Thomas B. Casale, MD

One Year Later: How Intranasal Epinephrine Is Changing Emergency Allergy Treatment

On August 9, 2024, the FDA approved the first needle-free epinephrine nasal spray under the name neffy (ARS Pharmaceuticals) for the emergency treatment of anaphylaxis in adults and children—a significant milestone in allergy care.

 One year later, this intranasal option has expanded the treatment landscape for severe allergic reactions, offering a discreet and easy-to-use alternative to autoinjectors. For many patients, especially children or those with needle aversion, this innovation represents not just convenience, but potentially life-saving accessibility.

Over the past year, clinicians have gained real-world experience with intranasal epinephrine, now approved for use in patients as young as 4 years old and weighing between 15 to <30 kg, following an FDA expansion in March 2025.

 While some access barriers remain typical for newly approved therapies, early adoption has been encouraging, with over 5,000 prescriptions written since approval, although data is not available regarding how many have actually been filled.

This first year has offered an opportunity to assess insurance coverage patterns, patient adherence, and clinician comfort in prescribing a new route of epinephrine delivery. As more needle-free options enter the pipeline, continued education for clinicians will be critical to ensure familiarity with evolving treatment modalities and appropriate patient selection. 

Overall, in its first year since coming to market, nasal epinephrine seems to be an invaluable addition to the anaphylaxis treatment landscape. Long-term data will continue to validate patient use.

Brief descriptions of the speakers featured in this project are provided below:

CMO of Asthma and Allergy Foundation of America (AAFA), former professor at Childrens' Hospital Colorado and University of Colorado

Allergist immunologist at the Cleveland Clinic Children's Hospital

Clinical professor of Pediatrics at the Keck School of Medicine of USC and an attending physician at the Children’s Hospital Los Angeles

 Vice President of Pharmacy at Emory Healthcare and Winship Cancer Institute

Professor of Medicine at University of South Florida in Tampa

The video states neffy 2 mg is approved for adults or children weighing ≥ 66 pounds. However, neffy 2mg is approved for adults and children weighing ≥ 66 pounds, and the 1 mg version is approved for patients aged ≥ 4 years who weigh between 33 and 66 pounds.

Office of the Commissioner. FDA approves first nasal spray for treatment of anaphylaxis. U.S. Food and Drug Administration. August 9, 2024. Accessed August 9, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis.
ARS Pharmaceuticals. 

Ars Pharmaceuticals announces FDA approval of neffy® 1 mg (epinephrine nasal spray) for type I allergic reactions, including anaphylaxis, in pediatric patients weighing 15 to 30 kilograms. ARS Pharmaceuticals. March 5, 2025. Accessed March 6, 2025. 

https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-announces-fda-approval-neffyr-1-mg

ARS Pharmaceuticals Reports First Quarter 2025 Financial Results and Highlights Progress in U.S. Commercial Launch of neffy® (epinephrine nasal spray). News release. ARS Pharmaceuticals. May 14, 2025. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-reports-first-quarter-2025-financial-results

Videos

One year after neffy's approval, 4 clinicians and 1 PharmD examine its continuing impact on the field.

Casale discussed data from the phase 3 LIBERTY-CSU CUPID studies evaluating dupilumab’s use in urticaria.

Phase 3 Data Supports Dupilumab’s Approval for CSU, with Thomas Casale, MD

Dupilumab (Dupixent) reduced itch and urticaria activity in patients with chronic spontaneous urticaria (CSU) who were uncontrolled with H1-antihistamines, regardless of body mass index (BMI).

These findings, from the phase 3 LIBERTY-CSU CUPID Study A and Study C (NCT04180488), were presented at the 

2025 American Academy of Allergy, Asthma, and Immunology/World Allergy Organization Joint Congress

, February 28-March 3, in San Diego, California, by Thomas Casale, MD, professor of internal medicine at Morsani College of Medicine, University of South Florida.

 spoke with Casale to learn more about dupilumab, which is up for FDA review for CSU with a target action date of April 18, 2025.

Casale went over the safety and efficacy data seen in the studies, as well as a subgroup analysis that demonstrated no difference in improvements even at the upper limits of normal or in the obese range of BMI.

“I think this will give individuals some reassurance that this drug will work with chronic urticaria, and although not tracking as much with other T2-high disease, if you do have, for example, asthma, you are more likely to have urticaria than the normal population, and if you have a drug that can treat multiple comorbid conditions, I think that also makes a positive statement for the development program for dupilumab for urticaria,” Casale said.

Casale T, Saini S, Bernstein J, et al. Dupilumab Improves Itch and Urticaria Activity In Patients With Chronic Spontaneous Urticaria: Pooled Results From Two Phase 3 Trials (LIBERTY-CSU CUPID Study A and Study C). Late-breaking abstract presented at AAAAI 2025 in San Diego from February 28 – March 3.

Casale T, Maurer M, Gimenez-Arnau A, et al. Dupilumab Improves Signs And Symptoms Of Chronic Spontaneous Urticaria Regardless Of Baseline Body Mass Index. Presented at: AAAAI/WAO Joint Congress, San Diego; 2/28-3/3. Abstract 589.

Press Release: Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria. News release. Sanofi. November 15, 2024. Accessed March 6, 2025. https://www.sanofi.com/en/media-room/press-releases/2024/2024-11-15-06-00-00-2981756 

Casale discussed data from the phase 1b/2a BEACON study he presented at the AAAAI/WAO Joint Congress.

Investigating Briquilimab’s Efficacy and Safety for CSU, with Thomas Casale, MD

Briquilimab was well-tolerated and seemed to control disease in patients with chronic spontaneous urticaria (CSU) according to new data from the phase 1b/2a BEACON study (NCT06162728).

These findings were presented at the 2025 American Academy of Allergy, Asthma, and Immunology/World Allergy Organization Joint Congress, February 28-March 3, in San Diego, California, by Thomas Casale, MD, Professor, Internal Medicine, Morsani College of Medicine, University of South Florida.

® spoke with Casale to learn more about briquilimab, which is an aglycosylated antibody that potently inhibits SCF/c-Kit signaling and induces apoptosis of mast cells. He shared data he presented at the congress and why briquilimab may have potential as a treatment in people with CSU refractory to omalizumab. In terms of safety, he noted that due to briquilimab’s mechanism of action, some participants may experience hypogeusia, skin and hair color changes, and neutropenia, but no clinically significant changes were identified in the study.

“With the approval of omalizumab, that made a big difference, because a number of patients do respond and they get better, but there's always a caveat to that, and that is, there are certain patients that don't respond as well, and there are certain patients that respond, but it takes them a long time to respond, and in those patients, it's a very troubling problem for them… And I think having some options like briquilimab, which in this initial study, appears to work very rapidly and has a sustained relief, is a very good option,” Casale said.

Casale's disclosures include Sanofi, Genentech, Regeneron, Novartis, Jasper and Celldex.

Casale T, Majeed S, Tucker E, et al. Initial results from BEACON, a phase 1b/2a dose escalation study of the anti-c-Kit briquilimab antibody in adults with chronic spontaneous urticaria (CSU). Presented at: 2025 AAAAI/WAO Joint Congress, February 28-March 3. Abstract L24

Thomas B. Casale, MD

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