Pharmacokinetics and Safety of a Single Dose of Epinephrine Nasal Spray in Paediatric Allergy Patients

This Phase 2, open-label, single-arm study will evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of a single dose of epinephrine nasal spray (ENS) in children and adolescents 2 to 17 years of age with a diagnosed Type I allergy. Approximately 44 participants will be enrolled in two body-weight cohorts. * Participants weighing \>30 kg will receive a single 5.25 mg dose of ENS, and * Participants weighing ≥15 kg to ≤30 kg will receive a single 2.5 mg dose of ENS. The study will assess plasma epinephrine concentrations, changes in blood pressure and pulse rate, and safety and tolerability following administration of ENS. Participants will be monitored for 4 hours after dosing and will complete safety follow-up through approximately Day 15.