Neffy Nasal Spray Approved for Anaphylaxis

On August 9, 2024, the U.S. Food and Drug Administration (FDA) approved ARS Pharmaceuticals’ neffy^® (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I) including anaphylaxis. It is a single-use, prefilled nasal spray that delivers 2mg/0.1mL of epinephrine per administration. The recommended dose for patients who weigh at least 30kg (66 pounds) is one spray into one nostril. Patients are then advised to seek medical assistance for further monitoring. A new device can administer a second dose into the same nostril five minutes after the first dose if symptoms do not improve or worsen. Neffy will be supplied in a carton containing two single-dose nasal sprays. ARS Pharmaceutics plans on launching Neffy within the next two months. While wholesale pricing has not been disclosed, ARS Pharmaceuticals also plans on making it available for $199 for the two doses through an online service, BlinkRx. The complete prescribing information can be found here.

At a Glance

• Brand Drug: neffy (epinephrine nasal spray)
• Manufacturer: ARS Pharmaceuticals
• Date Approved: August 9, 2024
• Indication: for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater
• Dosage Forms Available: Single-use nasal spray devices containing 2mg/0.1mL of epinephrine
• Launch Date: Within the next two months
• Estimated Annual Cost: Wholesale pricing has not been released. However, the company has indicated that Neffy will also be available through BlinkRx at a cash price of $199 for two doses.
• Anaphylaxis is a critical medical emergency triggered by allergens such as foods, medications, or insect stings. Symptoms include hives, swelling, difficulty breathing, and loss of consciousness.
• According to the manufacturer, about 40 million people in the U.S. have experienced severe allergic reactions following exposure to food, insect stings or venom. About three million Americans have a prescription for an injectable epinephrine product, such as EpiPen^® (epinephrine auto-injector – Mylan, generic).
• Epinephrine acts on alpha and beta-adrenergic receptors in the body to counteract many of the effects of anaphylaxis by reducing the widening of the blood vessels (vasodilation), narrowing of the airways (bronchospasm), and other related symptoms.
• Approval was based on studies showing comparable epinephrine blood concentrations and similar physiological effects between neffy and injectable epinephrine products.
• While neffy was studied in patients with allergic rhinitis, absorption may be altered in patients with other structural or nasal conditions, such as polyps, or who have a history of nasal injuries, fractures, or nasal surgery. Patients should consult with a healthcare professional before using neffy.
• As with all of the epinephrine products, it should be used with caution in patients with heart disease.
• Neffy offers an alternative delivery route to epinephrine injections, including EpiPen, Symjepi^® (epinephrine prefilled syringe – Adamis Pharmaceuticals), and Auvi-Q^® (epinephrine auto-injector – Kaleo).
• ARS Pharmaceuticals plans to file for a lower strength of neffy for use in children weighing 15kg (33 pounds) to <30kg during the third quarter of 2024. Once submitted, the FDA generally requires at least six months to review the application.