Oral Allergy Syndrome Does Not Impact Anaphylm’s Pharmacokinetics or Efficacy

Carl Kraus, MD

Credit: Aquestive Therapeutics

A study demonstrated that oral physiological changes caused by allergen exposure in patients with Oral Allergy Syndrome do not modify the pharmacokinetic or pharmacodynamic profiles of Anaphylm.

Anaphylaxis often causes oral physiological changes, implicating upper respiratory, respiratory, digestive, cardiovascular, and skin processes.2 However, how do these physiological changes impact the effectiveness of medication?

Investigators sought to characterize the impact of oral physiological changes caused by anaphylaxis on the absorption, pharmacokinetics, pharmacodynamics, and time course of symptom resolution after Anaphylm administration. In their late-breaker presented at the 2025 American Academy of Allergy, Asthma, & Immunology (AAAAI) annual meeting in San Diego from February 28 – March 3, the team emphasized the importance of understanding the impact of these physiological changes on Anaphylm use, as this could inform potential conditions of use.

The team, led by Carl Kraus, MD, from Aquestive Therapeutics, conducted a phase 2, open-label randomized trial that included 2 parts and 3 treatments. The study compared the pharmacokinetics of Anaphylm to intramuscular epinephrine injection in adult patients with Oral Allergy Syndrome. The team assessed single and repeat doses of Anaphylm, both with and without an oral allergen challenge. The Verbal Rating Scale was used to measure symptoms.

At screening, 94% (34 of 36) of participants demonstrated moderate or severe symptoms after allergen exposure. A single dose of Anaphylm with oral allergen challenge was just as effective—or more effective than an intramuscular epinephrine injection across primary and secondary pharmacokinetic parameters. Furthermore, there were no statistically significant differences in pharmacokinetic parameters between patients who underwent oral allergen challenges and those who did not.

Moreover, the team observed a rapid symptom resolution with both intervention types. Symptom resolution occurred by 12 minutes compared to 74 minutes without intervention. Angioedema symptoms resolved by a mean of 5 minutes.

“This study demonstrates that oral physiological changes induced by allergen exposure in subjects with OAS do not alter the pharmacokinetic or pharmacodynamic profiles of Anaphylm,” investigators concluded. “A challenge model of OAS may serve as a potential tool to better understand the value of new epinephrine technologies that cannot be ethically or feasibly studied in anaphylaxis.”

References

1. Kraus, C, Wargacki, S, Berg, S, et al. Oral Anaphylm Symptom Intervention Study (OASIS). Journal of Allergy and Clinical Immunology, Volume 155, Issue 2, AB433

2. Reber LL, Hernandez JD, Galli SJ. The pathophysiology of anaphylaxis. J Allergy Clin Immunol. 2017 Aug;140(2):335-348. doi: 10.1016/j.jaci.2017.06.003. PMID: 28780941; PMCID: PMC5657389.