Aquesta Therapeutics Announces Positive Data for Anaphylm™ Sublingual Epinephrine Film

Aquestive Therapeutics, Inc., a pharmaceutical company focused on improving patients' lives through innovative science and delivery technologies, has released promising topline pharmacokinetics (PK) data from the self-administration study of Anaphylm™ (epinephrine) Sublingual Film. Anaphylm is being developed as the first non-invasive, orally delivered epinephrine to treat severe allergic reactions, including anaphylaxis, pending FDA approval.

Daniel Barber, the President and CEO of Aquestive, emphasized the benefits of Anaphylm, highlighting its ease of use, portability, and rapid epinephrine absorption under various conditions. Barber noted that Anaphylm addresses real-world emergency scenarios where ideal administration might not be possible, contrasting it with traditional single-use medical devices. Anaphylm offers unique administration properties that enable the delivery of life-saving medication effectively.

The study, a single-dose, three-period, randomized crossover design, evaluated the PK and pharmacodynamics (PD) of Anaphylm when self-administered, administered by healthcare providers (HCPs), and compared to manual intramuscular injection of Adrenalin by HCPs. Key PK parameters included the maximum epinephrine concentration in plasma (Cmax) and exposure over time (AUC) in 36 healthy adult subjects. The results showed no statistical difference in PK parameters between self-administered and HCP-administered Anaphylm. The median time to maximum concentration (Tmax) was 15 minutes for both Anaphylm self-administered and HCP-administered arms, compared to 50 minutes for the Adrenalin IM HCP-administered arm.

Dr. Matthew Greenhawt, an anaphylaxis expert and member of Aquestive's Scientific Advisory Board, pointed out that managing severe allergic reactions can be chaotic for patients and caregivers. He suggested that an orally administered product like Anaphylm could be a significant advancement for the allergy community due to its ease of carry, administration, and rapid epinephrine delivery.

Aquestive's final supportive study, the Oral Allergy Syndrome (OAS) challenge study, is currently enrolling participants and is expected to conclude by the end of the third quarter or early fourth quarter of 2024. The company plans to request a pre-New Drug Application (NDA) meeting with the FDA before the end of the third quarter. Aquestive anticipates filing an NDA for Anaphylm late in the fourth quarter of 2024 or early in the first quarter of 2025, aiming for a full product launch by the end of 2025 or early 2026.

Anaphylaxis, a severe systemic hypersensitivity reaction, poses a significant health risk, affecting as many as 49 million people in the United States alone. The condition's lifetime prevalence in the U.S. is at least 5%, impacting over 16 million individuals. Annual direct costs of anaphylaxis are estimated at $1.2 billion, with significant expenditures on epinephrine and indirect costs. Hospital admissions for anaphylaxis have surged by 500-700% over the last 10-15 years. However, a considerable number of patients who have experienced anaphylaxis lack a prescription or access to an epinephrine auto-injector.

Currently, the standard treatment for anaphylaxis involves epinephrine injection, which can reverse severe symptoms such as skin rash, throat swelling, respiratory distress, gastrointestinal issues, and loss of consciousness. Anaphylm represents a potential breakthrough as a non-invasive, easy-to-use alternative that can be quickly administered without the need for needles.

Aquestive Therapeutics is dedicated to advancing orally administered products that deliver complex molecules, offering novel alternatives to conventional, invasive therapies. The company has a portfolio of five commercialized products and collaborates with other pharmaceutical firms to bring new molecules to market using its proprietary technologies, such as PharmFilm®. Aquestive is also focused on developing treatments for central nervous system disorders and severe allergic reactions, including anaphylaxis.