FDA has 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 who weigh at least 30 kilograms (about 66 pounds).”
Kelly Stone, MD, PhD, Associate Director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research, says that this approval “provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection.”
Epinephrine is the “only life-saving treatment for anaphylaxis and has previously only been available for patients as an injection.” Neffy’s approval is based on four studies conducted across 175 healthy adults “that measured the epinephrine concentrations in the blood following administration of neffy or approved epinephrine injection products. Results from these studies showed comparable epinephrine blood concentrations between neffy and approved epinephrine injection products.”
Neffy is “a single dose nasal spray administered into one nostril.” A second dose can be administered “if there is no improvement in symptoms or symptoms worsen.”
