Aquestive's Epinephrine Film Demonstrates Rapid Relief for Oral Allergy Syndrome

Aquestive Therapeutics查看公司主页' Anaphylm查看药品详情, a novel epinephrine查看药品详情 film designed for sublingual administration, has shown promising results in alleviating symptoms of oral allergy syndrome (搜索)搜索该疾病 (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查看药品详情. Researchers measured the time it took for epinephrine查看药品详情 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查看公司主页. "What we really like about these results is they show the symptoms of edema [swelling] rapidly go away with our product."

The Anaphylm查看药品详情 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查看药品详情'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查看药品详情 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查看药品详情 orally has been challenging due to vasoconstriction, which hinders absorption. Aquestive's scientists modified the epinephrine molecules in Anaphylm查看药品详情 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查看药品详情 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查看药品详情, 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查看药品详情, 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查看药品详情 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.