Aquestive Therapeutics and Insignis Therapeutics are making strides in anaphylaxis treatment with their needle-free epinephrine products. Both companies recently announced positive feedback from the U.S. Food and Drug Administration (FDA) regarding their respective sublingual epinephrine delivery systems.
Aquestive Therapeutics' Anaphylm (epinephrine) Sublingual Film is on track for a New Drug Application (NDA) submission in the first quarter of 2025, according to the company. If approved, Anaphylm has the potential to be the first and only orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis.
FDA Feedback on Anaphylm
The FDA agreed with Aquestive’s planned NDA content and format, safety evaluation, and pediatric trial design. The agency also provided guidance on additional data views and emphasized pharmacokinetic sustainability for a single dose. Aquestive has commenced its single-dose pediatric trial in December 2024 across U.S. and Canadian sites. Daniel Barber, President and Chief Executive Officer of Aquestive, stated that bringing an orally delivered epinephrine product to market could be transformative for the 33 million Americans with food allergies.
Anaphylm: Features and Benefits
Anaphylm is a polymer matrix-based epinephrine prodrug product candidate, similar in size to a postage stamp and weighing less than an ounce. It dissolves on contact, requiring no water or swallowing. The packaging is designed to be compact and withstand weather excursions. The trade name Anaphylm for AQST-109 has been conditionally approved by the FDA.
Insignis Therapeutics' IN-001
Insignis Therapeutics also announced positive FDA feedback for its IN-001, a needle-free epinephrine sublingual spray for anaphylaxis. IN-001 is based on an FDA-approved epinephrine prodrug that enhances stability and absorption. The FDA granted IN-001 Fast Track designation in July 2024, potentially expediting its regulatory review.
Clinical Development of IN-001
Following a successful Phase I study, Insignis is planning PK/PD trials in healthy human subjects. If successful, these trials could lead to an NDA submission and potential FDA approval for the emergency treatment of severe allergic reactions. Mingbao Zhang, PhD, MBA, CEO of Insignis Therapeutics, highlighted IN-001 as a potentially life-saving, user-friendly alternative to injectable epinephrine.
Unique Formulation of IN-001
IN-001's formulation remains stable at temperatures as high as 140°F (60°C) and resists freezing down to -74°F (-59°C), making it a reliable treatment option in various climates. If approved, IN-001 could become the preferred needle-free solution for treating severe allergic reactions.
Addressing Anaphylaxis
Anaphylaxis is a severe, potentially life-threatening allergic reaction that can occur rapidly. Common triggers include foods, insect stings, medications, and latex. Immediate treatment, typically involving epinephrine administration, is crucial to reverse symptoms.
With hospital admissions for anaphylaxis having increased significantly in recent years, the availability of user-friendly alternatives to traditional epinephrine auto-injectors is crucial. These new sublingual options from Aquestive and Insignis represent a significant step forward in anaphylaxis treatment, potentially improving the lives of millions affected by severe allergies.
