The Food and Drug Administration approved the first needle-free alternative to the EpiPen on Friday, a single-use epinephrine nasal spray for the emergency treatment of allergic reactions, including anaphylaxis.
The agency said it approved Neffy, from ARS Pharmaceuticals, for use in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds). The approval represents the first significant change in epinephrine delivery in more than 35 years, the company said.
“This approval marks a watershed moment in addressing an unmet medical need for people with Type I allergies — a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many,” Richard Lowenthal, ARS co-founder, president and CEO said in a statement.