San Diego,CA – A notable study unveiled at the 2025 American Academy of Allergy,Asthma,& Immunology (AAAAI) Annual Meeting demonstrates that Anaphylm,a new epinephrine formulation,remains effective even when patients experience oral physiological changes due to allergen exposure. The research, spearheaded by Carl Kraus, MD, from Aquestive Therapeutics, challenges previous assumptions regarding the impact of oral allergic syndrome (OAS) on drug absorption and efficacy during anaphylaxis. The findings were presented at the conference held from February 28 to March 3 in San Diego.

Anaphylaxis,a severe and potentially life-threatening allergic reaction,often presents with a range of physiological changes affecting various bodily systems. These changes can involve the upper respiratory system, breathing, digestion, cardiovascular function, and skin. Understanding how these physiological shifts influence the effectiveness of medications like epinephrine is crucial for optimizing treatment strategies.

study Design and Methodology

The study, a phase 2 randomized, open-label trial, was designed to evaluate the impact of oral physiological changes caused by anaphylaxis on the absorption, pharmacokinetics, and pharmacodynamics of Anaphylm. Researchers also examined the time it took for symptoms to resolve after administering Anaphylm. The trial compared Anaphylm’s pharmacokinetic profile to that of intramuscular epinephrine injection in adult patients diagnosed with oral allergic syndrome. The study involved three treatments and assessed both single and recurrent doses of Anaphylm, administered with and without oral allergen challenges. Symptom severity was measured using a verbal ranking scale.

Carl Kraus, MD, and his team emphasized the importance of this research, stating that understanding the impact of physiological changes on anaphylaxis treatment can inform the potential for use conditions and improve patient outcomes. The study meticulously examined how Anaphylm performs under varying conditions, providing valuable insights into its reliability and effectiveness.

Key Findings: Anaphylm’s Consistent Performance

The study revealed compelling results regarding Anaphylm’s performance. A meaningful majority, 94% (34 of 36), of participants exhibited moderate or severe symptoms following allergen exposure during the screening process.However, the management of a single dose of Anaphylm with oral allergen challenges proved to be equally effective, and in some cases, even more effective, than intramuscular epinephrine injection across primary and secondary pharmacokinetic parameters. Importantly, the study found no statistically significant difference in pharmacokinetic parameters between patients who underwent oral allergen challenges and those who did not.

These findings suggest that Anaphylm’s effectiveness is not compromised by the oral physiological changes associated with allergic reactions. This consistency is a critical advantage, ensuring that patients receive the necessary treatment irrespective of the severity of their oral allergy symptoms.

Rapid Symptom Resolution Observed

In addition to demonstrating consistent pharmacokinetic performance, the study also highlighted the rapid symptom resolution achieved with both Anaphylm and intramuscular epinephrine interventions. Symptom resolution occurred in an average of 12 minutes with intervention, compared to a considerably longer 74 minutes without intervention. Moreover,angioedema symptoms,characterized by swelling beneath the skin,resolved in an average of just 5 minutes.

These rapid resolution times underscore the potential of Anaphylm and intramuscular epinephrine to quickly alleviate the distressing and potentially hazardous symptoms of anaphylaxis,providing patients with timely relief and improving overall outcomes.

Researcher’s Conclusion

Dr. Kraus and his team concluded:

This study shows that oral physiological changes caused by allergen exposure to the subject with OA do not change the pharmacokinetic or pharmacodynamic profiles.

Carl Kraus, MD, Aquestive Therapeutics

They further noted:

The OAS challenge model can function as a potential tool to better understand the value of new epinephrine technology that cannot be learned ethically or decent in anaphylactic.

Carl Kraus, MD, Aquestive Therapeutics

This conclusion highlights the robustness of anaphylm and suggests that the oral allergic syndrome challenge model can be a valuable tool for future research and advancement of epinephrine-based therapies.

Implications and Future Directions

The findings from this study have significant implications for the treatment of anaphylaxis in patients with oral allergic syndrome. The consistent effectiveness of Anaphylm, even in the presence of oral physiological changes, provides clinicians with a reliable treatment option. Moreover, the rapid symptom resolution observed with Anaphylm underscores its potential to quickly alleviate the distressing and potentially life-threatening symptoms of anaphylaxis.

Future research may focus on further refining the oral allergic syndrome challenge model and exploring the potential of Anaphylm in diverse patient populations and clinical settings. These efforts will contribute to a deeper understanding of anaphylaxis and the development of more effective treatment strategies.

Anaphylaxis Breakthrough: Anaphylm’s Promise in Oral Allergy Syndrome

Imagine a world where a severe allergic reaction doesn’t mean a race against time for life-saving treatment. That’s the potential Anaphylm offers.

Dr. Anya Sharma, a leading allergist and immunologist, recently discussed the importance of the Anaphylm study, presented at the AAAAI Annual Meeting, for patients suffering from anaphylaxis, specifically those with Oral Allergy Syndrome (OAS).

According to Dr. sharma, “The Anaphylm study indeed represents a significant leap forward in managing anaphylaxis, notably in the challenging context of OAS. For patients experiencing OAS,the simultaneous occurrence of oral physiological changes during an allergic reaction has raised concerns about the efficacy of existing epinephrine treatments.This study directly addresses those concerns.”

She emphasized, “The key finding is that Anaphylm maintains its effectiveness even when patients are experiencing the physiological changes associated with OAS. this is a remarkable advancement that promises more reliable and effective treatment for this vulnerable patient population. This is crucial as the effectiveness of previous epinephrine treatments has frequently enough been uncertain under those conditions.”

understanding the Challenges of OAS and Anaphylaxis

Dr. Sharma elaborated on the specific challenges that OAS presents in the context of anaphylaxis management, stating, “Anaphylaxis is a life-threatening allergic reaction characterized by a cascade of physiological events affecting multiple organ systems—respiratory, cardiovascular, gastrointestinal, and dermatological. In patients with OAS, wich is triggered by ingesting certain allergens, the initial reaction occurs in the mouth and upper digestive tract.These oral and gastrointestinal symptoms — swelling, itching, and difficulty swallowing — can already compromise airway function and absorption of medication, including current epinephrine therapies.This complicates the treatment of subsequent anaphylactic symptoms, as even if the patient can successfully self-administer epinephrine, its absorption may be impaired due to the physiological changes associated with the OAS reaction.Anaphylm’s ability to function effectively even in these circumstances shows a significant advancement in existing treatment options.”

Anaphylm: A Game Changer in Anaphylaxis Treatment

When asked about what makes Anaphylm different from conventional intramuscular epinephrine injections, Dr. Sharma explained, “Traditional intramuscular epinephrine injections, while effective, rely on proper injection technique and can be challenging for self-governance during a severe reaction. absorption can also be affected under specific conditions and a rapid response to treatment is necessary. anaphylm, conversely, offers a novel formulation designed to overcome these limitations. The study demonstrates that Anaphylm provides consistent pharmacokinetic and pharmacodynamic profiles, regardless of the presence or absence of OAS-associated physiological changes. This is crucial as it provides a more reliable outcome. This consistent performance is a pivotal factor in enhancing the speed and reliability of anaphylaxis treatment.”

Implications for Clinical Practice and Future Research

Regarding the broader implications of this research for clinical practice and future directions in the field of allergy and immunology, Dr. Sharma stated, “The clinical implications are profound. Anaphylm offers a potential solution to a significant unmet need in treating anaphylaxis in the OAS population. By resolving the doubts surrounding the impact of OAS on epinephrine absorption and efficacy, we have a more confident avenue to better manage severe allergic reactions. Future research should focus on expanding trials to broader and more diverse patient populations, analyzing long-term efficacy and safety profiles, and exploring additional improvements in delivery methods. The study itself suggests a further refinement of the OAS challenge model for future studies—this could greatly streamline future work in this space. We can also look at the cost-effectiveness models of different treatments, and compare them with Anaphylm, to establish the overall value.”

Dr. Sharma concluded by encouraging readers to consider how this research can benefit their lives and those around them, and to share their thoughts and opinions.