The FDA has approved a new nasal spray, Neffy, for the treatment of severe allergic reactions in children ages 4 and older. This groundbreaking treatment is the first to offer a needle-free option for emergency use, making it an important alternative for those who struggle with traditional epinephrine injections.
Allergic reactions are caused when the immune system reacts abnormally to common triggers, such as certain foods, medications, or insect stings. Symptoms can include hives, swelling, itching, nausea, or difficulty breathing. In extreme cases, anaphylaxis can occur, which is a life-threatening condition that demands immediate intervention with epinephrine. Epinephrine works by raising blood pressure, opening airways, and reducing swelling to help restore normal breathing and prevent the worst effects of the reaction.
Neffy, a nasal epinephrine spray, was first approved by the FDA in 2024 for use in older children and adults. At that time, it provided a needle-free option for those who needed emergency treatment. However, younger children, especially those weighing under 33 pounds, still had to rely on injection pens, which can be intimidating and difficult to use for both parents and kids. With the new approval of Neffy 1 milligram, the product is now available in a dosage suitable for younger children, making it a safer, easier-to-use option in emergencies. This new version of Neffy helps eliminate the delays or accidental injuries associated with traditional epinephrine injections, offering a more practical solution for caregivers in a time of crisis.
Clinical trials have shown that Neffy 1 milligram is as effective as injectable epinephrine in treating severe allergic reactions in both children and adults. The studies also revealed that it is generally well-tolerated, with only mild and temporary side effects reported. Common side effects include nasal discomfort, tingling, nosebleeds, sneezing, runny nose or throat, congestion, nausea, vomiting, headache, anxiety, dizziness, and feelings of fatigue or overstimulation. These side effects are typically short-lived and not serious.
One of the key advantages of Neffy is that it is simple to use, even for those with no medical training. Studies indicate that children as young as 10 have been able to use it correctly, and the spray can be administered by anyone teachers, babysitters, or other caregivers without requiring special skills or knowledge. This ease of use makes it an ideal solution for families and communities where allergic reactions could potentially occur without warning.
Neffy’s manufacturer, ARS Pharma, advises parents and caregivers to carry two Neffy sprays, as allergic reactions can be unpredictable, and a second dose may be necessary if symptoms continue or return. If a second dose is required, it should be administered into the same nostril as the first. Families should also inform their child’s healthcare provider about any existing nasal problems, or heart, kidney, or thyroid conditions, as well as any other medications the child is taking, as these may influence how well Neffy works.
The approval of Neffy represents an important step forward in the management of allergic reactions, particularly for younger children. By offering a safe, effective, and easy-to-use alternative to injections, this new treatment gives families more control over emergencies and improves their peace of mind when dealing with potentially life-threatening allergic reactions.
Neffy is expected to be available by May, and it is hoped that its release will help many families manage severe allergic reactions more effectively. With its needle-free design and ease of use, Neffy is poised to become an essential tool in the fight against anaphylaxis.
