survival rates.
New Safety Report for ZYESAMI
NRXP reported on 2nd November 2021 that ZYESAMI, which is being studied in the ACTIV-3b Critical Care Phase 3 research supported by the National Institutes of Health, has received a new safety update. After examining more than 300 patients in its third planned analysis, the study’s Independent Data Safety Monitoring Board found no new safety issues and recommended that enrolment be maintained. This safety review by the NIH continues to offer evidence that ZYESAMI is safe to deliver to patients with Critical COVID-19 who have no other treatment choice.
Moreover, this safety review by the NIH continues to offer evidence that ZYESAMI is safe to deliver to patients with Critical COVID-19 who have no other treatment choice. The company now has safety data on approximately 600 patients who were treated with ZYESAMI in the ICU or step-down unit, and there have been no reports of unanticipated, drug-related major side events.
Positive Trial Data of Aviptadil
NRXP reported on 14th October 2021 that the results of a controlled study of aviptadil for the treatment of respiratory failure in patients with Critical COVID-19 were recently published in peer-reviewed journals. The study found that 81 percent of individuals treated with aviptadil survived 60 days, compared to only 21% of those treated with conventional care at Houston Methodist Hospital. Because of substantial comorbidities, patients involved in this trial were disqualified for the phase 2b/3 pivotal study of aviptadil for the treatment of COVID-19 with respiratory failure.
Moreover, during the first wave of the pandemic in the summer of 2020, participants in the trial did not respond to any of the approved COVID-19 medications. The study found statistically significant benefits in the aviptadil-treated group on two crucial intermediate endpoints: Respiratory Distress Ratio and Cytokine IL-6, in addition to the significant differences in survival and recovery. Lastly, experts figured out significant differences in findings from the phase 2b/3 randomized controlled trial of aviptadil vs. placebo done at ten locations across the United States.
