FDA Progress: Epinephrine Sublingual Film Under Review for Severe Allergic Reactions
The Food and Drug Administration (FDA) has recently taken a significant step forward by accepting the New Drug Application (NDA) for epinephrine sublingual film (brand name Anaphylm™). This innovative treatment is designed to address Type 1 allergic reactions, including the life-threatening condition known as anaphylaxis.
A Game-Changer for Allergy Management
Epinephrine sublingual film represents an investigational polymer matrix-based epinephrine prodrug product. The application is bolstered by an extensive clinical data package, which encompasses multiple studies, including a pharmacokinetics (PK) study conducted on healthy adults, a pediatric PK study, and additional supportive research.
Comprehensive Clinical Data Package
The NDA submission is supported by a robust array of evidence:
- Temperature Study: Assessing the film’s stability under varying conditions.
- Self-Administration Study: Evaluating ease of use for patients.
- Allergen Study: Understanding the film’s efficacy in real-world allergen exposure.
These studies lay the groundwork for understanding the potential efficacy of Anaphylm in real-life scenarios.
Key Findings from Phase 3 Pivotal Studies
The pivotal phase 3 PK study involved 64 participants who were randomly assigned to receive either the epinephrine sublingual film, Adrenalin (manual intramuscular injection), EpiPen, or Auvi-Q. The results were illuminating:
- Maximum Concentration (Cmax): Anaphylm achieved a geometric mean Cmax of 470 pg/mL, comparable to Auvi-Q and EpiPen with values of 521 pg/mL and 469 pg/mL, respectively.
- Time to Maximum Concentration (Tmax): The sublingual film reached Tmax in 12 minutes, significantly quicker than EpiPen’s 20 minutes, Auvi-Q’s 30 minutes, and Adrenalin’s 50 minutes.
Repeat Dosing Results
In a subsequent repeat dosing segment involving 36 participants, Anaphylm exhibited sustained plasma concentrations that exceeded or matched those of Adrenalin and EpiPen, except for one time point over the course of two hours. Notably, the median Tmax after the second dose was just 10 minutes.
Safety Profile
The safety profile of epinephrine sublingual film was also commendable, demonstrating excellent tolerability with no serious adverse events reported throughout both phases of the trial.
Pediatric Considerations: A Pivotal Study
A pivotal study targeted at the pediatric population evaluated the pharmacokinetics and safety of Anaphylm in 32 young patients aged 7 to 17 with a history of allergic reactions. Results mirrored those of adult studies, reinforcing the safety and efficacy of this revolutionary treatment for children.
Dan Barber, President and CEO of Aquestive, expressed optimism, stating, “Our clinical data demonstrates Anaphylm’s ability to rapidly deliver epinephrine absorption orally. With the FDA’s acceptance of our NDA, we’re one step closer to getting this life-saving innovation in the hands of the patients and caregivers who need it most.”
Innovative Packaging for an Essential Product
According to Aquestive, the packaging for epinephrine sublingual film is designed to be thin, small, and capable of withstanding weather excursions. If approved, it would stand as the first and only orally delivered epinephrine option for severe allergic reactions.
Looking Ahead
A target date of January 31, 2026 has been established by the Prescription Drug User Fee Act for a decision on this application.
By reimagining how life-saving epinephrine is administered, this development may redefine standards in allergy care.
[This article originally appeared on MPR.]
