FDA Approves ARS Pharmaceuticals' Neffy for Emergency Treatment of Allergic Reactions
The U.S. Food and Drug Administration (FDA) has approved ARS Pharmaceuticals Inc.'s SPRY neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), for adult and pediatric patients. This approval marks a significant development in the treatment of anaphylaxis, offering patients a non-injectable alternative to epinephrine autoinjectors like EpiPen and Auvi-Q.
Neffy's approval is based on four studies in 175 healthy adults without anaphylaxis. These studies demonstrated that Neffy delivers comparable epinephrine blood concentrations to approved epinephrine injection products. Additionally, Neffy showed similar increases in blood pressure and heart rate as epinephrine injection products, both of which are crucial effects in treating anaphylaxis. A study in children weighing more than 66 pounds also showed similar epinephrine concentrations to adults who received Neffy.
Neffy is a single-dose nasal spray administered into one nostril. As with epinephrine injection products, a second dose (using a new nasal spray to administer Neffy in the same nostril) may be given if symptoms do not improve or worsen. This approval comes almost two months before the PDUFA target action date of October 2, 2024.
The approval of Neffy provides patients with a new option for the emergency treatment of anaphylaxis. This non-injectable alternative may be more appealing to some patients who are hesitant to use needles. Additionally, Neffy's nasal spray delivery may be easier to administer in certain situations, such as when a patient is experiencing severe symptoms.