A groundbreaking phase 2 clinical trial has revealed that Anaphylm's effectiveness remains uncompromised by oral physiological changes associated with Oral Allergy Syndrome (OAS), marking a significant advancement in anaphylaxis treatment options.
The open-label randomized trial, spearheaded by Dr. Carl Kraus of Aquestive Therapeutics, compared Anaphylm's pharmacokinetics with traditional intramuscular epinephrine injections in adult patients with OAS. The study specifically examined both single and repeat doses of Anaphylm, with and without oral allergen challenges.
Clinical Efficacy and Response Times
The trial demonstrated remarkable efficacy, with Anaphylm performing equally or more effectively than intramuscular epinephrine injections across all primary and secondary pharmacokinetic parameters. Notably, patients experienced symptom resolution within 12 minutes of Anaphylm administration, compared to 74 minutes without intervention. Particularly impressive was the resolution of angioedema symptoms, which occurred within a mean of 5 minutes.
Study Population and Design
The research included a robust patient population, with 94% of participants (34 out of 36) exhibiting moderate to severe symptoms following allergen exposure at screening. The study utilized the Verbal Rating Scale to measure symptom severity and response to treatment.
Physiological Impact Assessment
A key finding was that oral physiological changes triggered by anaphylaxis - which typically affect upper respiratory, digestive, cardiovascular, and skin processes - did not significantly alter Anaphylm's pharmacokinetic or pharmacodynamic profiles. No statistically significant differences were observed in pharmacokinetic parameters between patients who underwent oral allergen challenges and those who did not.
Research Implications
This study's findings carry substantial implications for anaphylaxis management. Dr. Kraus and his team suggest that their OAS challenge model could serve as a valuable tool for evaluating new epinephrine technologies that might otherwise be difficult to study in actual anaphylaxis cases due to ethical and feasibility constraints.
The research, presented at the 2025 American Academy of Allergy, Asthma, & Immunology (AAAAI) annual meeting in San Diego, provides crucial validation for Anaphylm's potential role in treating severe allergic reactions, even in the presence of oral physiological complications.
