Colleen Kraft, MD, is a clinical professor of Pediatrics at the Keck School of Medicine of USC and an attending physician at the Children’s Hospital Los Angeles.

Colleen Kraft, MD, MBA

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.

In this video, part 5 of a 5-part series, panelists discuss emerging innovations in food allergy and anaphylaxis research poised to reshape clinical practice.

RX Review: Innovations in Food Allergy and Anaphylaxis Research

, Brian Schroer, MD, moderates a forward-looking discussion with Colleen Kraft and Russell Traister on emerging innovations in food allergy and anaphylaxis research poised to reshape clinical practice.

Traister highlights the potential of novel therapies, including patch-based immunotherapy and the combination of biologics like omalizumab (Xolair) with oral immunotherapy (OIT). He raises key questions about how these therapies might be sequenced or combined to optimize treatment.

Kraft emphasizes the promise of these treatments not only for food allergy but also for related allergic conditions like asthma and atopic dermatitis, offering broader benefits for children and their families. She also notes the accessibility challenges, acknowledging that while OIT may be less costly than biologics, its time-intensive nature makes it less feasible for primary care settings—posing barriers to care.

Schroer points to the growing momentum around early immunotherapy, especially for young children under four, which shows potential for raising allergy thresholds and, in some cases, helping children outgrow allergies altogether. He also highlights the need for improved implementation of early allergen introduction strategies.

The panel closes by stressing that advances in food allergy care have far-reaching impacts—helping children attend school, parents return to work, and families live with less anxiety over severe allergic reactions.


Part 1: RX Review: Advances in Pediatric Food Allergy and Anaphylaxis Management

Part 2: RX Review: Addressing Unmet Needs in Pediatric Food Allergy Research

Part 3: RX Review: Needle-Free Epinephrine and Emerging Food Allergy Treatments

Part 4: RX Review: Closing Gaps in Clinician Education on Food Allergies

 is an allergist immunologist at the Cleveland Clinic Children's Hospital. Board-certified in internal medicine, pediatrics, and allergy and immunology, Schroer serves as the moderator for this panel discussion.

 is a clinical professor of Pediatrics at the Keck School of Medicine of USC and an attending physician at the Children’s Hospital Los Angeles. In addition to these roles, Kraft is also the former president of the American Academy of Pediatrics.

 is a pediatric allergy and immunology specialist at Allegheny Health Network’s Pediatric Institute. Board-certified in allergy, immunology, and internal medicine, Traister serves as the third panelist for our discussion.

Relevant disclosures for Schroer include Genzyme, AstraZeneca, Amgen, GSK, and Sobi. Relevant disclosures for Kraft include Sanofi and Sobi. Relevant disclosures for Traister include Abbvie.

In this video, part 4 of a 5-part series, panelists discuss gaps in clinician education regarding food allergies and anaphylaxis.

RX Review: Closing Gaps in Clinician Education on Food Allergies

Contemporary Pediatrics RX Review Special Report

, Brian Schroer, MD, moderates a discussion with Colleen Kraft, MD, and Russell Traister, MD, on gaps in clinician education regarding food allergies and anaphylaxis.

Kraft highlights key educational gaps, including distinguishing IgE-mediated and non-IgE-mediated allergies, understanding when to refer for oral or injectable immunotherapy, and managing mixed allergic conditions like atopic dermatitis and eosinophilic esophagitis. She stresses the need for primary care providers to move beyond the outdated belief that food allergies are lifelong and unchangeable.

Traister focuses on the lingering confusion surrounding early allergen introduction, emphasizing that while most providers now accept the benefits—following the 2015 LEAP study—many still lack practical guidance on how to safely introduce allergens like tree nuts or eggs to infants. He also notes the inconsistency in food allergy testing, where unnecessary proprietary panels often lead to misinterpretations and over-restriction of children’s diets, risking malnutrition.

The panel agrees that a major issue is the misuse of broad food allergy panels without allergist input. Schroer and Traister stress that negative tests generally rule out anaphylaxis risk, but positive results don't confirm allergies without proper clinical history—reinforcing the need for history-driven, evidence-based allergy care.

Part 5: RX Review: Innovations in Food Allergy and Anaphylaxis Research

In this video, part 3 of a 5-part series, panelists discuss on how needle-free epinephrine and evolving therapies are reshaping food allergy management.

RX Review: Needle-Free Epinephrine and Emerging Food Allergy Treatments

, Brian Schroer, MD, leads a discussion with Colleen Kraft, MD, and Russell Traister, MD, on how needle-free epinephrine and evolving therapies are reshaping food allergy management.

Traister highlights that while epinephrine nasal spray (neffy) offers a less invasive option, its suitability depends on patient preferences—some children may resist nasal sprays just as strongly as needles. He stresses the importance of individualized discussions with families.

Kraft adds that beyond emergency care, the emergence of oral immunotherapy (OIT) and biologics like omalizumab (Xolair) are breaking the misconception that food allergies can only be managed through avoidance. She notes that children on omalizumab often experience reduced anxiety, empowering them to engage in social activities like school lunches and birthday parties with more confidence.

The panel discusses ideal candidates for omalizumab, including children with documented anaphylaxis, those with severe anxiety about accidental exposure, patients with multiple food allergies, and teenagers prone to risk-taking behaviors.

Editor's note: As of March 5, the FDA has expanded epinephrine nasal spray’s approval to treating type 1 allergic reactions in children as young as four years old, offering a new option for younger patients weighing 15 to less than 30 kg—equivalent to the junior dose of self-injectable epinephrine.


Colleen Kraft, MD, MBA

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