P4.A010: Pediatric doses of neffy (intranasal nasal spray) demonstrate pharmacokinetic profiles that are equivalent to epinephrine injections products

Background: Epinephrine is the first-line treatment for severe allergic reactions, including anaphylaxis. Despite epinephrine’s well documented history of safety and efficacy, patients/caregivers frequently fail to treat or delay treating severe allergic reactions, citing challenges of carrying epinephrine auto-injectors and concerns about injection. These concerns are particularly pronounced in pediatric patients, who, along with their caregivers, tend to be more anxious about injectable devices. An intranasal epinephrine spray (neffy) is being developed as a needle-free option for the treatment of severe allergic reactions.

Methods: A randomized, single-dose, phase 1 pharmacokinetic study was conducted in 42 pediatric allergy patients. Patients weighing 15-30 kg (N=21) received neffy 1 mg and patients weighing ≥30 kg (N=21) received neffy 2 mg.

Results: neffy 1 mg resulted in a mean peak plasma concentration (Cmax) of 651 pg/mL and a median time to reach Cmax (tmax) of 20.0 minutes. neffy 2 mg resulted in a mean Cmax of 690 pg/mL and a median tmax of 29.5 minutes. The pharmacokinetic profiles were well correlated with pharmacodynamic responses (blood pressure and heart rate). Similar to what has been observed in adults, pediatric pharmacokinetic and pharmacodynamic findings were within range of approved injection products. Most adverse events were mild, and none were serious or resulted in withdrawal.

Conclusion: Pediatric doses of neffy have a favorable safety profile with pharmacokinetic and pharmacodynamic profiles within range of approved injection products. neffy is expected to be a safe and effective option for the treatment of severe allergic reactions and anaphylaxis in pediatric patients.