NRx was the first to formulate aviptadil for human intravenous and inhaled use under the "Good Manufacturing Practices" standards in 2020. Zyesami (Aviptadil) (RLF-100) COVID-19 therapeutic has received orphan drug designation from the U.S. Food and Drug Administration (FDA) in acute respiratory distress syndrome, chronic lung diseases, and the treatment of sarcoidosis. In June 2020, the FDA awarded Fast Track Designation to NRx for the use of aviptadil for the treatment of Acute Lung Injury/Acute Respiratory Distress Syndrome associated with COVID-19.
Additionally, the U.S. FDA has approved an expanded access protocol for the use of RLF-100 in patients with Critical COVID-19 and Respiratory Failure. The purpose of this expanded access program is to serve patients with a life-threatening need who don't qualify for or cannot access the FDA phase 2/3 clinical trials currently underway. Patients will be treated with 12-hour infusions of RLF-100 at ascending doses of 50/100/150 pmol/kg/hr on three successive days. Those respiratory conditions include Acute Respiratory Distress Syndrome, Chronic Obstructive Pulmonary Disease, acute smoke inhalation, sarcoidosis, and checkpoint inhibitor pneumonitis.
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