FDA Approves ARS Pharmaceuticals’ neffy for Type 1 Allergic Reactions in Pediatric Patients
The approval of neffy marks the first major advancement in epinephrine delivery for patients over four years of age in more than 35 years.
Image Credit: Adobe Stock Images/Steveandfriend
The FDA has approved ARS Pharmaceuticals’ neffy 1 mg, an epinephrine nasal spray, for type 1 allergic reactions, including anaphylaxis, in pediatric patients over four years of age who weigh between 33 lbs. and 66 lbs. According to the company, this marks the first major advancement in epinephrine delivery for pediatric patients in over 35 years.1
“Today’s FDA approval of neffy 1 mg marks a major milestone towards our efforts to transform the management of severe allergic reactions,” says Richard Lowenthal, co-founder, president, and CEO of ARS Pharma. “Many children and caregivers fear needle-based auto-injectors, which can delay lifesaving treatment. neffy’s needle-free, easy-to-use design addresses this unmet need, offering families a long-awaited alternative. With nearly four out of 10 US epinephrine prescriptions written for children under the age of 18—and nearly a third of those for children weighing 15 to 30 kilograms4 —we believe neffy 1 mg will improve access to a needle-free option for the treatment of severe allergies and reduce hesitation in treating this vulnerable group. It will also eliminate risks like accidental needle injuries to children or caregivers.”
Clinical trial results determined that neffy delivers epinephrine with pharmacokinetic and pharmacodynamic responses comparable to injections. All reported adverse events (AEs) were considered to be mild and transient. Common AEs include nasal discomfort; headache; throat irritation; chest and nasal congestion; feeling overly excited, nervous or anxious; nose bleed; nose pain; sneezing; runny nose; dry nose or throat; tingling sensation in the nose; drowsiness; dizziness; nausea; and vomiting.
According to ARS, the device is designed for ease of use, allowing even untrained individuals to administer it effectively. Additionally, it has a shelf-life of 24 months and is resilient to temperature variations.1
The FDA first approved neffy in August 2024 for adults and pediatric patients who weigh 66 lbs. or more, based on results from four studies in healthy adults without anaphylaxis, measuring epinephrine concentrations in the blood following administration of neffy or approved epinephrine injection products. The studies found that neffy demonstrated epinephrine blood concentrations similar to previously approved epinephrine injection products.2
According to Food Allergy Research & Education, 33 million people in the United States are currently living with food allergies, including 42% of children and 51% of adults. Additionally, an estimated 40% of children in the United States have multiple food allergies.3 According to ARS, around 40% of patients hold back on treatment and around 56% of caregivers are hesitant to treat children with needle-based auto-injectors.1
“The availability of a needle-free epinephrine option for children is a breakthrough in the treatment of severe allergic reactions,” says David Fleischer, section head, Allergy & Immunology, professor of pediatrics, Children’s Hospital Colorado, in the press release. “Many people wait to administer epinephrine until symptoms progress or take antihistamines as a first line of defense because they are afraid of injection. neffy’s small, user-friendly design addresses these challenges, empowering people to actually carry epinephrine and act quickly and confidently during an allergic emergency. This innovation will likely significantly improve health outcomes and enhance quality of life.”
ARS expects neffy 1 mg to be available in the United States by May 2025, with affordability initiatives ensuring broad patient access, including a $25 co-pay for most commercially insured patients and assistance programs for uninsured patients.1
References
1. 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 Pharma. 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
2. Facts and Statistics. FARE. Accessed March 6, 2025. https://www.foodallergy.org/resources/facts-and-statistics
3. FDA Approves First Epinephrine Nasal Spray for Type I Allergic Reactions Including Anaphylaxis. PharmExec. August 9, 2024. Accessed March 6, 2025. https://www.pharmexec.com/view/fda-approves-first-epinephrine-nasal-spray-type-i-allergic-reactions-anaphylaxis
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