The U.S. Food and Drug Administration (FDA) has approved a new nasal spray, neffy, as the first non-injected treatment for anaphylaxis, offering an alternative to the traditional epinephrine injection.
This development is particularly significant for individuals, especially children, who may hesitate or delay treatment due to a fear of needles. The availability of this nasal spray could help reduce barriers to timely treatment of life-threatening allergic reactions.
Anaphylaxis is a severe and potentially fatal allergic reaction triggered by certain allergens such as specific foods, medications, or insect stings. Until now, the only immediate treatment available was epinephrine, typically administered through an injection.
Neffy, developed by ARS Pharmaceuticals, provides a needle-free option by delivering epinephrine through a nasal spray, which is expected to be easier and more acceptable for many patients. The FDA advises that if symptoms persist after the initial dose, a second dose should be administered using a new dispenser, and medical help should be sought immediately.
The FDA’s approval of neffy is grounded in the results of four studies involving 175 healthy adults. These studies compared the epinephrine levels in the blood after administering neffy versus traditional epinephrine injections and found them to be comparable.
Furthermore, neffy was shown to effectively raise blood pressure and heart rate, key responses needed to counteract anaphylaxis, similar to the effects of injectable epinephrine.
Neffy, like all medications, may cause side effects, including throat irritation, nasal discomfort, headache, and feelings of jitteriness, among others.
Patients with specific nasal conditions, such as polyps or a history of nasal surgery, are advised to consult healthcare professionals before using neffy, as these conditions could impact the absorption of the medication.
Additionally, individuals with certain coexisting conditions or sulfite allergies should be cautious and may need to consider injectable epinephrine as an alternative.
The approval of neffy follows support from an expert advisory panel in May 2023, although the FDA had initially delayed its decision in September to request additional studies.
The introduction of this nasal spray marks a significant advancement in the treatment options available for managing severe allergic reactions, providing a less invasive and more accessible option for those at risk of anaphylaxis.
