FDA approves first noninjectable emergency treatment for anaphylaxis

Today, FDA approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), in adult and pediatric patients weighing ≥30 kg (about 66 pounds). Approval was based on four studies in 175 healthy adults, without anaphylaxis, that showed comparable epinephrine blood concentrations between neffy and approved epinephrine injection products. Increases in BP and heart rate were also similar between neffy and injection products. A study of neffy in children showed similar epinephrine concentrations to adults.