Orexo has initiated a new pharmaceutical development project, OX640, a nasal adrenaline product for the emergency treatment of allergic reactions.
Adrenaline is commonly used for the emergency treatment of allergic reactions, including anaphylaxis, which is a global and growing health problem. The market is currently dominated by the use of auto-injectors for intramuscular or subcutaneous administration of injection solutions of adrenaline, although new delivery alternatives are under development.
Adrenaline is a very unstable active ingredient sensitive to chemical degradation, which is the reason why today’s commercial adrenaline products have limited shelf-life with restrictive storage conditions, states the company.
“OX640 has the potential to transform the adrenaline market offering nasal delivery and less restricted handling and storage requirements.”
“Our recently announced amorphOX platform has allowed us to initiate the development of a differentiated nasal adrenaline product with significant commercial potential. Data generated so far indicates we can develop a product with true and meaningful improvements of currently marketed products on a global market. OX640 has the potential to transform the adrenaline market offering nasal delivery and less restricted handling and storage requirements. I am looking forward to the continued development of OX640 and to explore potential partnerships in development and commercialization,” says Nikolaj Sørensen, President and CEO of Orexo.
OX640 is based on Orexo’s drug delivery platform amorphOX, and shows promising chemical and physical stability data, states the company. In addition to providing allergic patients with a more convenient, needle-free alternative to auto-injectors currently on the market, an adrenaline product that provides greater flexibility in relation to how it can be handled and stored should provide significant benefits to patients and healthcare systems, ensuring the correct adrenaline dose is available when needed.
Explore opportunities for development- and commercialization partnerships during 2022
Orexo has consulted with the US Food & Drug Administration on the development of OX640 and on the basis of their feedback outlined a development pathway. Orexo is currently optimizing the OX640 formulation and expects to perform a first explorative human clinical pharmacokinetic study in the second half of 2022. The results of the study are decisive for the final development plan and timeline. Furthermore, Orexo will be able to leverage investments and learnings made from the OX124 and OX125 projects (overdose rescue medications) in the continued development and future commercial manufacturing of OX640.
Orexo will consider the right partnership strategy for the product, but will explore opportunities for development- and commercialization partnerships during 2022.
Photo of Nikolaj Sørensen: Orexo