Wednesday, September 23, 2020 7:11:28 AM
“ Patients treated with RLF-100™ demonstrated a 3-fold advantage in survival, recovery from respiratory failure, and other parameters indicative of meaningful clinical improvement. Hypotension was seen in two aviptadil patients and was successfully managed with pressors. Diarrhea was seen in 4/21 aviptadil-treated patients and 3/30 control patients. The results have been submitted to a peer-reviewed journal.
The EUA application covers the same type of patients whom FDA has already allowed to receive treatment under the Expanded Access protocol authorized by the Agency in July. Tragically, we have found that many patients who might benefit from the Expanded Access protocol are hospitalized in centers that do not allow patients access to investigational drugs," said Jonathan Javitt, MD, MPH, Chairman and CEO of NeuroRx, "Our staff is working around the clock to address requests for RLF-100™ under the appropriate mechanism. All too often, patients of color and those of lower socioeconomic status are denied access."
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