FDA Approves Neffy Epinephrine Nasal Spray for Severe Allergic Reactions
First Needle-Free Emergency Treatment for Anaphylaxis
August 9, 2024
The Food and Drug Administration (FDA) has approved the first nasal spray epinephrine drug for severe allergic reactions known as anaphylaxis. Neffy, a single-dose nasal spray used in one nostril, was approved for use in adults and children who weigh at least 66 pounds.
Anaphylaxis is a potentially life-threatening allergic reaction that can occur within seconds or minutes of exposure to an allergen. Symptoms of anaphylaxis include difficulty breathing, wheezing, hives, swelling of the face, lips, tongue, or throat, and dizziness.
Neffy is the first nasal spray epinephrine product approved by the FDA for the emergency treatment of anaphylaxis. It is intended for use in adults and children who have been prescribed epinephrine for the treatment of anaphylaxis and who are at risk for allergic reactions.
The FDA's approval of Neffy is based on a clinical trial that included over 500 adults and children with a history of anaphylaxis. The study found that Neffy was effective in treating anaphylaxis symptoms, including difficulty breathing and wheezing.
Neffy is available by prescription only. It is important to note that Neffy is not a substitute for epinephrine auto-injectors. Patients who have been prescribed epinephrine auto-injectors should continue to carry and use them as directed by their doctor.
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