FDA Approves First Epinephrine Nasal Spray for Type I Allergic Reactions Including Anaphylaxis

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The FDA has approved ARS Pharmaceuticals’ neffy (epinephrine nasal spray), a first-in-class needle-free, nasal spray treatment for type I allergic reactions, such as anaphylaxis, for adults and children weighing 66 lbs. or more. According to the company, this approval offers a less painful alternative to traditional needle injections, which are often delayed due to anxiety, potentially worsening allergic reactions.¹

“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, MD, professor of medicine, pediatrics, and chief of clinical and translational research, USF Health Morsani College of Medicine's division of allergy and immunology, University of South Florida in Tampa, Florida, in a press release. “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.”

The FDA stated that the approval was based on four studies that consisted of 175 healthy adults without anaphylaxis, measuring epinephrine concentrations in the blood following administration of neffy or approved epinephrine injection products. Results demonstrated comparable epinephrine blood concentrations between neffy and approved epinephrine injection products. Further, neffy also produced increases in blood pressure and heart rate that were similar to epinephrine injection products, with both adults and children yielding similar results.²

“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, MD, PhD, associate director, division of pulmonology, allergy, critical care, FDA’s Center for Drug Evaluation and Research, in a press release. “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.”

Adverse events (AEs) in the clinical trials for neffy were generally mild without any meaningful nasal irritation or pain, and no serious AEs were reported.1 Common AEs included throat irritation, tingling nose headache, nasal discomfort, feeling jittery, tingling sensation, tremor, fatigue, runny nose, itchiness inside the nose, sneezing, abdominal pain, gum pain, numbness in the mouth, nasal congestion, dizziness, nausea, and vomiting.²

“Anyone who has experienced or witnessed an anaphylaxis reaction knows it can be very stressful deciding when to inject epinephrine to themselves or a child and often delay,” said Jonathan Spergel, chief, Allergy Program, Children's Hospital of Philadelphia, in the press release. “We know that earlier administration is better, and for many, the needle is a barrier that causes dangerous hesitation. That is why the field has long pursued an effective treatment approach that does not require an injection.”

ARS stated that it intends to offer robust programs to support patient access, aiming to limit out-of-pocket costs to $25 per each filled prescription for most patients with commercial insurance. For eligible patients without insurance or with healthcare plans that don’t cover neffy, ARS intends to offer a cash price of $199 for two doses of neffy via BlinkRx, a digital pharmacy service that is available to patients at no added cost. Further, patients can access neffy through GoodRx and eligible US citizens will be able to access neffy through the ARS Pharma Patient Assistance Program at no cost.¹

ARS expects neffy to be available in the United States within eight weeks of FDA approval, with the company intending to file for a supplemental New Drug Application for neffy to treat children weighing under 66 lbs. by the end of the third quarter of this year.¹

References

1. ARS Pharmaceuticals Receives FDA Approval of neffy® (epinephrine nasal spray), the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis. ARS Pharma. August 9, 2024. Accessed August 9, 2024. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-receives-fda-approval-neffyr-epinephrine

2. FDA Approves First Nasal Spray for Treatment of Anaphylaxis. FDA. August 9, 2024. Accessed August 9, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis