On Friday, the U.S. Food and Drug Administration (FDA) approved neffy, a nasal spray for the emergency treatment of allergic reactions, including life-threatening anaphylactic shock.
The spray is approved for use in adults and children who weigh at least 66 pounds (30 kilograms). It was greenlighted through one of the FDA’s drug expedition processes. Anaphylaxis occurs when the body goes into shock from a massive allergic reaction.
Blood pressure rapidly drops, heart rate increases, airways constrict, and swelling can occur in the upper airways—all of which can potentially lead to death. Epinephrine, which reverses most anaphylactic symptoms by increasing blood pressure, opening the airways, and reducing swelling, is the first-line treatment for this condition. However, all epinephrine products currently approved to treat anaphylaxis are administered by injection, like EpiPens, which can be painful.
“The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis. As a result, neffy provides an important treatment option and addresses an unmet need.” Neffy is a single-dose nasal spray administered into one nostril.
If symptoms worsen or do not improve, a second dose through the same nostril may be given. Patients may need to seek emergency medical assistance for close monitoring if further treatment is required. Nasal polyps or a history of nasal surgery may slow the absorption of neffy.
The studies showed that, following neffy admini.