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

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."

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

Product Theater 4 (non-CME) - ARS Pharmaceuticals, Inc. : Be neffy® Ready (ACAAI 2025) - "Description Introducing neffy, the first and only FDA-approved needle-free epinephrine nasal spray for type I allergic reactions, including anaphylaxis. Also visit ARS Pharmaceuticals, Inc. at Booth #400 ."

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. | Not yet recruiting ➔ Recruiting

Enrollment open • Allergy

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

Hello neffy (epinephrine nasal spray). Goodbye needles (AAP-NCE 2025) - "Sponsored By ARS Pharmaceuticals Operations, Inc."

neffy (epinephrine nasal spray) Approved in Japan as the First and Only Needle-Free Emergency Treatment of Allergic Reactions (anaphylaxis) (GlobeNewswire) - "Alfresa expects neffy to be available in the fourth quarter of 2025."

Japan approval • Launch Japan • Allergy

Regulatory approvals for neffy in Canada (with ALK), Australia and New Zealand (in partnership with CSL), are expected by the end of 2025, with commercial rollouts planned for early 2026. As well, regulatory approval for neffy in China (in partnership with Pediatrix) is expected in the first half of 2026. (GlobeNewswire)

Approval • Launch • Allergy

The Drug Update: Recent drug approvals, summer 2025 edition. (PubMed, Nurse Pract) - "This article highlights the following new medications: donanemab-azbt (Kisunla), nalmefene injection (Zurnai), epinephrine nasal spray (neffy), palopegteriparatide (Yorvipath), xanomeline and trospium chloride (Cobenfy), and sulopenem etzadroxil/probenecid (Orlynvah). Additionally, this article highlights the recent approval of obstructive sleep apnea as a new indication for tirzepatide (Zepbound) and chronic obstructive pulmonary disease as a new indication for dupilumab (Dupixent)."

Journal • Addiction (Opioid and Alcohol) • Allergy • Alzheimer's Disease • Chronic Obstructive Pulmonary Disease • CNS Disorders • Endocrine Disorders • Hypoparathyroidism • Immunology • Obstructive Sleep Apnea • Psychiatry • Pulmonary Disease • Respiratory Diseases • Schizophrenia • Sleep Disorder

Neffy and Narcan nasal sprays: potential for look-alike, sound-alike medication errors. (PubMed, Am J Nurs) - No abstract available

Journal

FDA approves neffy nasal spray for treatment of anaphylaxis in adult and pediatric patients. (PubMed, Ann Med Surg (Lond)) - No abstract available

FDA event • Journal • Pediatrics

MHRA approves adrenaline nasal spray - the first needle-free emergency treatment for anaphylaxis in the UK (GOV.UK) - "The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 18 July 2025, approved adrenaline (epinephrine) nasal spray (EURneffy) to be used for the emergency treatment of serious allergic reactions, known as anaphylaxis....It is intended for use in adults and children who weigh 30 kg (about 66 pounds) or more."

MHRA approval • Allergy

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

Parental perspectives on nasal adrenaline spray for the acute management of anaphylaxis: an international survey (EAACI 2025) - "Effectiveness of ANS for anaphylaxis, and how this compares to AAI, appears to be a critical information gap which needs to be addressed through research to inform shared decision making. Future work should also assess the views of children and young people with respect of ANS and alternative routes for adrenaline administration."

Late-breaking abstract • Food Hypersensitivity • Immunology

Pharmacokinetics and Pharmacodynamics following repeat dosing of ARS-1 (adrenaline nasal spray) versus intramuscular injection during induced allergic rhinitis: sub-analysis (EAACI 2025) - "Conclusion During SAR conditions, the pharmacokinetics and pharmacodynamics of two doses of ARS-1 (right/right or right/left) were similar to or better than IM. These findings suggest that for the approximately 10% of patients who require a second dose of adrenaline, ARS-1 will be a safe and effective treatment, even when administered during periods of very symptomatic allergic rhinitis."

PK/PD data • Allergic Rhinitis • Immunology • Inflammation

NEFFy: A Versatile Tool for Computing the Number of Effective Sequences. (PubMed, Bioinformatics) - "To ensure users can fully leverage these capabilities, comprehensive documentation and examples are provided at https://Maryam-Haghani.github.io/NEFFy. Supplementary data are available at Bioinformatics online."

Journal

In brief: Epinephrine 1 mg nasal spray (neffy). (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

ARS Pharmaceuticals Announces Co-Promotion Agreement with Partner and Global Allergy Leader ALK-Abelló A/S to Expand Reach of neffy (epinephrine nasal spray) to Additional U.S. Pediatricians (GlobeNewswire) - "Agreement builds on landmark licensing deal between ARS Pharma and ALK-Abelló A/S, which provided ARS Pharma with $145 million upfront and ALK with commercialization rights to neffy in Canada, United Kingdom, European Union and certain other countries outside the United States....the only approved needle-free treatment for Type I allergic reactions including anaphylaxis, to up to 9,000 pediatricians. This agreement accelerates ARS Pharma’s efforts to reach these key prescribers prior to the back-to-school season....Under the terms of the four-year deal, ARS Pharma will recognize all U.S. revenue and continue to have sole responsibility for all U.S. commercialization activities including marketing, medical affairs, market access, production, distribution, pharmacovigilance, quality and safety."

Licensing / partnership • Allergy