Orexo’s Nasal Adrenaline Rescue Medication OX640 Enters Clinical Development

Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY) today announces it has successfully initiated the first explorative human clinical study (OX640-001) for OX640, an adrenaline rescue medication with nasal delivery. The study aims to determine the relative bioavailability and absorption characteristics of investigational OX640 formulations versus an intramuscular adrenaline injection in healthy volunteers.

Adrenaline is commonly used for the emergency treatment of allergic reactions, including anaphylaxis. First line treatments today are intramuscular auto-injector products. Since adrenaline is a very sensitive active ingredient that easily undergoes degradation, currently marketed injection products all contain antioxidant chemical additives to help reduce degradation. Despite these additives, and that these products require strictly controlled handling and storage, they still suffer from having limited shelf-life.

Orexo’s OX640 product is a nasal adrenaline formulation based on its proprietary drug delivery platform amorphOX®. Stability data generated so far for OX640 strongly indicates the potential for an adrenaline product with significantly improved stability versus today’s injection products, both in terms of allowed storage temperatures as well as shelf-life. These encouraging data has been obtained without the addition of any antioxidants.

In addition to offering allergic patients with a product that provides greater flexibility in terms of handling and storage, OX640 provides a less bulky, more convenient and needle-free alternative to auto-injectors.

Robert Rönn, SVP and Head of R&D at Orexo AB, said: “I am very proud that the team at Orexo has, once again, timely allowed us to reach this important milestone. Our nasal adrenaline formulation has the potential to provide allergic patients with a truly improved and differentiated product and we are looking forward to the study results later this year.”

The prevalence of allergic reactions, including anaphylaxis, is a global and growing health problem. The global market size today exceeds USD 2 billion and is expected to show continuous strong growth in the coming years.[1]
Nikolaj Sørensen, President and CEO at Orexo AB, said: “In the development of our rescue medication for overdoses, OX124, the aim was to develop a medicine that is not only faster than the existing alternatives, but also more powerful and with longer duration. Solving this equation led to the development of a novel and unique drug delivery platform, amorphOX®, which in exploratory studies has proven to be very scalable as it works with a broad scope of drugs. Our adrenaline project, OX640, is a very promising example capitalizing on this platform and which open new exciting opportunities that go beyond the treatment of mental illness and substance use disorders.”