Orexo Launches New OX640 Clinical Trial in People with Allergic Rhinitis

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Orexo announced the first participants have been dosed with OX640, an intranasal rescue medication for severe allergic reactions (including anaphylaxis) with powder-based epinephrine, in a new study in people with allergic rhinitis.¹

The study, OX640-002, will be completed in 2024, with results expected in early 2025, according to an October 25, 2024, press release.¹

Orexo, a Swedish pharmaceutical company, is advancing the development of OX640 following positive results from the phase 1 clinical study OX640-001. The results showed that OX640 achieved epinephrine absorption and effects on blood pressure and heart rate comparable to an intramuscular epinephrine auto-injector.²

In OX640-002, researchers will investigate epinephrine absorption from OX640 among individuals with and without allergic symptoms in the nose. Because patients experiencing anaphylaxis may also have allergic rhinitis, understanding epinephrine absorption from the powder formulation under these conditions is crucial.¹

“Anaphylaxis is a serious and life-threatening condition, making it essential to ensure that OX640 remains effective even in the presence of nasal allergic symptoms. The study addresses key development and regulatory requirements and is an important step in advancing the project towards regulatory approval,” Robert Rönn, senior vice president and head of research and development at Orexo, said in the press release.¹

OX640-002 is a 4-period crossover study involving 30 people with allergic rhinitis. Participants will receive OX640 after a small dose of allergen is sprayed into the nose to induce anaphylaxis. This will be compared with epinephrine absorption from OX640 without the allergen as well as a commercial intramuscular epinephrine product. One period will also assess dose proportionality of OX640. In addition to epinephrine absorption, the study will measure effects on blood pressure and heart rate to understand the impact of OX640 in case of an allergic reaction.¹

OX640 utilizes Orexo’s AmorphOX drug delivery platform, which is designed to provide rapid systemic drug absorption after nasal administration and offer physical and chemical stability. It has the potential to provide a needle-free, convenient, and rapid-acting allergy rescue product with long shelf life and flexible storage, according to the press release.¹

References:

1. Orexo initiates new study of OX640 in participants with allergic rhinitis. News release. Orexo AB. October 25, 2024. Accessed October 25, 2025. https://orexo.com/media/detail?slug=orexo-initiates-new-study-of-ox640-in-participants-with-allergic-rhinitis
2. Orexo announces positive data from phase 1 clinical study for OX640 - a nasal epinephrine rescue medication for allergic reactions. News release. Orexo AB. October 11, 2022. Accessed October 25, 2024. https://orexo.com/media/detail?slug=orexo-announces-positive-data-from-phase-1-clinical-study-for-ox640-a-nasal-epinephrine-rescue-medication-for-allergic-reactions-a909b21d