Hikma Pharmaceuticals USA Inc.
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.
Inclusion Criteria: * Male and female children and adolescents aged between 2 and 17 years (inclusive) at the time of Screening. * Diagnosed with type I allergy with food or venom allergy, which is prone to anaphylactic reactions and requires the prescription of epinephrine products. * Body weight ≥15 kg (33 lbs) measured in light clothing and without shoes. * Have a BMI within the 5-95% percentile, considering the regional, sex and age-specific growth charts. * Signed informed consent form (ICF) by the parent/legally authorised representative (LAR). * Signed assent form by the child/adolesce…
A single dose of epinephrine nasal spray (ENS) will be administered intranasally based on body weight: 2.5 mg for participants weighing ≥15 to ≤30 kg.
A single dose of epinephrine nasal spray (ENS) will be administered intranasally based on body weight: 5.25 mg for participants weighing \>30 kg.
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