Aquestive Therapeutics reports that its Anaphylm™ sublingual epinephrine film resolved allergen-related symptoms within five minutes in an oral allergen challenge study.

Traditional epinephrine delivery methods, such as intramuscular injections (IM) via autoinjectors like EPI or Jext pens, can present challenges for patients during severe allergic reactions. These devices require technique and can be intimidating or inconvenient, especially in high-stress situations. Additionally, many individuals with allergies may not consistently carry an epinephrine autoinjector or have access to one during unexpected reactions, such as a first-time occurrence.

As a result, there is a growing need for alternative delivery options that are easier to carry and administer while remaining effective. This is growing area of treatment research with recent advances as the First Nasal Spray for Treatment of Anaphylaxis is FDA-Approved for use in USA and from August EMA approved from EU also.

These study findings represent the completion of Aquestive's final adult supportive study for Anaphylm™ (AQST-109). Aquestive plans to submit its NDA in early 2025, with hopes to launch Anaphylm™ by 2026, pending FDA approval. Additional studies in children are also underway to expand its applications.

Aquestive describes Anaphylm™ as a polymer matrix-based epinephrine prodrug product candidate. About the postage stamp size, the lightweight sublingual film begins dissolving on contact and does not require any water or swallowing.

It comes in a package smaller than a credit card, so it can be carried in a pocket or wallet while withstanding exposure to weather, such as rain or sunlight.

Key Study Insights:

• Anaphylm™ begins to dissolve on contact and doesn't require water or swallowing.
• Complete symptom resolution occurred in a median time of 12 minutes, including single and repeat doses.
• Administration of Anaphylm™ provided symptom relief within as little as two minutes for some participants.

Study Design

The Oral Allergy Syndrome (OAS) challenge study was designed as a two-part investigation to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of Anaphylm™ in adults with allergen-induced oral physiological change. 

Part 1 of the study enrolled subjects with confirmed OAS into a three-period study with the following arms: Anaphylm™ with allergen exposure, Anaphylm™ without exposure, and IM epinephrine without exposure. 

Part 2 was an optional follow-up to Part 1. Six participants switched from single to repeat doses, and six switched from repeat to single doses.

Anaphylm was given with allergen exposure, while IM was given without exposure.

In the allergen exposure arms of Parts 1 and 2, subjects were exposed to a fruit they were allergic to, with symptoms recorded for their location, severity, and duration. There were no reports of difficulty administering Anaphylm to subjects in the study.

Results

The primary endpoints compared the PK of Anaphylm during allergen exposure to those of adrenaline IM injection without allergen exposure.

The OAS challenge study successfully met both primary and secondary endpoints. Anaphylm's PK results showed no significant differences between subjects with and without allergen exposure and remained consistent with profiles from the company's pivotal study in healthy subjects.

Anaphylm™ reached maximum plasma concentration (Tmax) within 12 minutes, significantly faster than IM epinephrine at 50 minutes.

Similarly, the maximum plasma concentration (Cmax) was comparable between Anaphylm administered with and without allergen exposure.

Anaphylm™ was well-tolerated, with only mild to moderate side effects that resolved without intervention, and no serious adverse events were reported.

For more information, view:

Aquestive Therapeutics Press release 

Aquestive Therapeutics Presentation 

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