Nrx Pharmaceuticals, Announces Expanded Access And Right To Try Programs, To Provide ZYESAMI, To Treat Covid-19 Patients
NRx Pharmaceuticals, on Tuesday, announced enhancements to its Expanded Access and Right to Try programs. The right to try programs enables the patients who have tried all approved medicines, including remdesivir, and who are not able to participate in a clinical study, with respiratory failure from COVID-19, to receive ZYESAMI (aviptadil) as the final resort.
As a result of this expansion, the supplies of ZYESAMI have increased through the partnership between NRx and Nephron Pharmaceuticals. The firms are manufacturing ZYESAMI at a commercial scale. It is expected that the expanded production will also support the ongoing ACTIV-3b trial conducted by the National Institutes of Health (NIH) both in the US and Brazil.
“Given the urgency caused by the Omicron surge, we have worked with our manufacturing partner to increase production to a level that supports expanded access to our investigational medicine ZYESAMI, potentially at all US hospitals. We will continue to increase production to meet demand in order to offer one last option to patients who have exhausted all currently approved therapies,”Prof. Jonathan C. Javitt, MD, MPH, CEO and Chairman of NRx Pharmaceuticals
ZYESAMI is a long-term stable form of the vasoactive intestinal peptide, which was previously shown in clinical trials to be associated with a two-fold increased odds of survival at 60 days. While the Adverse events included principally diarrhea and hypotension of patients. As of now, ZYESAMI remains an investigational medicine that is not approved by the US FDA. The NIH is currently studying ZYESAMI as part of its ACTIV-3b trial, which has enrolled approximately two-thirds of patients and has not identified unexpected safety concerns.
Hospitals that enroll in the FDA-supervised Expanded Access Program (EAP) are able to store ZYESAMI on-site and provide it to patients without delay. While the patients who are hospitalized at facilities not enrolled in the EAP program may be treated under the Federal Right to Try Act, which does require an application to NRx by a licensed, accredited critical care physician and review by the Company’s medical team.