NRx Pharmaceuticals (NASDAQ: NRXP) Announces Initial End-Market Formulation of ZYESAMI (Aviptadil), Enabling Accelerated Manufacturing


NRx Pharmaceuticals (NASDAQ: NRXP) announced the validation of the first commercial formulation of ZYESAMI (aviptadil) for intravenous use, allowing high volume production.

NRx increased the production of aviptadil

Likewise, the company increased the aviptadil production batch size 30 to 50 times while reducing the cost of its peptide supply by 90%. As prospective regulatory clearances in various parts of the world are obtained, these two innovations position NRx to potentially deliver millions of doses of ZYESAMI.

CEO and Chairman Jonathan Javitt said, “When we started developing aviptadil for the treatment of COVID-19, we found that the original formulation and manufacturing method of RLF-100 was only a few weeks old. stability, leaving hospitals unable to store the investigational drug in pharmacies. , and leaving aviptadil out of consideration for national strategic stocks. In addition, the high cost of the peptide and the inability to manufacture more than 100 grams per month limited the commercial utility of aviptadil.

The company created and validated the first modern chromatography tests necessary to ensure the stability and purity of the drug. In addition, the high speed production and new formulation method accommodates the fragile nature of the vasoactive intestinal peptide.

NRx seeks EMA for aviptadil in US

As NRx continues to seek emergency use authorization in the United States, the successful new formulation and increased production of ZYESAMI allows it to re-launch the extended access and trial rights campaigns. The programs are intended for COVID-19 patients at high risk of death and who have exhausted all other treatment options from trying ZYESAMI on an experimental basis.

NRx Scientific Advisor Ricardi Panicuccci said: “We started this project a year ago, with 9 days of stability and a capacity to manufacture around 100 doses of the drug each day. We have learned through extensive studies and testing that the significant biological activity of this small peptide is accompanied by a fragile molecular structure that is destroyed by standard high volume pharmaceutical manufacturing processes.


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