Aquestive Therapeutics' Anaphylm, a novel epinephrine film designed for sublingual administration, has shown promising results in alleviating symptoms of oral allergy syndrome (OAS) rapidly. Clinical trial data indicates that the film begins to ease OAS reaction symptoms in as little as two minutes, with complete symptom relief achieved in approximately 12 minutes on average.
Rapid Symptom Relief with Anaphylm
The study, prompted by the FDA, aimed to evaluate the impact of oral swelling on the absorption of Anaphylm. Researchers measured the time it took for epinephrine to reach its maximum concentration in the blood, comparing results with and without exposure to fruit allergens. The findings revealed no significant difference, suggesting that mouth swelling does not impede Anaphylm's absorption rates.
"We were ecstatic," said Daniel Barber, CEO and President of Aquestive Therapeutics. "What we really like about these results is they show the symptoms of edema [swelling] rapidly go away with our product."
The Anaphylm OAS study included 36 adults with allergies to foods such as pineapple, apple, kiwi, cherry, banana, or avocado. Participants experienced symptoms like swelling of the lips, throat, tongue, and cheek, as well as nasal congestion, after chewing and spitting out their allergenic fruit to trigger a reaction. Approximately 77% experienced moderate symptoms, and 17% experienced severe symptoms.
Consistent Absorption Rates
For comparison, the study also assessed Anaphylm's performance in participants without allergen exposure. Results indicated similar absorption rates in both scenarios, with a median Tmax of 12 minutes to reach maximum epinephrine concentration in the blood. This contrasts with the 50 minutes required to reach maximum concentration when epinephrine was administered via syringe without allergen exposure.
Steve Wargacki, PhD, Aquestive’s chief science officer, noted, "That’s a really nice sign the drug is doing exactly what you’d hope it would do."
Overcoming Oral Epinephrine Delivery Challenges
Historically, delivering epinephrine orally has been challenging due to vasoconstriction, which hinders absorption. Aquestive's scientists modified the epinephrine molecules in Anaphylm to bypass this issue, allowing them to pass through the mouth's mucosal membrane without triggering immediate vasoconstriction. Once the epinephrine enters the bloodstream, enzymes trigger the desired blood vessel constriction.
Next Steps for Anaphylm
Aquestive is planning an additional single-dose study in teens and older children before submitting Anaphylm for FDA approval. The company aims to submit their New Drug Application in early 2025, with a potential launch in early 2026 if approved. If approved, Anaphylm, containing a 12-milligram dose of epinephrine, will be available for adults and children weighing 66 pounds and more. A lower dosage film is also under development for smaller children weighing 30 to 66 pounds.
Convenient Alternative to Auto-Injectors
Anaphylm, about the size of a postage stamp, comes in a foil packet that can be easily carried in a pocket, wallet, or on the back of a mobile phone. The company believes this will address the issue of individuals not consistently carrying their epinephrine products.
"We believe the more alternative products in this space, the more patient choice there is … the better it is for patients. We think our product does that very nicely, and if approved by the FDA, ours will be the first and only oral product," Barber stated.
