Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

A study demonstrated that oral physiological changes caused by 

 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.”

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

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.

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

American Academy of Allergy, Asthma & Immunology

A study investigated the impact of oral physiological changes due to allergen exposure on the pharmacokinetics and pharmacodynamics of Anaphylm in patients with Oral Allergy Syndrome (OAS). Conducted by Carl Kraus, MD, and his team, the phase 2 trial compared Anaphylm to intramuscular epinephrine. Results showed that Anaphylm was as effective, if not more, than epinephrine, with rapid symptom resolution. The study concluded that allergen-induced oral changes do not affect Anaphylm's pharmacokinetic or pharmacodynamic profiles, suggesting a potential model for evaluating new epinephrine technologies.

A study found that oral physiological changes from allergen exposure in Oral Allergy Syndrome do not alter Anaphylm’s pharmacokinetic or pharmacodynamic profiles.


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

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

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.