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. […]
Aviptadil
After Review of More than 300 Enrolled Patients in ACTIV-3b Critical Care Study, No New Safety Concerns Raised by Independent Data Safety Monitoring Board; Study Cleared to Continue Enrollment to Target 640 Patients ACTIV-3b Critical Care Study is Evaluating ZYESAMI® (aviptadil) and Remdesivir, in Critical COVID-19 Patients, as Monotherapy and in Combination Against Placebo ACTIV-3b […]
We have received several questions about the status of the Emergency Use Authorization granted to aviptadil in the Nation of Georgia. Attached please find a copy of the official notification from the Regulation Agency for Medical and Pharmaceutical Activities of the Nation of Georgia, that states as follows: 06 August 2021 Georgian Respiratory Association to […]
Seventeen of 21 Patients Treated with Aviptadil Survived to Day 60 Compared to 5 of 24 in the Controlled Group of Patients RADNOR, Pa., Oct. 14, 2021 /PRNewswire/ — NRx Pharmaceuticals (Nasdaq: NRXP), today announced the publication of peer-reviewed results from a prospective, open-label, administratively controlled trial of aviptadil for the treatment of respiratory failure in patients with Critical COVID-19. […]
RADNOR, Pa., Oct. 12, 2021 /PRNewswire/ — NRx Pharmaceuticals (Nasdaq: NRXP), today announced that a revised Investigational New Drug module on the manufacturing of ZYESAMI™ (aviptadil) was submitted to the US Food and Drug Administration (FDA), containing documentation that confirmed Nephron Pharmaceuticals, Inc. is prepared to supply ZYESAMI on a commercial scale. This module will now be used as part of […]
NRx is pleased to announce that last week a revised Investigational New Drug module on the manufacturing of ZYESAMI™ (aviptadil) was submitted to the US Food and Drug Administration (FDA), containing documentation that confirmed Nephron Pharmaceuticals, Inc. is prepared to supply ZYESAMI on a commercial scale. This module will now be used as part of […]
ZYESAMI™ (aviptadil) Has Previously Demonstrated a Statistically Significant Increase in Survival of Highly Comorbid COVID-19 Patients in Two 60-day Trials In a Study of Highly Comorbid Patients, ZYESAMI Provided a Threefold, Statistically Significant Increase in Likelihood of Survival at One Year RADNOR, Pa., Sept. 27, 2021 /PRNewswire/ — NRx Pharmaceuticals (Nasdaq: NRXP), a clinical stage, biopharmaceutical […]
You may have noted a previous update regarding communication with the FDA. Earlier this month, NRx received a request for additional clinical information from the FDA. NRx has responded to the information request issued by the FDA with regard to additional clinical information on study patients. Ongoing conversations between the FDA and sponsor of any application […]
I received a very interesting question the other day regarding the history of aviptadil and any regulatory milestones associated with it as a medicine. Below, I outline a brief history of aviptadil and why we believe it may offer patients suffering respiratory distress the opportunity to regain health and get back home to their families. […]