Anaphylaxis is a sudden and potentially fatal allergic reaction, affecting approximately 1.6 % of the population over their lifetime—making accessible and prompt treatment a critical priority in public health. Currently, epinephrine injections remain the only proven lifesaving intervention for anaphylaxis; however, many patients delay or avoid use due to challenges such as needle fear or limited accessibility. Developing a non‑invasive alternative could overcome these barriers and significantly improve the speed and reach of life‑saving treatment.

The goal of the project “Needle Free Treatment for Anaphylaxis/Neinvazivní léčba anafylaxe” (TQ08000002) is to develop a prototype intranasal formulation that ensures sufficient plasma concentrations of epinephrine for the non-invasive treatment of anaphylaxis. Project activities include formulation optimization, verification of stability through accelerated stability studies, efficacy evaluation in a preclinical animal model, and preparation for clinical trials along with the development of regulatory documentation. ReForm Therapeutics CZ is partnering with the Veterinary Research Institute to deliver this solution. This project aims to support the development of intranasally administered epinephrine as a viable alternative to injectable forms, with enhanced accessibility and user-friendliness. The output of the project is a prototype intranasal epinephrine formulation that will subsequently undergo testing in clinical trials. This prototype represents a novel, needle-free approach to deliver epinephrine via nasal administration, offering significant potential advantages over traditional injectable forms. Clinical testing will evaluate its pharmacokinetics, safety, and efficacy, ultimately advancing it toward real-world use as a viable, patient-friendly alternative for the timely treatment of anaphylaxis.

This project is co-financed by the Technology Agency of the Czech Republic under the relevant programme and is also supported by European Union funds under the National Recovery Plan.