NRx Pharmaceuticals, Inc. today announced that the FDA denied the Breakthrough Therapy designation (BTD) request for ZYESAMI® (aviptadil) and emphasizes focus on its NRX-101 BTD compound for Bipolar Depression associated with Suicidality.
NRx Pharmaceuticals, Inc. today announced that it has filed a new Breakthrough Therapy designation request with the U.S. Food and Drug Administration (FDA) focused on a subgroup of patients with Critical COVID-19 that in addition to aviptadil or placebo were also treated with remdesivir. The request includes safety data on approximately 750 patients treated with intravenous ZYESAMI® for Critical COVID-19.
Key data from the phase 2b/3 trial of ZYESAMI vs. Placebo (COVID-AIV) for treating patients with Respiratory Failure in Critical COVID-19 were presented at the February 2022 Congress on Retroviruses and Opportunistic Infections (CROI).
The US Food and Drug Administration (FDA) denied NRx Pharmaceuticals’ (NRx) request for Breakthrough Therapy Designation (BTD) for ZYESAMI® (aviptadil). BTD is not required for drug approval or emergency use authorization, but can afford faster review times, the ability to submit a rolling application, and dedicated FDA review personnel who may interact more frequently with […]
Recently, we’ve received several questions about the Breakthrough Therapy Designation (BTD) application NRx submitted to the US Food and Drug Administration (FDA) for ZYESAMI™ (aviptadil) last month. As you know, we received BTD for our psychiatry drug NRX-101 for suicidal bipolar depression. Admission to the BTD program provided us with increased access to review guidance […]