FDA Alert

FDA Approves Epinephrine Nasal Spray for Allergic Reactions, Anaphylaxis

Anthony Calabro, MA

On August 9, the FDA approved an epinephrine nasal spray for treating emergency allergic reactions, particularly anaphylaxis. The approval is for adult and pediatric patients who weigh 66 pounds or more.

Anaphylaxis is a severe, life-threatening allergic reaction. Certain foods, medications, and/or insect stings can trigger anaphylaxis, with symptoms like hives, swelling, itching, vomiting, difficulty breathing, and loss of consciousness occurring within minutes. Importantly, injectable epinephrine had been the only life-saving product available for treating anaphylaxis.

“Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection,” 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, said in a press release. “Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections.”

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Dr Stone also noted that the availability of epinephrine nasal spray now fills an unmet need by potentially reducing barriers to rapid treatment of anaphylaxis.

The single-dose nasal spray should be administered into one nostril. A second dose in the same nostril may be given if the patient shows no improvement or if the symptoms worsen.

The FDA’s approval follows four studies, which showed comparable epinephrine blood concentrations between the nasal spray product and approved epinephrine injection products. The nasal spray showed similar increases in blood pressure and heart rate as epinephrine injection products. Further, for children weighing more than 66 pounds, epinephrine concentrations in children were similar to adults who received the nasal spray.

The most common side effects 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.

Reference
FDA approves first nasal spray for treatment of anaphylaxis. News release. US Food and Drug Administration; August 09, 2024. Accessed August 15, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis?utm_medium=email&utm_source=govdelivery.