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

Intranasal Adrenaline Use for the Management of Insect Venom-Induced Anaphylaxis. (PubMed, Med J Aust) - "We report three cases of intranasal adrenaline (neffy, CSL Seqirus, Victoria, Australia) used to treat insect venom-induced anaphylaxis. Clinicians should be aware of the availability and current level of evidence for intranasal adrenaline for anaphylaxis management."

Journal

Product Theater 4 (non-CME) - ARS Pharmaceuticals Operations, Inc. : neffy®: Redefining Epinephrine Delivery in Anaphylaxis (ACAAI 2026) - "Sponsored by ARS Pharmaceuticals Description Join us to explore the latest in anaphylaxis treatment and the introduction of neffy, the first and only FDA-approved needle-free epinephrine nasal spray. Also visit ARS Pharmaceuticals Operations, Inc. at Booth #900."

Model-Informed Dose Selection of Intranasal Epinephrine in Young Children. (PubMed, J Clin Pharmacol) - "Simulations indicated that the pediatric doses of 2 mg (≥30 kg) and 1 mg (15-<30 kg) achieved exposure comparable to the adult 2 mg reference, supporting the dosing strategy. Model-informed simulations support weight-based IN epinephrine dosing in young children, addressing a critical gap in anaphylaxis management."

Journal • Allergy • Pain • Pediatrics

An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: ARS Pharmaceuticals, Inc. | Trial completion date: Jun 2026 ➔ Jun 2027 | Trial primary completion date: Jun 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Successful administration of neffy (epinephrine nasal spray) by patients and caregivers - Five human factor studies. (PubMed, Ann Allergy Asthma Immunol) - "These HF studies demonstrate that iterative development and validation of the IFU and QRG resulted in instructions that support reliable and correct administration of neffy across diverse user populations, including adolescents and untrained bystanders. The final FDA-approved labeling was used successfully without dosing errors and supports safe, effective, and repeat administration of intranasal epinephrine in emergency settings."

Journal • Allergy • Immunology

Neffy nasal spray will be listed to treat children over 4 and adults at significant risk of anaphylaxis (Australian Government Department of Health) - "Neffy is a new form of adrenaline (epinephrine) for the emergency treatment of acute severe allergic reactions in children over 4 years and 15 kg, and adults at significant risk of anaphylaxis. In 2025, around 150,300 patients accessed a comparable treatment through the PBS. Without PBS subsidy, patients could pay more than $95 per pack."

Reimbursement • Allergy

Stability of epinephrine nasal spray under room temperature, freeze-thaw, and extreme temperature conditions. (PubMed, J Allergy Clin Immunol Pract) - No abstract available

Journal

Clinical Advancement of Intranasal Epinephrine Program (GlobeNewswire) - "ARS Pharma’s Phase 2b trial (NCT06927999) evaluating its intranasal epinephrine technology as a treatment for acute flares of chronic spontaneous urticaria continues to enroll patients across the U.S. and Europe. The interim analysis population is fully enrolled, with interim data anticipated in the fourth quarter of 2026, followed by the potential initiation of a single Phase 3 pivotal efficacy study in mid-2027."

New P3 trial • P2b data • Chronic Spontaneous Urticaria • Immunology

ARS Pharmaceuticals Reports First Quarter 2026 Financial Results and Corporate Update (The Manila Times) - “Q1 2026 total revenue of $22.7 million including neffy (epinephrine nasal spray) U.S. net product revenue of $17.5 million; Phase 2b CSU study interim population fully enrolled, and on track for Q4 2026 readout; Commercial launch by ALK is expected later in 2026…potential initiation of a single Phase 3 pivotal efficacy study in mid-2027.”

Financing • Launch Canada • New P3 trial • P2b data • Allergy • Chronic Spontaneous Urticaria

Low risk of ocular toxicity following topical ocular administration of epinephrine nasal spray: implications for unintentional exposure. (PubMed, Allergy Asthma Clin Immunol) - "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."

Journal • Ophthalmology

Adrenaline (epinephrine) nasal spray for severe allergic reactions. (PubMed, Aust Prescr) - No abstract available

Journal • Review • Allergy

Neffy: A latest needle-free epinephrine. (PubMed, Saudi J Anaesth) - "Neffy (ARS-1; epinephrine nasal spray) introduces a needle-free, intranasal route for epinephrine delivery. This review examines the clinical evidence, pharmacological profile, indications, and safety data for Neffy and discusses implications for clinical practice."

Journal • Review • Allergy

neffy (epinephrine nasal spray) Approved in Canada as the First and Only Needle-Free Emergency Treatment of Allergic Reactions (anaphylaxis) (GlobeNewswire) - "ARS Pharma will be responsible for manufacturing and supplying neffy to ALK in Canada and expects neffy to be available in the summer of 2026. ARS Pharma anticipates filing for approval of neffy 1 mg dose for children greater than 15 kg and less than 30 kg with Health Canada by this summer."

Canada approval • Canada filing • Launch Canada • Allergy

Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy (clinicaltrials.gov) - P4 | N=600 | Recruiting | Sponsor: ARS Pharmaceuticals, Inc. | Trial completion date: Jun 2026 ➔ Jun 2027 | Trial primary completion date: Apr 2026 ➔ Apr 2027

Trial completion date • Trial primary completion date • Allergy

EURneffy 1 mg approved across the EU as the first and only needle-free adrenaline treatment for young children (≥15 kg) at risk of anaphylaxis (The Manila Times) - "This approval extends the existing marketing authorisation for EURneffy 2 mg, granted by the EC in August 2024 for the emergency treatment of anaphylaxis in adults and children weighing ≥30 kg...This approval applies to all 27 European Union (EU) member states, Iceland, Norway and Liechtenstein."

EMA approval • Allergy

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