Aquestive Therapeutics Announces Positive Topline Data from Anaphylm™ Sublingual Film Study

Aquestive Therapeutics, Inc., a pharmaceutical company focused on developing innovative medicines, has announced positive top-line pharmacokinetic (PK) data from their temperature and pH study of Anaphylm™ (epinephrine) Sublingual Film. Anaphylm is the company's first oral epinephrine prodrug aimed at treating severe allergic reactions, including anaphylaxis.

Daniel Barber, President & CEO of Aquestive, highlighted the importance of these findings, emphasizing that Anaphylm could become a practical, easy-to-use solution for people prone to severe allergic reactions. Barber cited a survey where all participants indicated they would not return home to retrieve an autoinjector if forgotten, underscoring the need for a more convenient epinephrine option. He believes Anaphylm could fill this gap, making it easier for patients to manage their condition.

The study involved a single-dose, five-period, randomized crossover design to compare the PK and pharmacodynamics (PD) of Anaphylm after the consumption of various liquids: hot, cold, and room temperature water, lemon water, and baking soda water. The study measured the maximum plasma concentration (Cmax) and the area under the curve (AUC) of epinephrine in 30 healthy adults. Results showed no significant difference in PK data due to liquid temperature and pH changes. Beverages such as soda, milk, coffee, and juice, which have acidity levels similar to lemon water, did not affect absorption significantly. However, alkaline substances like baking soda water showed a slightly higher absorption rate than room-temperature water.

The PK data showed the following Cmax and AUC 0-60min ratios in comparison to room temperature water:

- Cold water: 106% Cmax, 98% AUC
- Hot water: 104% Cmax, 107% AUC
- Lemon water: 98% Cmax, 99% AUC
- Baking soda water: 123% Cmax, 132% AUC

Eleanor Garrow-Holding, President & CEO of Food Allergy & Anaphylaxis Connection Team (FAACT), praised the study results, stating that they reinforce confidence in Anaphylm as a reliable rescue medication. She highlighted the importance of innovative treatments that can improve care and outcomes for patients experiencing severe allergic reactions.

Aquestive is also conducting additional supportive studies, including a self-administration study and an oral allergy syndrome (OAS) challenge study, both set to conclude by mid-2024. The company plans to undertake a pediatric study in the fourth quarter of 2024, with the goal of filing a New Drug Application (NDA) for Anaphylm soon after.

The positive results of the temperature and pH study, combined with ongoing and planned studies, position Aquestive to request a pre-NDA meeting with the FDA in the third quarter of 2024. The company remains committed to delivering Anaphylm as a novel solution to address unmet needs in the severe allergy community.

Anaphylaxis, a severe systemic hypersensitivity reaction, affects millions in the United States, with a significant percentage of those at risk lacking immediate access to epinephrine. Anaphylm offers a potential non-invasive, easy-to-carry alternative to traditional epinephrine autoinjectors, aiming to improve the quality of life and safety for those susceptible to severe allergic reactions.