NRx Pharma : FDA Denies Breakthrough Therapy Designation Request For Zyesami

(RTTNews) - NRx Pharmaceuticals Inc. (NRXP) said that the U.S. Food and Drug Administration denied the breakthrough therapy designation request for Zyesami or aviptadil and emphasized its focus on the company's NRX-101 BTD compound for Bipolar Depression associated with Suicidality.

The request for breakthrough therapy designation was submitted based on the positive finding of a post-hoc subgroup analysis of patients who in addition to Aviptadil or placebo were also treated with Remdesivir and whose respiratory failure due to Critical COVID-19 continued to progress.

The company noted that it will further evaluate the options for Zyesami's use in other high unmet pulmonary as well as other non-pulmonary indications.

"Although we are disappointed about FDA's decision, as recently announced, our strategic focus has already shifted to the advancement of our Breakthrough Therapy designation drug NRX-101," the company said. The company expects topline data for its ongoing Phase II study of NRX-101 in patients with bipolar depression with sub-acute suicidal ideation (SSIB) by the end of the year.