FDA approves first nasal spray for anaphylaxis
The Food and Drug Administration has approved ARS Pharmaceutical’s Neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (type I), including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds).
"Today's approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections," said 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. As a result, Neffy provides an important treatment option and addresses an unmet need."
Allergic reactions happen when a person's immune system reacts abnormally to a substance that normally does not cause symptoms. 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. Symptoms usually occur within minutes of exposure and include, but are not limited to, hives, swelling, itching, vomiting, difficulty breathing and loss of consciousness. Epinephrine is the only life-saving treatment for anaphylaxis and has previously only been available for patients as an injection, the FDA said.
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Neffy is a single dose nasal spray administered into one nostril. As with epinephrine injection products, a second dose (using a new nasal spray to administer Neffy 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 in the event further treatment is required, the FDA said.