Aquestive's Sublingual Epinephrine Film, Anaphylm, Nears NDA Submission for Anaphylaxis Treatment
Key Insights
Aquestive Therapeutics anticipates submitting a New Drug Application (NDA) for Anaphylm, a sublingual epinephrine film, to the FDA in the first quarter of 2025.
Anaphylm aims to provide a needle-free, device-free oral option for epinephrine delivery, potentially improving accessibility and ease of use for patients at risk of anaphylaxis (search).
Clinical data indicates Anaphylm's epinephrine absorption is comparable to autoinjectors like EpiPen, with a faster time to maximum concentration (Tmax).
Aquestive Therapeutics is advancing its Anaphylm sublingual epinephrine film for treating anaphylaxis (search), with plans to submit a New Drug Application (NDA) to the FDA in early 2025. This innovative approach seeks to provide a more accessible and convenient alternative to traditional epinephrine injections and nasal sprays, addressing critical unmet needs in anaphylaxis management.
Addressing Unmet Needs in Anaphylaxis Treatment
Anaphylaxis (search), a severe and potentially life-threatening allergic reaction, affects as many as 40 million people in the U.S. While epinephrine is a life-saving treatment, studies reveal that many patients do not have it readily available during anaphylactic episodes. Anaphylm aims to overcome barriers such as fear of needles, device usage errors, and the failure to carry epinephrine, offering a user-friendly solution for prompt intervention.
How Anaphylm Works
Anaphylm utilizes Aquestive’s PharmFilm technology to deliver a novel prodrug of epinephrine sublingually. The film, about the size of a postage stamp, dissolves on contact with saliva, delivering epinephrine without the need for water or swallowing. This needle-free, device-free approach simplifies administration and enhances portability, fitting easily into a purse or wallet.
Clinical Data and Performance
Clinical data has demonstrated that Anaphylm's epinephrine absorption is comparable to leading autoinjectors like EpiPen, with a faster time to maximum concentration (Tmax). According to Dan Barber, CEO of Aquestive Therapeutics, Anaphylm has the potential to be the first noninvasive, orally delivered epinephrine product candidate to demonstrate clinical results that are comparable to autoinjectors. The temperature/pH study data reinforce that Anaphylm has the potential to be seamlessly integrated into patients’ daily lives.
Advantages Over Existing Methods
Unlike traditional epinephrine auto-injectors, which are largely water-based and susceptible to degradation under varying temperature conditions, Anaphylm contains only about 2% water. This low water content potentially enhances its stability and durability in real-world conditions, reducing concerns about storage and effectiveness. Its simple, oral administration alleviates fears associated with traditional auto-injectors, which in turn, helps prevent administration hesitancy and possible improper administration and suboptimal dosing.
Next Steps and Regulatory Pathway
Aquestive has completed two of the three supportive studies required for engaging the FDA in a pre-NDA meeting. The remaining study, an oral allergy syndrome challenge study, is expected to be completed soon. Following a successful Type C meeting with the FDA, Aquestive anticipates submitting an NDA in the first quarter of 2025, with a potential product launch in late 2025 or early 2026, pending FDA approval.
Anaphylm represents a significant advancement in anaphylaxis (search) treatment, offering a convenient, needle-free alternative that addresses critical barriers to epinephrine access and administration. If approved, it has the potential to transform the management of severe allergic reactions and improve outcomes for patients at risk of anaphylaxis.