epinephrine low dose (ARS-2) / ARS Pharma - LARVOL DELTA

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

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

Journal

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

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

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

Incorrect perceptions of first-line treatment of severe allergic reactions with over-the-counter products and how the epinephrine drug delivery system impacts behavior. (PubMed, Allergy Asthma Proc) - " Despite potential risks of delaying using epinephrine, OTC medications are commonly used alone or before epinephrine use. Given the concerns about device needles identified in this survey, needle-free epinephrine offers an alternative to EAIs."

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

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."

Stability of epinephrine nasal spray under freeze thaw and extreme temperatures (ACAAI 2025) - "Conclusions Intranasal epinephrine potency was not affected by extreme temperature fluctuations (-20/-4 to 40°C/104°F) or by multiple freeze/thaw cycles and remained within specifications for potency under extreme temperature conditions after 3-months at 50°C/122°F or 6-months at 40°C/104°F. While intranasal epinephrine is unlikely to have reduced efficacy following exposure to extreme high or low temperatures that mimic real world exposures and boosting confidence in use throughout its 24 to 30-month shelf-life, patients/caregivers should always carry devices with them."

Anxiety and well-being related to intra-nasal epinephrine versus autoinjector in food allergic patients and caregivers (ACAAI 2025) - "Adults with needle-phobia (n=40) had significantly larger increase in well-being scores with IN access than EAI compared to those of adults who were not (n=160) (6.5/0.4, p<0.01). Conclusion Adult patients and caregivers expected to experience an improvement in their own anxiety or wellbeing when imagining access to nasal administration during acute episodes of severe allergic reactions."

Clinical • Food Hypersensitivity • Mood Disorders • Psychiatry

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. | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Epinephrine Nasal Spray Improves Allergic Symptoms in Patients Undergoing Oral Food Challenge, Phase 3 Trial. (PubMed, J Allergy Clin Immunol Pract) - "neffy successfully treated OFC-induced anaphylaxis symptoms. The availability of a needle-free epinephrine delivery device may reduce dosing hesitancy, particularly in patients who are fearful of injections."

Journal • P3 data • Allergy • Dermatology • Food Hypersensitivity • Immunology • Movement Disorders • Pediatrics

Effects of Induced Allergic Rhinitis on Endogenous Epinephrine. (PubMed, Ann Allergy Asthma Immunol) - No abstract available

Journal • Allergic Rhinitis • Immunology • Inflammation