FDA Approves Neffy as First Needle-Free Nasal Spray for Anaphylaxis

The US Food and Drug Administration (FDA) has approved ARS Pharmaceuticals’ neffy (epinephrine nasal spray) as the first non-needle emergency treatment of allergic reactions (Type I), including life-threatening ones like anaphylaxis, in adult and pediatric patients who weigh at least 66 pounds.

Neffy is the first nasal spray formulation of epinephrine and is administrated as a single dose into one nostril. If there are no improvements in symptoms or if symptoms worsen, a second dose may be given in the same nostril. The FDA advised that individuals may need to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required.

The new treatment option offers a more accessible and user-friendly alternative to traditional injectable treatments like the EpiPen and other autoinjectors like Kaleo’s Auvi-Q that are filled with epinephrine, which is used to treat anaphylaxis and other allergic reactions.

Anaphylaxis is a rapid-onset allergic reaction that can occur within minutes of exposure to an allergen, such as food, insect stings, medications or latex. The condition can cause symptoms ranging from hives and swelling to difficulty breathing, a drop in blood pressure and even loss of consciousness. Immediate treatment is critical, as anaphylaxis can be fatal if not promptly addressed.

For decades, the standard treatment for anaphylaxis has been the use of epinephrine administered via injection, typically through an auto-injector device like the EpiPen. While effective, the injectable route can pose challenges, especially for individuals who may be reluctant or unable to self-administer an injection during an emergency.

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“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 (CDER) in a press release. “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.”

Neffy’s approval was supported by four studies involving 175 healthy adults who did not have anaphylaxis. The studies evaluated epinephrine levels in the blood after administration of neffy compared to conventional epinephrine injection products. The results demonstrated that neffy achieved comparable blood concentrations of epinephrine to those of the injectable products.

Additionally, neffy produced similar increases in blood pressure and heart rate, which are crucial effects of epinephrine in treating anaphylaxis. Among children weighing more than 66 pounds, epinephrine levels were consistent with those observed in adults who received neffy.

The nasal spray was turned down by the FDA last year and requested additional data despite support from an an FDA advisory committee.

Neffy comes with a warning that certain nasal conditions, such as nasal polyps or a history of nasal surgery, may affect its absorption. Patients with these conditions are advised to consult with a healthcare professional when considering use of an injectable epinephrine product.

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