Abstract
Background
Anaphylaxis is a life-threatening clinical presentation of acute systemic allergic reactions. Timely administration of epinephrine, usually by intramuscular autoinjector, is a robust life-saving treatment. Despite the critical necessity, there are multiple deterrants to patients’ proper use of epinephrine autoinjectors. FMXIN002 is a novel nasal dry powder formulation of epinephrine in a single-use device, offering first-in-class alternative treatment.
Objective
To measure epinephrine pharmacokinetics, pharmacodynamics and safety following a single administration of FMXIN002 at doses of 3.6 and 4.0 mg epinephrine versus IM autoinjector 0.3 mg, in healthy adults.
Methods
An open-label, single-dose, three-treatment, crossover, randomized, comparative bioavailability study with 12 healthy adults, female and male. FMXIN002 stability was also tested.
Results











