On August 9 the U.S. Food and Drug Administration (FDA) announced it had approved an epinephrine spray for emergency treatment of severe allergic reactions and anaphylaxis for adults and children over 66 pounds.
Neffy is the first needle-free method for delivering epinephrine to treat Type I allergic reactions, including food, medications and insect bites, providing a quick response option to emergencies.
“Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” said 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. “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.”
The FDA granted the approval of Neffy to ARS Pharmaceuticals.
“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,” said Richard Lowenthal, Co-Founder, President and Chief Executive Officer, ARS Pharmaceuticals. “Epinephrine treatment is only effective if available, readily usable, and administered appropriately.
The approval was granted after four studies closely examined 175 healthy adults without anaphylaxis. These studies compared the blood concentrations resulting from the spray and the injections and also observed how they affected blood pressure and heart rate. These effects are specifically treated by epinephrine.
Neffy was fast-tracked by the FDA to fill an unmet medical need and will be available within eight weeks of approval.
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