Aquestive Therapeutics Epinephrine Sublingual Film Completes Temperature/pH Study

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Aquestive Therapeutics has reported positive topline findings from their temperature/pH study of epinephrine sublingual film (Anaphylm).

Announced on June 25, 2024, Aquestive Therapeutics noted the company remains on track to complete supportive clinical studies, expects to request pre-NDA meeting with FDA in the third quarter 2024, and anticipates filing a New Drug Application following the completion of its ongoing pediatric study.

“The positive topline data from this study reinforce that Anaphylm has the potential to be seamlessly integrated into patients’ daily lives,” said Daniel Barber, President & Chief Executive Officer of Aquestive. “A recent independently conducted survey reported that 100% of patients and caregivers who participated in the survey indicated they would not return home to retrieve an autoinjector, if forgotten. Breaking this concerning cycle of not carrying epinephrine, the only first-line treatment for anaphylaxis, requires a product that is easy to remember, easy to carry, and easy to use even after consumption of a beverage or food.

Outside of insulin and diabetes, agents and conditions have developed the same level of name associations as epinephrine and allergy. Dating back to the 1980s, the EpiPen has become synonymous with the treatment of allegoric reactions and, in 2018, the FDA approved the first generic version. However, the injectable version of this product is not leaves many patients with a desire for additional options and clinical programs have been launched to explore different administration methods, including nasal spray, powders, and sublingual film.

A single-dose, five-period, randomized crossover study, the trial was designed to assess the pharmacokinetic and pharmacodynamics of epinephrine sublingual film after consuming normal water at hold, cold, room temperature, lemon water, and baking soda water. The primary pharmacokinetic parameters of interest for the trial were the amount of epinephrine measured in plasma (Cmax) and exposure, or the area under the curve (AUC), at various times after dosing, in 30 healthy adult subjects.

According to Aquestive Therapeutics, results of the trial indicated there were no statistically significant difference in PK results based on changes in temperature and pH. Although it failed to reach the threshold for statistical significance, alkaline substance, such as baking soda, exhibited a greater absorption level than room-temperature water

As of June 25, 2024, the company’s remaining studies, which include the self-administration study and the oral allergy syndrome challenge study are all underway. If approved by the US FDA, epinephrine sublingual film would become the first and only non-invasive, orally delivered epinephrine for the treatment of severe life-threatening allergic reactions, including anaphylaxis.

“We believe Anaphylm possesses these essential attributes and has the potential to transform the lives of people at risk for severe and life-threatening allergic reactions, if approved by the FDA,” Barber added.

References:

Aquestive Therapeutics. Aquestive Therapeutics reports positive topline data from temperature / ph study of AnaphylmTM (epinephrine) sublingual film. Aquestive Therapeutics. June 25, 2024. Accessed June 26, 2024. https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-reports-positive-topline-data-temperature.

Lieberman JA, Oppenheimer J, Hernandez-Trujillo VP, Blaiss MS. Innovations in the treatment of anaphylaxis: A review of recent data. Ann Allergy Asthma Immunol. 2023;131(2):185-193.e10. doi:10.1016/j.anai.2023.05.033