Aquestive Therapeutics Receives Positive FDA Feedback for Anaphylm™ (Epinephrine) Sublingual Film

Aquestive Therapeutics, Inc., a trailblazing pharmaceutical company dedicated to improving patients’ lives through innovative science and delivery technologies, has announced positive feedback from the U.S. Food and Drug Administration (FDA) regarding its planned NDA submission for Anaphylm™ (epinephrine) Sublingual Film. If approved, Anaphylm would be the first and only orally delivered epinephrine product for treating severe allergic reactions, including anaphylaxis.

Publish Date: 02-12-2024 Source: Aquestive Therapeutics, Inc.

Anaphylaxis is defined as a sudden and potentially life-threatening allergic reaction that affects the entire body. It occurs when a foreign substance triggers a response with specific IgE antibodies on mast cells and basophils in the blood. This interaction leads to the release of histamine and other chemicals, causing various symptoms such as muscle spasms, bronchospasm, swelling of mucous membranes, inflammation, and increased permeability of blood vessels. The symptoms of anaphylaxis can range from respiratory difficulties and severe hives to low blood pressure and swelling of the deeper layers of the skin. Despite extensive research, there is currently no single biomarker that definitively confirms an anaphylactic reaction. Further research is needed to identify biomarkers specific to different types of anaphylaxis, which would help determine severity, predict risks, and choose the most effective treatment for each patient. Various factors, including individual risk factors and co-factors, can influence the severity and onset of anaphylaxis. Identifying these factors is crucial for implementing preventive measures and reducing the likelihood of recurrence. Prompt recognition and treatment are vital in managing anaphylaxis, with adrenaline being the primary and immediate treatment. Long-term management involves identifying and avoiding triggers, understanding co-factors such as mast cell disorders, educating patients, parents, and caregivers, and reducing sensitivity to allergens through interventions like venom immunotherapy for those with Hymenoptera hypersensitivity.

The lifetime prevalence of anaphylaxis is estimated to be between 0.05% and 2% in the USA and around 3% in Europe.

However, the current Anaphylaxis treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Dexamethasone Oral, Epinephrine injection, PVX-108, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Anaphylaxis treatment. The key companies in the advanced development stage are Hamad Medical Corporation, American Regent, Inc., Aravax Pty Ltd, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Anaphylaxis to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2023 to 2033.

About Thelansis:

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