NRx Pharmaceuticals (NASDAQ: NRXP) has announced the validation of the first commercial ZYESAMI (aviptadil) formulation for intravenous use, permitting high volume production.
NRx has increase aviptadil production
Equally, the company has increased the production lot size of aviptadil by 30 to 50 times while lowering the cost of its peptide supply by 90%. As prospective regulatory clearances in various areas across the world are achieved, these two innovations position NRx to potentially administer millions of ZYESAMI doses.
CEO and Chairman Jonathan Javitt said, “When we began developing aviptadil for treatment of COVID-19, we discovered that the original RLF-100 formulation and manufacturing method had only a few weeks of stability, leaving hospitals unable to stock the investigational medicine in pharmacies, and leaving aviptadil out of consideration for national strategic stockpiles. Moreover, the high cost of peptide and an inability to manufacture more than 100 grams a month limited the commercial utility of aviptadil.”
The company has created and validated maiden modern chromatography assays necessary to ensure the stability and purity of the medicine. In addition, the high-speed production and new formulation method adapt to vasoactive intestinal peptide’s fragile nature.
NRx seeking EMA for aviptadil in the US
While NRx continues to seek Emergency Use Authorization in the US, the successful new formulation and production scaleup of ZYESAMI permits it to relaunch the Expanded Access and Right to Try campaigns. The programs are meant to COVID-19 patients at a high risk of dying and who have exhausted all other treatment choices the opportunity to try ZYESAMI on an experimental basis.
NRx scientific advisor Ricardi Panicuccci said, “We began this project a year ago, with 9 days of stability and an ability to manufacture about 100 doses of medicine each day. We learned through significant study and testing that the important biologic activity of this small peptide is accompanied by a fragile molecular structure that is destroyed by standard high-volume pharmaceutical manufacturing processes.”
