Orexo has announced topline results from its OX640-002 PK/PD study of OX640 intranasal dry powder epinephrine in people with allergic rhinitis. According to the company, the study, which was initiated in October 2024, demonstrated that absorption of OX640 occurred significantly faster in subjects with allergic rhinitis symptoms than in those without rhinitis symptoms. Orexo also noted that OX640 caused greater increases in heart rate and blood pressure than injected epinephrine and that no serious adverse events were reported.
OX640 also produced clinically relevant plasma levels faster than intramuscular epinephrine, the company said. Orexo previously announced that the Phase 1 OX640-001 study demonstrated that OX640 could achieve epinephrine plasma levels comparable to EpiPen.
Orexo Senior VP and Head of R&D Robert Rönn commented, “We are pleased with the outcome of the study which further support the utility of our OX640 epinephrine nasal powder for treatment of anaphylaxis, even in case of allergic rhinitis symptoms. Importantly, the study results allow us to decide on the final commercial formulation and dose, which is critical to advance the project towards regulatory approval. The data further reinforces our view that OX640 has the potential to be a unique and differentiated needle-free epinephrine product.”
Read the Orexo press release
