Orexo AB's OX640, a powder-based nasal epinephrine formulation, has shown promising results in a clinical study evaluating its effectiveness in treating allergic reactions, including anaphylaxis. The study, designated OX640-002, demonstrated that the nasal spray achieved clinically relevant plasma levels of epinephrine more rapidly than a standard intramuscular injection, particularly in subjects experiencing allergic rhinitis.
The cross-over study involved 30 participants with and without allergic rhinitis, assessing the pharmacokinetic and pharmacodynamic effects of two doses of OX640 compared to an intramuscular epinephrine injection. One of the OX640 doses was administered during induced allergic rhinitis symptoms to simulate real-world conditions where patients might experience airway compromise.
Rapid Epinephrine Absorption
Topline data revealed that OX640 treatments led to mean epinephrine plasma levels associated with clinical efficacy faster than the intramuscular injection, with exposure levels dependent on the dose. Notably, epinephrine absorption from OX640 was significantly faster when subjects had allergic rhinitis symptoms, suggesting that the nasal formulation can provide rapid relief even when airways are compromised.
Pharmacodynamic Effects and Safety
OX640 formulations typically produced more pronounced increases in blood pressure and heart rate than the intramuscular injection, which are key effects for the treatment of anaphylaxis. The systemic safety profile was consistent with the known pharmacology of epinephrine, and local effects were transient and well-tolerated. The study reported no severe or serious adverse events.
Potential for Needle-Free Anaphylaxis Treatment
"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," said Robert Rönn, SVP and Head of R&D at Orexo. "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."
OX640 utilizes Orexo's proprietary AmorphOX® technology, which creates a powder formulation designed for rapid dissolution and drug exposure. This technology could offer a more convenient and user-friendly alternative to traditional epinephrine injections for individuals at risk of anaphylaxis.
