Development of the Epinephrine Cyclops® inhaler for treatment of anaphylaxis
This project involves the development of Epinephrine Cyclops® for treatment of severe allergic reactions and anaphylaxis. The collaboration includes two pharmaceutical SMEs (PureIMS and PIMS Epinephrine), the UMCG department of Internal Medicine-Allergology and the UG department of Pharmaceutical Technology and Biopharmacy.
Allergies and anaphylaxis are on the rise in our society. Epinephrine is the drug of choice for treatment of severe allergic reactions and anaphylaxis as it directly and effectively counteracts potentially life-threatening anaphylactic symptoms. The current first-line emergency treatment consists of self-administration in the thigh using an epinephrine auto-injector (EAI), but various issues and barriers exist that withhold them from correctly using their EAI or even using them at all. There is thus a distinct need for an improved administration method of epinephrine.
Inhalation of epinephrine, especially by means of a conveniently sized and easy-to-use inhaler can offer great improvements in terms of speed of administration, fast clinical onset of action, user-friendliness, usability, and prolonged shelf-life, for which we develop Epinephrine Cyclops® inhaler.
During the project efforts were first focused on developing a suitable pharmaceutical formulation. A major challenge was stabilising the formulation. Due to this stability issue, the project experienced delays and formulation work continued for the remainder of the project. Ultimately, a First in Man dose-finding study with Epinephrine Cyclops® was performed and several formulations with sufficient stability were developed.
Second, a clinical development program was devised that outlines the various clinical studies required to demonstrate the safety and efficacy of Epinephrine Cyclops®. The development program was submitted to the Swedish Medical Products Agency (MPA) for scientific advice and they raised regulatory objections that posed a barrier to the registration of inhalable adrenaline. Based on these objections, the development strategy and planned clinical studies were reconsidered and adjusted.
The positive stability indicating results of this project, reaffirm our strong believe that Epinephrine Cyclops® is a promising drug candidate.
