RADNOR, PA — NRx Pharmaceuticals (Nasdaq: NRXP) this week announced enhancements to its Expanded Access and Right to Try programs. The programs enable patients with respiratory failure from COVID-19, who have tried all approved medicines, including remdesivir, and who are not able to participate in a clinical study, to receive ZYESAMI® (aviptadil) upon a physician’s prescription.
This expansion comes as supplies of ZYESAMI have increased through the partnership between NRx and Nephron Pharmaceuticals, which is manufacturing ZYESAMI at commercial scale. 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.
ZYESAMI is a long-term stable form of vasoactive intestinal peptide, which was previously shown in clinical trials to be associated with a two-fold increased odds of survival at 60 days. The subgroup of patients who were treated with ZYESAMI after remdesivir and other approved therapies demonstrated a 2.8-fold increased odds of recovering from respiratory failure by day 28 (P=.03), which was sustained to day 60, together with a four-fold increased odds of surviving to day 60 (P=.006). Adverse events included principally diarrhea (33% aviptadil vs 1.5% placebo) and hypotension (26% aviptadil vs 22% placebo) of patients. Detailed data on results seen in clinical trials of ZYESAMI® (Aviptadil) may be viewed on the NRx website (https://www.nrxpharma.com/right-to-try/). 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 (TESICO) trial (https://clinicaltrials.gov/ct2/show/NCT04843761), 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.
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.
“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,” said Prof. Jonathan C. Javitt, MD, MPH, CEO and Chairman of NRx Pharmaceuticals.
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