RADNOR, PA — NRx Pharmaceuticals (Nasdaq: NRXP) announced that it recently filed a provisional composition of matter patent application with the US Patent and Trademark Office entitled “Stable, Buffer-free Compositions of Vasoactive Intestinal Peptide (VIP).” The provisional application describes compositions of vasoactive intestinal peptide, the synthetic form of which is aviptadil, that are both shelf-stable and biologically active when used to treat COVID-19 and other diseases.
There have been previous attempts to create stable forms of aviptadil for pharmaceutical use that include the use of various additives, such as buffers, mannitol, and sucrose. Those additives routinely compensate for lack of strict chemical controls in drug formulations. However, NRx was advised in late 2020 that such formulations lead to inactivation of the peptide and cannot be used in human treatment.
The current invention relies on specific approaches to controlling the chemical environment of VIP, an extremely delicate peptide, in order to maintain its stability without the use of such additives. The project was led by an industry-veteran development team that collectively has more than two centuries of drug formulation and development experience.
Prior to this invention, VIP could only be manufactured for human use in small batches with a shelf-life that expired after several weeks. The invention is significant to NRx’s drug development efforts because it provides a path to long-term shelf stability and a drug that can be included in national stockpiles. The patent filing also provides a path to inclusion in the FDA “orange book” of innovative drugs. Medicines that lack an orange book listing may be offered for sale by generic drug manufacturers after a statutory period that ranges from three to seven years. Orange book-listed medicines, on the other hand, may not be offered for sale by generic manufacturers for the life of the patent.
The inventions identified in the recently-filed patent have already been incorporated into the manufacture of ZYESAMI® (aviptadil) and were reviewed by the FDA as part of its review of ZYESAMI’s manufacturing process in September 2021. NRx anticipates that upon regulatory approval should safety and efficacy be demonstrated, ZYESAMI now has a path to drug release and innovative drug protection in the marketplace.
“In our previous guidance to investors, we advised that there were no filed patents protecting the manufacture of ZYESAMI. With the filing of this patent and the inventions described within, we at NRx believe we have a path to a long term commercial life for a stable and pharmaceutically active form of VIP as an innovative drug,” said Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals. “Although, for obvious reasons, our initial focus has been the use of VIP in lung disease caused by COVID-19, we are now considering potential use of ZYESAMI in non-COVID-related lung disease, liver disease, eye disease, and organ transplantation. We are deeply grateful to our partners at Nephron Pharmaceuticals for working with us and embracing the painstaking work required to bring a seventy-year-old dormant drug to life.”
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