Children and adults with life-threatening allergies will have a needle-free treatment for anaphylaxis.
The Food and Drug Administration (FDA) has approved neffy epinephrine nasal spray from ARS Pharmaceuticals for the emergency treatment of anaphylaxis in people weighing at least 66 pounds. It is the first treatment that does not require an injection.
“Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections,” Kelly Stone, M.D., Ph.D., associate director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in a press release. “The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis.”
Anaphylaxis can be caused by a variety of allergens such as certain foods, medications and insect stings. Patients may experience hives, swelling, itching, vomiting, difficulty breathing and loss of consciousness. It is considered a medical emergency.
Neffy is a single dose nasal spray. Patients can be given a second dose with a new nasal spray in the same nostril if symptoms do not improve. They may need to seek emergency medical assistance for close monitoring and further treatment, according to the FDA.
J. Andrew Bird, M.D., FAAP, chair of the AAP Section on Allergy and Immunology, called the approval “excellent news for our patients.”
“Administration of epinephrine soon after the onset of anaphylaxis is important to prevent its progression, and oftentimes patients are hesitant to give themselves an injection,” said Dr. Bird, interim chief in the Division of Allergy and Immunology at UT Southwestern Medical Center and director of the Food Allergy Center at Children’s Health in Dallas. “I am hopeful that having an alternate route of administration will decrease hesitancy and improve the likelihood that patients experiencing anaphylaxis will receive epinephrine when it’s needed.”
Neffy was shown to produce comparable blood concentrations of epinephrine as well as increases in blood pressure and heart rate in healthy adults when compared to epinephrine injections during clinical trials. A study in children receiving neffy also showed epinephrine concentrations similar to adults.
People with certain nasal conditions like polyps or a history of nasal surgery should consult with a health care professional and consider using an injectable epinephrine product, according to the FDA. Neffy also contains warnings and precautions about using epinephrine with certain coexisting conditions and allergic reactions associated with sulfite.
The most common side effects after using neffy are throat irritation, tingling nose, headache, nasal discomfort, feeling jittery, tingling sensation, fatigue, tremor, runny nose, itchiness inside the nose, sneezing, abdominal pain, gum pain, numbness in the mouth, nasal congestion, dizziness, nausea and vomiting.
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