Sublingual Epinephrine Film Promptly Resolves Symptoms in Patients With Oral Allergy Syndrome

Sublingual epinephrine film (Anaphylm; Aquestive Therapeutics) met the primary and secondary end points of a trial evaluating its effectiveness in treating patients with oral allergy syndrome (OAS), with the drug rapidly resolving symptoms and being well-tolerated among trial enrollees, according to a news release from Aquestive Therapeutics.¹

Allergies to food such as fruits can be dangerous and cause allergic reactions. | Image Credit: © zinkevych | stock.adobe.com

According to the trial results released by Aquestive, the median time to complete symptom resolution following the administration of Anaphylm was 12 minutes, faster than the median time to symptom resolution during the screening process, which was 74 minutes. In some patients, symptoms began resolving as early as 2 minutes after treatment; 50% of all symptoms across all subjects were resolved by 5 minutes.¹

Importantly, any instances of symptomatic swelling were resolved completely in 5 minutes following Anaphylm administration. In addition, trial end points were successfully met with no major differences between pharmacokinetics results in subjects with and without allergen profiles. These safety results were similar to the safety profiles observed in the pivotal trial that previously took place in healthy subjects, with all adverse events characterized as mild or moderate and resolving themselves without intervention.^1,2

“Symptom relief is the most real-world scenario whereby subjects know their rescue product is working,” Jay Lieberman, MD, chair of the annual meeting program for the American College of Allergy, Asthma, and Immunology, said in the news release. “I am reassured by the speed of symptom relief seen in the OAS Study and by the continued and consistent rapid absorption profile of Anaphylm.”¹

Anaphylm, a polymer matrix-based epinephrine product, is administered under the tongue and dissolves on contact, weighing less than an ounce and designed to discreetly fit in the pocket of an individual. The OAS challenge study was imagined as a 2-pronged investigation to evaluate the pharmacokinetics and pharmacodynamics.¹

In both parts of the trial, patients were exposed to fruit they were known to be allergic to and their symptoms were documented for severity, location, and duration. Tongue, lip, cheek, and/or throat swelling was reported in 25% of participants upon this exposure, with 94% of subjects being categorized as having moderate or severe symptoms.¹

Regarding plasma concentration, the time to maximum plasma concentration (Tmax) remained at 12 minutes in individuals both with and without allergen exposure following a dose of Anaphylm, according to the news release. Furthermore, maximum plasma concentration was comparable between Anaphylm administered with and without exposure.¹

The completion of the trial marks the final adult study in the Anaphylm development program, prior to a potential new drug application (NDA) being submitted to the FDA for the medication. Following the release of their pivotal trial results in March, Aquestive met with FDA officials to address concerns surrounding Anaphylm raised in a prior meeting.^1,2

FDA officials recommended that Aquestlive begin pediatric studies following the completion of their remaining adult studies. A pre-NDA meeting is expected at some point during the latter portion of 2024, with the goal of submitting an NDA by the first quarter of 2025.²

"We are extremely pleased with the positive results from our OAS challenge study, which further validate Anaphylm's potential as a game-changing treatment option for severe allergic reactions, including anaphylaxis, if approved by the FDA,” Daniel Barber, president and CEOof Aquestlive, said in the news release.¹

REFERENCES

1. Aquestive. Aquestive Therapeutics announces positive topline results from oral allergy syndrome (OAS) challenge study for Anaphylm (epinephrine) sublingual film. GlobeNewsWire. Released October 24, 2024. Accessed October 28, 2024. https://www.globenewswire.com/en/news-release/2024/10/24/2968669/0/en/Aquestive-Therapeutics-Announces-Positive-Topline-Results-from-Oral-Allergy-Syndrome-OAS-Challenge-Study-for-Anaphylm-epinephrine-Sublingual-Film.html

2. Aquestive. Aquestive Therapeutics announces pivotal study for anaphylm (epinephrine) sublingual film successfully meets primary and secondary endpoints and provides clinical development update following FDA meeting. News Release. Released March 14, 2024. Accessed October 28, 2024. https://aquestive.com/aquestive-therapeutics-announces-pivotal-study-for-anaphylm-epinephrine-sublingual-film-successfully-meets-primary-and-secondary-endpoints-and-provides-clinical-development-update-following/