The U.S. Food and Drug Administration has approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (type I), including anaphylaxis, in adult and pediatric patients weighing at least 30 kgs (about 66 lbs). The approval marks the first epinephrine product for treating anaphylaxis not administered by injection.
Significance of the Approval
According to Kelly Stone, MD, PhD, 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 the rapid treatment of anaphylaxis, particularly among pediatric patients who may delay or avoid treatment because they fear injections. This approval addresses an unmet need and provides an important treatment option.
Anaphylaxis and Epinephrine
Anaphylaxis is a severe, life-threatening allergic reaction that typically involves multiple parts of the body and is considered a medical emergency. Common allergens that can induce anaphylaxis include certain foods, medications, and insect stings. Epinephrine is the only life-saving treatment option for anaphylaxis and has previously only been available as an injection.
Studies Supporting Neffy's Approval
Approval of the novel epinephrine nasal spray is based on 4 studies in 175 healthy adults without anaphylaxis that measured the epinephrine concentrations in the blood following administration of the spray or approved epinephrine injection products. The results showed comparable epinephrine blood concentrations between the novel epinephrine nasal spray and approved epinephrine injection products, as well as similar increases in blood pressure and heart rate. A study of the spray in children weighing more than 66 lbs demonstrated that epinephrine concentrations in these patients were similar to adults who received the epinephrine nasal spray.
Administration and Dosage
Epinephrine nasal spray is a single-dose nasal spray administered into one nostril. A second dose (using a new nasal spray to administer the novel spray in the same nostril) may be given if there is no improvement in symptoms or symptoms worsen. Patients may need to seek emergency medical assistance for close monitoring of the anaphylactic episode and if further treatment is required.
Warnings and Precautions
The novel spray comes with a warning that certain nasal conditions, such as nasal polyps or a history of nasal surgery, may affect the absorption of the drug, and patients with these conditions should consult with a health care professional to consider the use of an injectable epinephrine product. The novel epinephrine nasal spray also comes with warnings and precautions about the use of epinephrine by patients with certain coexisting conditions and allergic reactions associated with sulfite.
Side Effects
The most common side effects of the epinephrine nasal spray include throat irritation, intranasal paresthesia, headache, nasal discomfort, feeling jittery, paresthesia, fatigue, tremor, rhinorrhea, nasal pruritus, sneezing, abdominal pain, gingival pain, hypoesthesia oral, nasal congestion, dizziness, nausea, and vomiting.
Source: U.S. Food and Drug Administration. FDA approves first nasal spray for treatment of anaphylaxis. Published August 9, 2024.
