First Nasal Spray for Anaphylaxis Approved by FDA

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The first nasal spray for emergency treatment of type 1 allergic reactions, including anaphylaxis, in adults and in children who weigh at least 30 kilograms was approved by FDA on Aug. 9, 2024 (1,2). Neffy is a single-dose epinephrine nasal spray used to treat allergic reactions and was approved through FDA’s Fast Track designation. Epinephrine has only been previously delivered by injection.

According to FDA, the approval of Neffy was based on four studies that measured epinephrine concentrations in 175 adults following administration of Neffy or injected epinephrine. Results of blood concentrations between Neffy and epinephrine injection were comparable. Similar increases in blood pressure and heart rate were also seen. Epinephrine blood concentrations in children who weighed more than 66 pounds and were given Neffy were similar to adults.

“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 FDA’s Center for Drug Evaluation and Research, in an FDA press release (1). “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.”

According to ARS Pharmaceuticals, the company that applied for FDA approval of the drug, type 1 allergic reactions result in approximately 500,000 emergency room visits each year (2). Anaphylaxis, which is life-threatening, is considered a medical emergency.

“Until today, patients with severe allergic reactions, including anaphylaxis, only had one treatment option—an often painful and anxiety-inducing needle injection of epinephrine. In some cases, patients would delay or not administer the life-saving treatment at the onset of symptoms, increasing the risk for a severe reaction or negative outcomes requiring additional emergency medical treatment,” said Thomas B. Casale, professor of Medicine and Pediatrics and Chief of Clinical and Translational Research in the USF Health Morsani College of Medicine's Division of Allergy and Immunology at the University of South Florida in Tampa, Fl., in a press release (2). “FDA approval of Neffy means that patients with severe allergies finally gain a long-awaited, needle-free, easy-to-carry epinephrine delivery method that has the potential to reduce time to administration, which can lead to better clinical outcomes and improvements in quality of life for patients and their caregivers.”

“This approval marks a watershed moment in addressing an unmet medical need for people with Type I allergies—a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many,” said Richard Lowenthal, co-founder, president, and chief executive officer, ARS Pharmaceuticals, in the company press release (2). “Epinephrine treatment is only effective if available, readily usable, and administered appropriately. Our team has worked tirelessly to create an easy-to-carry, easy-to-use, needle-free device that offers peace of mind to patients and caregivers by enabling them to administer epinephrine quickly and confidently when needed. We thank the FDA staff for their partnership and support in the development of Neffy, and are deeply grateful to the severe allergy community, including advocates, patients, parents, and healthcare professionals, for their contributions to the development of Neffy as an important, life-saving treatment.”

Nasal polyps and other nasal conditions may impact the absorption of Neffy, warns FDA. Side effects of Neffy includethroat 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.

References

1. FDA. FDA Approves First Nasal Spray for Treatment of Anaphylaxis. Press Release. Aug. 9, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis
2. ARS Pharmaceuticals. ARS Pharmaceuticals Receives FDA Approval for Neffy (Epinephrine Nasal Spray), the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis. Press Release. Aug. 9, 2024. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-receives-fda-approval-neffyr-epinephrine