The U.S. Food and Drug Administration (FDA) has approved Neffy, the first needle-free treatment for anaphylaxis, a severe allergic reaction often triggered by foods, medicines, and insect stings. This new epinephrine nasal spray offers an alternative to the traditional EpiPen injections and is approved for use in adults and children weighing at least 30 kilograms (66 pounds).
Neffy can be administered by spraying a single dose into one nostril. If symptoms do not improve or worsen, a second dose can be administered in the same nostril, according to the FDA.
“Anaphylaxis is life-threatening, and some people, particularly children, may delay or avoid treatment due to fear of injections,” said Dr. Kelly Stone, associate director of the division of pulmonology, allergy, and critical care in the FDA’s Center for Drug Evaluation and Research. “The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis and provides an important treatment option to address an unmet need.”
Understanding Anaphylaxis
Anaphylaxis is a severe allergic reaction that affects multiple parts of the body and requires immediate medical attention. It is often triggered by certain foods, medications, insect stings, or latex. Symptoms of anaphylaxis include hives, swelling, itching, vomiting, difficulty breathing, and loss of consciousness. Epinephrine is the only lifesaving emergency treatment for anaphylaxis and has been traditionally administered via injection to manage symptoms until medical care is available.
Effectiveness and Safety of Neffy
Neffy has been shown to be as effective as injected epinephrine. In studies involving 175 healthy adults, researchers found that the nasal spray delivered similar levels of epinephrine in the blood and achieved comparable improvements in heart rate and blood pressure as the injected version. Studies also indicated that blood concentrations of epinephrine in children over 66 pounds were similar to those in adults who used Neffy.
Side Effects and Considerations
Common side effects of Neffy include throat irritation, nasal discomfort, headache, tingling sensation, fatigue, tremor, runny nose, itchiness inside the nose, sneezing, abdominal pain, gum pain, mouth numbness, nasal congestion, dizziness, nausea, and vomiting.
Neffy is not suitable for everyone, particularly individuals with certain nasal conditions such as nasal polyps or a history of nasal surgery, as these can reduce the effectiveness of the nasal spray.
Despite these considerations, Neffy represents a significant advancement in the treatment of anaphylaxis. Kathy Przywara, vice president of community at the Asthma and Allergy Foundation of America, highlighted the potential benefits: “Nasal epinephrine spray may remove some of the barriers that prevent people from using epinephrine. The needle-free device removes the fear of needle-based injections and may be easier to use, increasing confidence among people managing life-threatening allergies.”
