First Nasal Spray for Treatment of Anaphylaxis is FDA-Approved The U.S. Food and Drug Administration (FDA) has approved neffy (epinephrine nasal spray) for the emergency treatment of Type I allergic reactions, including anaphylaxis, in adults and children over 30 kg (66 pounds). The approval was based on clinical studies showing that neffy provides blood concentrations of epinephrine and physiological effects, such as increased blood pressure and heart rate, similar to traditional epinephrine injection products. Following this approval, EURneffy adrenaline nasal spray was authorised for use in the EU. About Type I Allergic Reactions (Including Anaphylaxis) Type I allergic reactions, including anaphylaxis, are potentially life-threatening and require immediate treatment with epinephrine, the only FDA-approved option. Despite the effectiveness of epinephrine autoinjectors, many patients delay or avoid using them due to needle phobia, poor portability, safety concerns, and device complexity. In 2023, of the 40 million Americans at risk, only 3.2 million had an active epinephrine prescription, and among those, less than half consistently carried their autoinjector, often delaying use during emergencies. What is neffy neffy is a single-dose nasal spray that delivers epinephrine into one nostril. Similar to epinephrine injection products, if symptoms do not improve or worsen after the first dose, a second dose can be administered into the same nostril. Patients with certain nasal conditions, such as nasal polyps or a history of nasal surgery, should consult a healthcare professional as these conditions may affect drug absorption. Additionally, neffy includes warnings for individuals with coexisting conditions or allergies related to sulfites. Common side effects of neffy include throat irritation, 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. Study Design and Results The pivotal study for neffy was a randomised, crossover pharmacokinetic (PK) and pharmacodynamic (PD) trial involving 43 patients with seasonal allergic rhinitis. All participants underwent a Nasal Allergen Challenge (NAC) and were dosed with neffy. Key PD markers such as systolic blood pressure and heart rate were measured alongside PK data to assess how well the drug was absorbed and its overall effectiveness. The study found that neffy, whether administered in the same nostril or alternating nostrils, produced higher or comparable PK and PD responses compared to repeat doses of intramuscular (IM) epinephrine. This suggests that neffy may be more effective or faster-acting in treating anaphylaxis than traditional injections. Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma, ir.ars-pharma.com We are very pleased with the topline results from our repeat dose study of neffy under nasal allergen challenge conditions...The study objective was to compare twice dosing with epinephrine injection and twice dosing with neffy under normal conditions and after nasal allergen challenge. The results show that the neffy pharmacokinetic and pharmacodynamic profile is greater than or similar to intramuscular injection, the comparator FDA requested for this study. In particular, repeat dosing in the same nostril was greater in exposure than dosing once in each nostril and greater than injection on both PK exposures and PD response at all time points, which may help inform labeling and instructions for use. With these results, we are completing the necessary work to submit our response to FDA in the next couple of months. We look forward to working with the Agency in our efforts to make neffy available to patients as soon as possible. Benefits of Nasal Epinephrine Spray Nasal epinephrine sprays like neffy offer significant advantages over traditional autoinjectors, including: Ease of Use: Nasal sprays are simpler to administer, especially in emergencies, as they avoid the need for needle insertion. Reduced Anxiety: Many individuals hesitate to use autoinjectors due to fear of needles; neffy eliminates this concern. Improved Portability: neffy is compact and easier to carry, increasing the likelihood that patients will have it on hand during an emergency. These benefits address the limitations of epinephrine autoinjectors, such as needle phobia, safety concerns, and delayed administration, which can result in worse outcomes during anaphylaxis. In 2018, Allergy & Asthma Network surveyed patients and caregivers, learning their preferences for epinephrine delivery. The results showed a strong preference for needle-free options. Thomas B. Casale, M.D., Professor of Medicine and Pediatrics and Chief of Translational Research in Allergy/Immunology at the University of South Florida in Tampa, ir.ars-pharma.com When a severe, life-threatening allergic reaction occurs, it is necessary to administer epinephrine as soon as possible. Based on the single dose NAC data, my allergy colleagues and myself already believed that neffy would be effective under NAC conditions. FDA asked what would happen if NAC conditions occurred during the 10% of anaphylaxis events that require a repeat dose of epinephrine. Conclusion neffy’s approval offers a needle-free, easy-to-use option for individuals at risk of life-threatening allergic reactions. With comparable effectiveness to epinephrine injections and a more user-friendly design, neffy may improve timely treatment of anaphylaxis. Allergy & Asthma Network CEO Lynda Mitchell, allergyasthmanetwork.org We are very pleased the FDA approved neffy as a safe, efficient and effective treatment option for people at risk for severe allergic reactions. As a needle-free treatment option, we expect that neffy will reduce delays in treating anaphylaxis due to fear of needles. The epinephrine nasal spray gives people more choice to use the epinephrine treatment they want, when they need it. About ARS Pharmaceuticals, Inc. ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis. The Company is developing neffy® (previously referred to as ARS-1), an intranasal epinephrine product in clinical development for patients and their caregivers with Type I allergic reactions including food, medications and insect bites that could lead to life-threatening anaphylaxis. Read the full press release www.fda.gov ir.ars-pharma.com Manage Cookie Preferences