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NRx Pharmaceuticals Announces Expansion of ZYESAMI® (aviptadil) US Expanded Access and Right to Try Programs for Patients with COVID-19 Respiratory Failure who have Exhausted All Approved Treatments

NRx Pharmaceuticals 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.

CEO Update: Denial of Breakthrough Therapy Designation

The US Food and Drug Administration (FDA) denied NRx Pharmaceuticals’ (NRx) request for Breakthrough Therapy Designation (BTD) for ZYESAMI® (aviptadil). BTD is not required for drug approval or emergency use authorization, but can afford faster review times, the ability to submit a rolling application, and dedicated FDA review personnel who may interact more frequently with […]

CEO Update: ZYESAMI® (aviptadil) Next Steps

I recently received the letter below from a shareholder. The correspondence from them (taken exactly from their email) and my response regarding our next steps for ZYESAMI ® (aviptadil) can be found below. Email from R.B., a shareholder of NRx Pharmaceuticals Dear Dr. Javitt I have been heartbroken since the denied emergency approval for Zyesami/Aviptadil. […]

US Food and Drug Administration Declines Emergency Use Authorization for ZYESAMI® (aviptadil) for Patients with Critical COVID-19 with Respiratory Failure

NRx Pharmaceuticals Has Requested a Type A Meeting with US Food and Drug Administration (FDA) to Include Treating Physicians and Patients FDA Commits to Working with NRx to Develop ZYESAMI® ZYESAMI Clinical Trials Funded by the US National Institutes of Health and BARDA Continue and Advance Towards Enrollment in Brazil and Europe RADNOR, Pa., Nov. 4, […]

CEO Update: Ongoing Communications with the US Food and Drug Administration

NRx Pharmaceuticals continues to receive many requests for updates on the status of the US Food and Drug Administration’s (FDA) review of NRx’s application for Emergency Use Authorization (EUA) of ZYESAMI™ (aviptadil), to treat patients suffering from Critical COVID-19 with respiratory failure. On September 3, 2021, NRx received a request for additional clinical information from […]