ARS Pharmaceuticals, Inc, a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced that the US Food and Drug Administration (FDA) has approved neffy 1 mg (epinephrine nasal spray) for the treatment of type I allergic reactions, including anaphylaxis, in children who are aged four years and older and weigh 15 to < 30 kilograms (33 to < 66 lb). 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 per cent have experienced severe reactions. Despite the clear link between early epinephrine use and better outcomes, research shows that approximately 40 per cent of patients delay treatment, and 56 per cent 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 US 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 ten US epinephrine prescriptions written for children under the age of 18 - and nearly a third of those for children weighing 15 to 30 kilograms — 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 and pharmacodynamic 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 US by the end of May 2025. The neffyConnect programme 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 programme. 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 US residents meeting eligibility criteria and exhausted all other options, the ARS Pharma Patient Assistance Programme will provide neffy at no cost.
The approval of neffy 1 mg follows US FDA approval for neffy 2 mg on August 9, 2024 for children and adults weighing 30 kg, and approval for EURneffy in the EU by the European Commission on August 22, 2024. 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.