The FDA has approved 1 mg epinephrine nasal spray for treating anaphylaxis in children aged 4 years and older. This new dosage also specifies children must weigh between 15-30 kg.
The approval was based on data from extensive clinical trials in children and adults, which were consistent with data from epinephrine injection products. Side effects in pediatric trials were generally mild and transient. Common side effects included nasal discomfort, headache, throat irritation, chest and nasal congestion, nosebleed, sneezing, runny nose, dry nose or throat, feeling tired, dizziness, nausea, and vomiting.
Epinephrine nasal spray has a shelf-life of 24 months at room temperature. It can withstand temperatures up to 50°C for up to 3 months and can be thawed after it has frozen with no impact on quality.
Epinephrine nasal spray will be available in the United States by the end of May 2025.
