“Neffy” offers a needle-free option for rapid emergency treatment of severe allergic reactions.
The U.S. Food and Drug Administration (FDA) has approved Neffy, the first epinephrine nasal spray for emergency treatment of severe allergic reactions, including life-threatening anaphylaxis, in adults and children. It is administered as a single dose in one nostril, although a second dose may be needed if symptoms persist or worsen.
“Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” said Associate Director Kelly Stone 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.”
Anaphylaxis is a critical condition triggered by allergens such as certain foods, medications, and insect stings, and epinephrine is the sole life-saving treatment available, typically administered via injection. Neffy was granted Fast Track designation and approved by the FDA for ARS Pharmaceuticals.
As the Lord Leads, Pray with Us…
- For Associate Director Stone as she facilitates the testing of therapies and medications in the FDA’s Pulmonology, Allergy, and Critical Care Division.
- For Commissioner Robert Califf and FDA officials as they review treatments and evaluate recommendations and studies for drug approval.
- That those who are at risk of anaphylactic shock will benefit from the release of the nasal treatment.
Sources: Food and Drug Administration
