Orexo reports positive results for OX640 study in allergic rhinitis patients

In Uppsala, Sweden, Orexo AB recently unveiled promising outcomes from their clinical study, OX640-002, which assessed the effectiveness of their nasal epinephrine powder, OX640, for individuals with and without allergic rhinitis. This study is crucial as OX640 is developed to address severe allergic reactions, such as anaphylaxis, using the patented AmorphOX® technology.

The clinical trial was a crossover study involving 30 participants. It evaluated the pharmacokinetic and pharmacodynamic properties of epinephrine after administering two doses of OX640. Importantly, one dose was given during a period when the subjects exhibited allergic rhinitis symptoms, triggered by nasal allergens. This design allowed for a comparative analysis with a conventional intramuscular epinephrine injection.

Key findings from the study highlighted that OX640 could reach clinically relevant plasma levels of epinephrine more swiftly than the intramuscular injection. This rapid absorption was especially pronounced under conditions of allergic rhinitis, suggesting that OX640 can provide quick relief even when patients are experiencing airway symptoms. Additionally, OX640 demonstrated more significant increases in blood pressure and heart rate compared to the intramuscular alternative, crucial effects for managing anaphylaxis.

From a safety perspective, the systemic effects of OX640 were consistent with the known pharmacological profile of epinephrine. Local side effects were temporary and manageable, with no severe adverse events reported, underscoring the safety of the treatment.

Robert Rönn, who leads Research and Development at Orexo, expressed satisfaction with the study results. He emphasized that these findings validate the potential of OX640 as a needle-free solution for anaphylaxis, particularly valuable for those with concurrent allergic rhinitis. The data will guide the finalization of the commercial formulation and dosage, paving the way for regulatory approval.

Orexo AB, known for its innovative pharmaceutical solutions, operates out of Sweden and has established a strong market presence in the United States, particularly in treating opioid use disorder and related conditions. With 30 years of experience, Orexo continues to leverage proprietary technologies to develop products that meet significant medical needs. In 2023, the company reported net sales of SEK 639 million and employed 116 people.

The proprietary technology behind OX640, AmorphOX®, is noteworthy for its composition of drug particles combined with carrier materials, which results in a stable yet rapidly dissolving powder. This platform supports a wide range of active ingredients and has been validated across multiple clinical trials, demonstrating its ability to deliver fast and extensive drug exposure.

The OX640-002 study was conducted outside the allergy season, ensuring that subjects had no ongoing symptoms at the outset. It involved measuring epinephrine plasma levels, blood pressure, and heart rate post-administration of two OX640 doses and a 0.3 mg intramuscular injection. This rigorous design provided a comprehensive comparison of the nasal powder's efficacy and safety profile under different conditions.

The findings from this study were officially released on January 10, 2025, marking a significant milestone in Orexo's journey to bring a novel, effective treatment option to those suffering from severe allergic reactions.