The Food Pharmacy (FDA) has approved NEFFY.® (Epinephrine nasal spray) 1 mg is 4 years old and 1 mg for emergency treatment of the first type allergic reaction, including anaphylaxis in pediatric patients with a weight of less than 15 to 30 kg. Previously, 2mg capacity was only available for adults and children with at least 30kg.
The approval of 1mg is supported by estimating the data of a single cancer study, including the clinical pharmacology study of adults and a patient (n = 42) that weighs more than 15 kg (n = 42). The pediatric study evaluated the pharmacology and biography of epinephrine after 1 mg of NEFFY (15kg to 30 kg) and 2 mg (≥30kg).
The results showed that the geometric average plasma epinephrine concentration time profile for the two weight groups was numerically higher than the adults who received 2 mg of NEFFY. Regarding the systolic blood pressure (SBP) and the pulse rate (PR), the intermediate change of SBP from the baseline after 60 minutes was numerically lower than the adult who received 2 mg of NEFFY, and the intermediate change of the PR was within the scope of an adult with a dose of 2 mg.
The most common side effects in pediatric patients with more than 15 kg were nasal inconveniences, nasal congestion, corruption, rhinitis, sneezing, upper respiratory congestion, astics, rhinalgia, nasal drying, dry throat, fatigue and jittery.
Richard Lowenthal, CEO, CEO, CEO, CEO of Richard Lowenthal, CEO, and CEO, “Nearly 4 out of 10 prescriptions for the US Epinephrine written for children under 18 years of age, we have access to options without needles for serious allergies. I think it will reduce hesitation when improving and treating these vulnerable groups. “We will also eliminate dangers such as accidental needle injuries to children and caregivers.”
Since the absorption of neffy can be affected in certain nasal cavity (e.g. nose polyps, troops of nose surgery), these patients can consider the use of injectable epinephrine products.
NEFFY is administered at a single capacity (1 mg or 2 mg epineprine) coco spray. Patients who do not experience improvement after a single dose can use a new cospray in the same nose hole to provide a secondary capacity that started 5 minutes after the first dose.
NEFFY 1mg is expected to be provided by the end of May 2025.
