FDA Approves Needle-Free Allergy Treatment for Kids
The US Food and Drug Administration (FDA) has approved Neffy, a nasal spray for treating severe allergic reactions in children aged 4 and above. This is the first emergency allergy treatment that doesn’t require a needle, making it easier and quicker to use.
This approval represents the first significant innovation in the delivery of epinephrine for this patient population in more than 35 years.
In the general population, approximately one in 13 children have severe food allergies, and more than 40 percent have experienced severe reactions. Despite the clear link between early epinephrine use and better outcomes, research shows that approximately 40 percent of patients delay treatment, and 56 percent of caregivers fear using needle-based auto-injectors on their child. neffy eliminates needles, delivering a precise epinephrine dose via a simple nasal spray, almost instantly, with no nasal hold time required.
“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 U.S. 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.”
The approval of neffy 1 mg is based on data from extensive clinical trials, including pharmacokinetic (PK) and pharmacodynamic (PD) responses in pediatric and adult subjects that were consistent with those of epinephrine injection products. Adverse events in pediatric trials were generally mild and transient. Human factor studies also show children as young as 10 can use neffy effectively by following instructions, and that even untrained individuals, such as babysitters or teachers, can effectively administer neffy. The device has a shelf-life of 24 months at room temperature and tolerance to temperature exposures up to 122°F (50°C) based on testing for up to 3 months. If accidentally frozen, neffy can be thawed without impact on the product quality and reliability.
“The availability of a needle-free epinephrine option for children is a breakthrough in the treatment of severe allergic reactions,” says Dr. David Fleischer, Section Head of Allergy & Immunology, and Professor of Pediatrics, at Children’s Hospital Colorado. “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 Pharma is committed to access and affordability, and neffy 1 mg is expected to be available in the U.S. by the end of May 2025. The neffyConnect program provides patients, caregivers, and healthcare professionals with information to guide their treatment journey, details about medication fulfillment services, financial support and navigating insurance requirements. Most commercially insured patients will pay no more than $25 for two single-use neffy devices through a co-pay savings program. The co-pay savings card can be accessed at neffy.com and downloaded to an Apple Wallet and provided to the pharmacy. If the product isn’t covered by insurance, the cash price of $199 for two doses is available through BlinkRx and coupon can be downloaded from GoodRx for use at local retail pharmacies. For certain uninsured or underinsured U.S. residents meeting eligibility criteria and exhausted all other options, the ARS Pharma Patient Assistance Program (PAP) will provide neffy at no cost.
Eligible schools participating in the neffyinSchools program can receive neffy 1 mg upon availability.
The approval of neffy 1 mg follows FDA approval for neffy 2 mg on August 9, 2024 for children and adults weighing 30kg ( 66 lb.), and approval for EURneffy in the EU by the European Commission on August 22, 2024.
About neffy
neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs. or greater.
About Type I Allergic Reactions Including Anaphylaxis
Type I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine auto-injectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I Allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector. Even if patients or caregivers carry an auto-injector, more than half either delay or do not administer the device when needed in an emergency.
