Aquestive Therapeutics announced positive topline data from their recent phase 2 study of Anaphylm™, a tiny film placed under the tongue to treat anaphylaxis.
The single-dose, five-period, randomized crossover study was designed to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of Anaphylm just after consuming normal water (hot, cold, and room temperature), lemon water, and baking soda water.
PK describes the concentration of a drug in body fluids over time resulting from administration of a certain drug dose, PD is the observed effect resulting from a certain drug concentration.
Previous studies have shown that Anaphylm’s PK and PD are comparable to those of traditional epinephrine auto-injectors.
Topline PK data from the study showed no statistically significant difference in PK results based on changes in temperature and pH. The most consumed beverages, such as soda, milk, coffee, and juice, have acidity between lemon water and normal water. While not statistically significant, alkaline substances like baking soda showed a somewhat higher absorption level than room-temperature water.
Said Daniel Barber, President and CEO of Aquestive:
The positive topline data from this study reinforce that Anaphylm has the potential to be seamlessly integrated into patients’ daily lives. 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. 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.
