FDA Approves Epinephrine Nasal Spray

The U.S. Food and Drug Administration (FDA) has approved the first needle-free alternative to the EpiPen. ARS Pharmaceuticals’ Neffy is a single-use epinephrine nasal spray for the emergency treatment of allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds).

Approval comes after FDA declined to approve Neffy in 2023, asking the manufacturer to complete a study comparing repeat doses of Neffy to repeat doses of epinephrine injection. Neffy is a single-dose nasal spray administered into one nostril. A second dose (using a new nasal spray in the same nostril) may be given if there is no improvement in symptoms or if symptoms worsen.

The approval represents the first significant change in epinephrine delivery in more than 35 years. “This approval marks a watershed moment in addressing an unmet medical need for people with type 1 allergies — a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many,” said Richard Lowenthal, MS, MSEL, ARS co-founder, president and CEO.    ❖