Orexo Announces Positive Topline Data for Nasal Epinephrine Powder OX640 in People with Allergic Rhinitis
Treatments with the investigational rescue medication achieved clinically effective epinephrine levels faster than intramuscular injection.
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An investigational powder-based nasal epinephrine rescue medication may be effective for the treatment of severe allergic reactions (including anaphylaxis) in people with allergic rhinitis.1
Swedish pharmaceutical company Orexo announced positive topline findings today from the OX640-002 clinical trial evaluating the performance of the company’s nasal rescue medication OX640 in patients with and without allergic rhinitis. The cross-over study involved 30 participants and assessed the absorption and pharmacodynamic effects of 2 doses of OX640, including 1 dose administered during active allergic rhinitis symptoms. A commercial intramuscular epinephrine injection was used for comparison.1
Key findings from the study include1:
- Rapid absorption: OX640 treatments achieved clinically effective plasma levels of epinephrine more rapidly than the intramuscular injection, with dose-dependent exposure levels.
- Enhanced absorption during allergic rhinitis: Absorption of OX640 was significantly faster when administered under allergic rhinitis conditions, supporting its rapid onset of action in patients with airway symptoms.
- Pharmacodynamic effects: The nasal powder formulation led to more pronounced increases in blood pressure and heart rate compared to intramuscular injection, both critical effects for anaphylaxis treatment.
Safety data indicated that systemic effects were consistent with the known pharmacology of epinephrine. Local effects were transient and well-tolerated, with no severe or serious adverse events reported, according to Orexo.
Allergic rhinitis affects between 10% and 30% of the global population and approximately 7.8% of US adults aged 18 years and older have allergic rhinitis, according to the American Academy of Allergy, Asthma, & Immunology.2 Symptoms range from mild nasal congestion to severe airway inflammation. For primary care physicians, who are often the first point of contact for patients experiencing anaphylaxis or seeking management for chronic allergic conditions, these results underscore the importance of having effective, easily administered treatment options.
“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,” Robert Rönn, senior vice president and head of research and development at Orexo, said in the press release.1 “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."
