The United States Food and Drug Administration (FDA) has received a request for Emergency Use Authorisation from NeuroRx Inc, a clinical stage, small molecule pharmaceutical company, for its RLF-100™ aviptadil, it was reported on Wednesday.
RLF-100 aviptadil is intended for patients with Critical COVID-19 and Respiratory Failure who are receiving intensive care and who have exhausted all approved treatments. The product is being developed by NeuroRx as part of a global collaboration with Relief Therapeutics Holdings, SA (SIX:RLF;OTCQB:RLFTF).
The company has submitted the application based on a case-control study that compared patients who were treated with RLF-100 (n=21) to those receiving maximal standard of care treatment (n=30) in the same ICU by the same medical staff. Patients treated with the product indicated a threefold advantage in survival, recovery from respiratory failure, and other parameters indicative of meaningful clinical improvement.
The company has submitted the results to a peer-reviewed journal.
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