In This Article:
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OX640 is a nasal rescue medication with powder-based epinephrine for the treatment of allergic reactions (incl. anaphylaxis) and is based on the proprietary AmorphOX® technology.
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The clinical study, OX640-002, evaluated both pharmacokinetic and pharmacodynamic effects of OX640 in subjects with and without allergic rhinitis.
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OX640 treatments achieved clinically relevant plasma levels of epinephrine more rapidly than the intramuscular reference product.
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Absorption from OX640 under allergic rhinitis conditions was significantly faster than under normal conditions, supporting rapid onset of effect also in patients with airway symptoms.
UPPSALA, Sweden, Jan. 10, 2025 /PRNewswire/ -- Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today announces positive topline results from the clinical study OX640-002. The study evaluated the performance in subjects with and without allergic rhinitis when treated with Orexo´s nasal rescue medication including powder-based epinephrine, OX640.
The study was a cross-over study in 30 subjects assessing absorption and pharmacodynamic effects of epinephrine from two doses of OX640, with one of the doses also administered during ongoing allergic rhinitis symptoms. Exposure was compared to a commercial intramuscular injection.
Topline data analysis demonstrates that OX640 treatments achieved mean epinephrine plasma levels associated with clinical efficacy more rapidly than the intramuscular injection, with dose-dependent exposure levels. Absorption under allergic rhinitis conditions was significantly faster than under normal conditions, supporting rapid onset of effect also in patients with significant airway symptoms. OX640 formulations typically produced more pronounced increases in blood pressure and heart rate than the intramuscular injection, which are key effects for treatment of anaphylaxis.
Systemic safety was in line with the known pharmacology of epinephrine and local effects were transient and tolerated. There were no severe or serious adverse events.
Robert Rönn, SVP and Head of R&D, said: "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."
