US Food and Drug Administration May Approve NRx Pharmaceuticals

Following the probable Emergency Use Authorization approval by the US Food and Drug Administration, NRx Pharmaceuticals said today that it has struck an agreement with Cardinal Health to supply third-party logistics and distribution of ZYESAMI. NRx submitted an EUA application to the Food and Drug Administration in May for ZYESAMI for patients with Critical COVID-19 and respiratory failure. For NRx, this alliance enables a highly efficient and adaptable logistics and distribution platform.

Robert Besthof, Head of Operations and Chief Commercial Officer of NRx, said, “This partnership creates an efficient and highly flexible logistics and distribution model for NRx. Cardinal Health’s expertise will enable ZYESAMI to quickly reach patients in the intensive care units, as limiting the time to treatment is crucial. This also allows NRx to continue focusing on answering requests from the US Food and Drug Administration in support of our application for Emergency Use Authorization for ZYESAMI.”

Following Food and Drug Administration approval, Cardinal Health Specialty Pharmaceutical Distribution will be the only distributor for ZYESAMI, providing hospitals with broad access to this critical treatment. Cardinal Health, which operates one of the country’s major healthcare supply chains, serves more than 90% of hospitals in the United States and has more than 20 years of experience supporting the quick delivery of lifesaving drugs.

Cardinal Health’s Third-Party Logistics Services (3PL) will also help with warehousing and distribution, as well as full order to cash and title model services. ZYESAMI is a synthetic variant of Vasoactive Intestinal Polypeptide (VIP), which was first discovered in 1970 by the late Prof. Sami Said and is named after him. It was originally purified from the digestive tract, despite the fact that it is largely concentrated in the lungs.