NRx Pharmaceuticals announced today that it has reached an agreement with MannKind Corporation to develop a dry powder formulation of ZYESAMITM (aviptadil), a synthetic form of human Vasoactive Intestinal Peptide (VIP), which is produced by the body to protect cells from inflammatory conditions. MannKind’s proven Technosphere® technology will be used to develop the inhaled insulin product Afrezza®, which has been approved by the US Food and Drug Administration (FDA).
In June 2020, the FDA granted NRx a Fast Track Designation for the use of aviptadil in the treatment of COVID-19-associated Acute Lung Injury/Acute Respiratory Distress Syndrome. In a phase 2b/3 clinical trial, the investigational medicine showed a more than 2-fold enhanced chance of survival at 60 days and dramatically reduced IL-6 cytokine production when compared to placebo. The US National Institutes of Health, the Biomedical Advanced Research Development Authority (BARDA).
With aviptadil’s therapeutic effects now being seen in clinical studies, NRx is shifting its focus to developing a simple, room-temperature inhalation administration device that is both convenient for patients and has already been validated in commercial production. To improve patient health, NRx Pharmaceuticals draws on more than 300 years of combined scientific and drug-development knowledge. The US Food and Drug Administration (FDA) has granted ZYESAMITM for patients with COVID-19 Fast Track designation.