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FDA approves first nasal spray epinephrine for treating severe allergic reactions

The U.S. Food and Drug Administration (FDA) has approved neffy, the first epinephrine nasal spray for the emergency treatment of life-threatening allergic reactions, including anaphylaxis. This new option is available for adults and children who weigh at least 30 kilograms (about 66 pounds).

Previously, epinephrine was only available as an injection, which some patients, particularly children, might avoid due to a fear of needles. The nasal spray offers a needle-free alternative, potentially increasing the likelihood of timely treatment during anaphylactic emergencies.

The approval was based on studies showing that neffy provides similar levels of epinephrine in the blood and similar physiological effects as traditional epinephrine injections. The product was granted Fast Track designation by the FDA, highlighting its importance in addressing an unmet medical need.

Neffy is administered as a single dose in one nostril, with a second dose allowed if symptoms persist. However, individuals with certain nasal conditions should consult a healthcare provider before using the spray. The most common side effects include throat irritation, nasal discomfort, and dizziness.

The approval of neffy marks a significant advancement in the treatment options available for those at risk of severe allergic reactions.