FDA approves first nasal spray for severe allergic reactions

The Food and Drug Administration has approved the first nasal spray to stave off life-threatening allergic reactions.

Regulatory approval of the drug — neffy — is significant because other epinephrine treatments for such reactions, or anaphylaxis, require a shot.

“Anaphylaxis is life-threatening, and some people, particularly children, may delay or avoid treatment due to fear of injections,” said Kelly Stone, associate director of the Division of Pulmonology, Allergy and Critical Care at the FDA’s Center for Drug Evaluation and Research. “As a result, neffy provides an important treatment option and addresses an unmet need.”

Certain food, medication and insect stings can produce anaphylaxis in allergy sufferers. 

Persons prone to harsh reactions often carry around an injection pen just in case.

The nasal spray is manufactured by San Diego-based ARS Pharmaceuticals and is given in a single dose in one nostril.

Common side effects include throat irritation, a tingling nose, headache and feeling jittery, the FDA said.

The approval, announced Friday, was based on four studies in 175 adults showing comparable epinephrine concentrations between neffy and epinephrine injection products.