OX640
Redefining emergency treatment for anaphylaxis
OX640 is Orexo’s innovative intranasal powder formulation of epinephrine, designed to provide rapid onset and reliable dosing for the treatment of severe allergic reactions, including anaphylaxis. By eliminating the need for auto-injectors, OX640 addresses key barriers such as needle phobia and complexity of use in emergency situations, offering a patient-friendly life-saving intervention alternative.
Substance
Powder-based epinephrine
Development phase
Clinical
Temperature stability1
≤0.3% degradation after 24 months2
Administration
Nasal powder
Leverage established manufacturing processes
Yes
Partnership
Seeking partnership for continued development and global commercialization
Clinical evidence demonstrating strong performance
OX640 has delivered highly promising results in two clinical studies. In a randomized, open-label crossover study3, OX640 demonstrated rapid and extensive absorption of epinephrine, achieving clinically relevant plasma levels comparable to, or exceeding, those of intramuscular injection. Pharmacodynamic effects on blood pressure and heart rate were consistent with effective treatment of anaphylaxis, and onset of action was rapid, even in patients with allergic rhinitis. Across studies, OX640 was well tolerated, with no serious adverse events reported and only mild, expected side effects. These findings confirm the potential of OX640 as a differentiated, needlefree emergency treatment for anaphylaxis.
Unlocking differentiation through technology
OX640 delivers superior stability compared to traditional auto-injectors, overcoming storage limitations and reducing cold-chain dependency. Built on Orexo’s proprietary AmorphOX® platform, this technology enables a preservative-free formulation that is easy to store, transport, and administer: all critical advantages for patients and healthcare systems.
Looking ahead
Anaphylaxis treatment represents a well-established but underserved market, where ease of use and reliability are paramount. OX640 positions Orexo to capture a significant market share by addressing unmet needs in emergency care. The company is continuing to advance OX640 toward pivotal clinical trials and regulatory submissions, supported by its fully integrated capabilities, from rapid feasibility and in-house manufacturing to FDA-inspected supply chain and regulatory expertise. Orexo is seeking a partnership for continued development and commercialization.
Clinical study
Nasal epinephrine AmorphOX powder vs injection products
Findings: In the second clinical study, OX640-002, which included patients diagnosed with allergic rhinitis, OX640 demonstrated prompt absorption and maintained epinephrine concentrations under conditions of allergic rhinitis.
- Chemical degradation after accelerated stability studies in 40°C/75% RH.
- Dose scaled data.
- Crossover study comparison (Study EPI-15, FDA AC Briefing book).
