Neffy (epinephrine) / ARS Pharma, Neurelis, ALK-Abello, Alfresa Pharma Corp, CSL Behring, Pediatrix Therap, Orbimed - LARVOL DELTA

Intranasal Epinephrine (Neffy) for Emergency Treatment of Type I Allergic Reactions. (PubMed, Am Fam Physician) - No abstract available

Journal • Allergy

Intranasal adrenaline: A new treatment for anaphylaxis. (PubMed, Pediatr Allergy Immunol) - "These needle-free formulations offer significant advantages including the elimination of injection-related barriers, simplified administration techniques, enhanced thermal stability, and preserved therapeutic efficacy. Intranasal adrenaline represents a transformative advancement in anaphylaxis management, particularly benefiting pediatric populations where injection anxiety is prevalent."

Journal • Review • Allergy • Immunology • Infectious Disease • Mood Disorders • Pediatrics • Psychiatry • Respiratory Diseases

Evaluating Physician Perception Of Intranasal Epinephrine (Neffy) In Anaphylaxis. (AAAAI 2026) - "Conclusions This study concludes that physician's overall perception of neffy is positive, but they would still prefer EAI backup. The study also highlights the limited awareness of indications of Neffy among physicians, emphasizing the need for active education."

Allergic Rhinitis • Immunology • Inflammation • Otorhinolaryngology

Real-world Use of Intranasal Epinephrine During IgE-mediated Reactions (AAAAI 2026) - "Adverse reactions to neffy reported were sneezing and headaches. Conclusions In routine allergy practice, neffy provides rapid, effective symptom relief comparable to IM epinephrine."

Clinical • Late-breaking abstract • Real-world • Real-world evidence • Dermatology • Hypotension • Immunology • Urticaria

Clinician Familiarity with Intranasal Epinephrine Correlates with Prescribing Confidence in Safety-Net Primary Care Settings (AAAAI 2026) - "Conclusions Familiarity is the principal determinant of confidence in prescribing intranasal epinephrine. Targeted education, hands-on exposure, and insurance advocacy are essential to integrate Neffy into primary care anaphylaxis management."

Clinical • Immunology

The Expected Value of Nasal Epinephrine Generated from Needle Aversion (AAAAI 2026) - "Including a daily needle-related QoL decrement increased the VBP by 734% to 1,288% above baseline. Conclusions Needle-free epinephrine administration is associated with value separate from its clinical efficacy and shelf life, particularly in the expected QoL gains from avoiding daily needle carry."

Treatment Adherence Related to Nasal Epinephrine versus Autoinjector in Food Allergic Adult and Adolescent Patients (AAAAI 2026) - "The finding is similar for adolescent patients (78% with IN device and 69% with EAI, p=0.002). Conclusions Both adults and adolescents reported a greater willingness to immediately administer epinephrine with a hypothetical IN device than with an autoinjector."

Adherence • Clinical • Food Hypersensitivity

Relative Importance of Characteristics of Epinephrine Treatments for Severe Food Allergic Reactions – A Discrete Choice Experiment with Patients (AAAAI 2026) - "Conclusions Adult and pediatric patients (caregiver proxies) prioritized faster symptom relief and lower device failure risk in treatment selection. Route of administration was noted to be more important for pediatric patients."

Clinical • Allergy • Food Hypersensitivity • Immunology

Treatment Preference Related to Nasal Epinephrine versus Autoinjector in Food Allergic Adult and Adolescent Patients (AAAAI 2026) - "Conclusions In a hypothetical scenario as part of an online survey, adult allergy patients, particularly if they are needle-phobic, reported that they would be significantly more likely to carry an IN device vs an EAI. This finding suggests a potential for better adherence to epinephrine carriage with the IN device."

Clinical • Food Hypersensitivity • Immunology

Pharmacokinetics and Pharmacodynamics of Epinephrine Nasal Spray and Intramuscular Epinephrine 0.5 mg Injection (AAAAI 2026) - "Median time to Cmax (tmax) was 20.5 and 45 minutes and mean AUC0-t values were 40900 and 43700 min*pg/mL for Neffy® and IM 0.5 mg, respectively. Conclusions The pharmacokinetic and pharmacodynamic profiles of Neffy® 2 mg are comparable to/greater than those of manual IM 0.5 mg."

PK/PD data • Allergy • Food Hypersensitivity • Immunology

EPI-U02: AN OUTPATIENT, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED, CROSS-OVER STUDY OF THE EFFICACY OF ARS-2 IN PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA (clinicaltrialsregister.eu) - P1/2 | N=22 | Not yet recruiting | Sponsor: Ars Pharmaceuticals IRL Limited

New P1/2 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Efficacy of epinephrine nasal spray in the treatment of urticaria. (PubMed, J Allergy Clin Immunol Pract) - "ARS-2 may offer a safe and effective treatment option for urticaria exacerbations."

Journal • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Pruritus • Urticaria

Epinephrine nasal spray for anaphylaxis: a preferred needle-free self-treatment. (PubMed, Ann Med Surg (Lond)) - "Early data indicate effective management of anaphylaxis with this device, though further studies in broader populations are warranted. Adoption of nasal epinephrine may improve timely treatment, increase accessibility, and offer a safer, patient-centered approach to emergency allergic reactions."

Journal • Allergy

Pharmacokinetics and pharmacodynamics following repeat dosing of neffy (epinephrine nasal spray) versus intramuscular injection during induced allergic rhinitis. (PubMed, J Allergy Clin Immunol Pract) - "Repeated dosing of neffy, including during NAC-induced allergic rhinitis, yields PK/PD profiles comparable or greater to IM epinephrine, supports same-nostril repeat dosing, and provides a well-tolerated, needle-free option for patients who may require a second dose."

Journal • PK/PD data • Allergic Rhinitis • Allergy • Immunology • Inflammation

ALK receives positive recommendation for EURneffy 1 mg: A needle-free anaphylaxis treatment for children (The Manila Times) - "The positive CHMP opinion supports an extension to the existing marketing authorisation for EURneffy 2 mg granted by the European Commission (‘EC’) in August 2024 for the emergency treatment of anaphylaxis in adults and children who weigh ≥30 kg....The CHMP opinion will now be reviewed by the EC. If granted, the marketing authorisation, which is expected within the coming months, will be valid in all EU member states, as well as Iceland, Liechtenstein and Norway."

CHMP • Allergy

▼ EURneffy epinephrine nasal spray. (PubMed, Drug Ther Bull) - No abstract available

Journal • Allergy • Immunology

Drugs past their expiration date. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

neffy (epinephrine nasal spray) Approved in China as the First and Only Community Use Epinephrine Product for the Treatment of Allergic Reactions (anaphylaxis) (GlobeNewswire) - "neffy is the first epinephrine product approved for use out of a hospital setting in China for adults and children (>30 kg) living with severe allergic reactions. Pediatrix Therapeutics, which has a license from ARS Pharma to market neffy in China..., expects availability in the spring of 2026....ARS Pharma and Pediatrix Therapeutics anticipate filing for approval of neffy 1 mg dose for children greater than 15 kg and less than 30 kg in the coming months."

China approval • China filing • Launch non-US • Allergy

Real-world data on the effectiveness of neffy in clinical practice. (PubMed, Ann Allergy Asthma Immunol) - No abstract available

Journal • Real-world evidence

First reported allergen immunotherapy anaphylaxis treated with neffy nasal spray: A case series. (PubMed, J Allergy Clin Immunol Glob) - "The neffy intranasal epinephrine delivery system was recently approved by the US Food and Drug Administration; however, published information on its real-world use is limited. Immunotherapy patients reacting in our clinic experienced prompt symptom resolution with neffy, highlighting its viability as an alternative to intramuscular injection in managing anaphylactic reactions."

Journal • Allergy • Immunology

Survey of patients who were prescribed epinephrine nasal spray (ACAAI 2025) - "Among the 14 current users, 93% of respondents reported that they were likely to refill epinephrine nasal spray and 86% said they were satisfied with epinephrine nasal spray; no patients reported dissatisfaction. Conclusion Although access immediately after the initial launch was limited, resulting in a small number of respondents, early data suggest that patients report a positive experience."

Clinical • Immunology • Pediatrics

Real world needle-free epinephrine experience in an allergy clinic (ACAAI 2025) - "Discussion This novel intranasal epinephrine worked in a timely manner with minimal side effect and distress to our patients in real-world scenarios. We expect this needle-free option to grow in popularity and use by eliminating one significant barrier, needle phobia, to early epinephrine administration."

Clinical • Real-world • Real-world evidence • Allergy • Immunology

Low risk of ocular toxicity after unintentional exposure of epinephrine nasal spray (ACAAI 2025) - "Conclusion A single topical administration of epinephrine nasal spray (10 mg/mL) in rabbit eyes was not associated with any adverse effects, indicating a low risk of ocular toxicity. These results support the safety of epinephrine nasal spray in the event of unintentional ocular exposure and taken together with epinephrine’s use in other ocular formulations, suggest that no further nonclinical ocular studies are necessary."

Ophthalmology

Rationale for second dose of epinephrine nasal spray to the same nostril (ACAAI 2025) - "Conclusion Across multiple nasal conditions, mean epinephrine C max via repeated doses of intranasal epinephrine were comparable to or greater than repeated IM injections, suggesting that intranasal epinephrine is an effective first-line therapy for treatment of severe allergic reactions/anaphylaxis. When intranasal epinephrine was administered during rhinitis, both same and opposite nostril administration resulted in plasma epinephrine levels that were greater than IM injection, however repeated administration to the same nostril optimized absorption."

Allergic Rhinitis • Immunology • Inflammation

Effect of sniff after dosing of epinephrine nasal spray (ACAAI 2025) - "Sniffing during or after self-administration of intranasal epinephrine 2 mg resulted in plasma epinephrine concentrations that were higher than IM injection, suggesting that sniffing will not have any impact on efficacy. Regardless, patients should not be instructed to repeat dosing if the patient sniffs but to follow standard instructions and administer a second dose if symptoms do not improve."