FDA Approves First Nasal Spray for Anaphylaxis

On Friday, August 9, 2024, the U.S. Food and Drug Administration (FDA) announced the approval of neffy, the first non-injected treatment for severe allergic reactions, providing a new option for those who fear needles. Neffy is an epinephrine nasal spray designed for adults and children over 66 pounds, offering an alternative to traditional epinephrine injections.

Dr. Kelly Stone, associate director of the Division of Pulmonology, Allergy, and Critical Care at the FDA’s Center for Drug Evaluation and Research, emphasized the significance of this approval. She noted that the fear of injections often leads to delays or avoidance in treating anaphylaxis, especially in children. The introduction of an epinephrine nasal spray is expected to reduce these barriers, enabling quicker responses to life-threatening allergic reactions.

Anaphylaxis is a severe allergic response that can be triggered by certain foods, medications, or insect stings, causing symptoms that require immediate treatment. Until now, the standard treatment has been injectable epinephrine. However, neffy, developed by ARS Pharmaceuticals, offers a needle-free alternative. This nasal spray is administered by spraying into one nostril. If symptoms persist, a second dose from a new dispenser can be given into the same nostril. Close monitoring is essential after administration to determine if further medical intervention is needed.

The FDA’s approval of neffy is based on data from four studies involving 175 healthy adults. These studies compared the blood concentrations of epinephrine following the administration of neffy to those from approved epinephrine injection products. Results indicated that neffy produced comparable blood levels of epinephrine, as well as similar increases in blood pressure and heart rate, which are critical in treating anaphylaxis.

Despite its benefits, neffy may cause side effects, including throat irritation, nasal discomfort, headache, jitteriness, fatigue, tremor, runny nose, nasal itchiness, sneezing, abdominal pain, gum pain, mouth numbness, nasal congestion, dizziness, nausea, and vomiting. The FDA also warns that certain nasal conditions, such as nasal polyps or a history of nasal surgery, might affect the absorption of neffy. Patients with these conditions should consult healthcare professionals to determine if injectable epinephrine might be a better option. There are additional precautions for people with certain coexisting conditions or sulfite allergies.

The approval of neffy comes after a series of evaluations and recommendations. An expert advisory panel supported its use in May 2023. However, the FDA initially delayed approval in September, requesting further studies. Following these additional studies, neffy has now been approved, marking a significant advancement in the treatment options available for anaphylaxis.

In summary, the FDA’s approval of neffy offers a groundbreaking needle-free alternative for treating life-threatening allergic reactions. This new option addresses the fear of injections that many people, especially children, face, potentially leading to quicker and more effective responses during allergic emergencies. As with any medication, patients should be aware of potential side effects and consult healthcare professionals to ensure neffy is the appropriate choice for their specific conditions.