Intranasal adrenaline: A new treatment for anaphylaxis.

Pediatric anaphylaxis management faces significant barriers due to needle phobia and technical challenges associated with intramuscular adrenaline auto-injectors, resulting in suboptimal usage in children. Intranasal adrenaline formulations represent a paradigm shift addressing these longstanding clinical challenges. This review synthesizes the current evidence on intranasal adrenaline formulations, focusing on clinical efficacy, drug and device technology, and safety profiles. Three leading intranasal adrenaline products are examined: neffy® (ARS Pharmaceuticals), which utilizes Intravail® technology and is the first FDA-approved commercially available intranasal adrenaline product; UTULY™ (Bryn Pharma), which employs a high-dose strategy (13.2 mg) to overcome absorption barriers; and FMXIN002 (Nasus Pharma), which features microsphere powder technology with a 5-year room-temperature stability. Pharmacokinetic studies of intranasal products consistently demonstrate plasma concentrations that are comparable to or exceed intramuscular manual injections, with faster absorption kinetics. A Phase 3 clinical study in 15 pediatric patients experiencing anaphylaxis during oral food challenges demonstrated effective symptom resolution with a median time of 16 min and no serious adverse events. Counterintuitively, nasal congestion and upper respiratory tract infections appear to enhance rather than impair adrenaline absorption-a counterintuitive finding that mitigates concerns about delivery reliability. These needle-free formulations offer significant advantages including the elimination of injection-related barriers, simplified administration techniques, enhanced thermal stability, and preserved therapeutic efficacy. Intranasal adrenaline represents a transformative advancement in anaphylaxis management, particularly benefiting pediatric populations where injection anxiety is prevalent.