The nasal spray provides a needle-free alternative for pediatric patients weighing between 15 and 30 kilograms who are at risk for severe allergic reactions.
RT’s Three Key Takeaways:
- Pediatric Approval Expansion: The Food and Drug Administration (FDA) approved the 1 mg dose of neffy for children weighing 15 to < 30 kg, offering the first needle-free epinephrine delivery for this age group in over 35 years.
- Addressing Treatment Barriers: Research indicates that 56% of caregivers fear using needle-based injectors, a factor that contributes to nearly 40% of patients delaying lifesaving treatment during an emergency.
- Clinical Bioequivalence: The approval is supported by clinical trials showing pharmacokinetic and pharmacodynamic responses that are consistent with traditional epinephrine injection products.
The US FDA has approved neffy 1 mg (epinephrine nasal spray) for the treatment of Type I allergic reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to < 30 kg (33 to < 66 lb), according to ARS Pharmaceuticals Inc
This approval represents the first needle-free epinephrine treatment for this specific pediatric population. Approximately one in 13 children have severe food allergies, and more than 40% have experienced severe reactions, according to data cited in a company news release.
“Today’s FDA approval of neffy 1 mg marks a major milestone towards our efforts to transform the management of severe allergic reactions,” said Richard Lowenthal, co-founder, president, and CEO of ARS Pharma, in a news release. “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.”
Research cited by the company shows that 56% of caregivers fear using needle-based auto-injectors on their child, and approximately 40% of patients delay treatment. The nasal spray delivers a precise epinephrine dose via a simple device with no nasal hold time required.
“The availability of a needle-free epinephrine option for children is a breakthrough in the treatment of severe allergic reactions,” said Dr David Fleischer, section head of allergy and immunology and professor of pediatrics at Children’s Hospital Colorado, in a news 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.”
The approval was based on clinical trials demonstrating that the pharmacokinetic and pharmacodynamic responses in pediatric and adult subjects were consistent with those of epinephrine injection products. Adverse events in pediatric trials were generally mild and transient. Human factor studies also indicated that children as young as 10 can use the device effectively, and untrained individuals, such as teachers or babysitters, can also administer the dose successfully.
The device has a shelf life of 24 months at room temperature and can withstand temperature exposures up to 122°F (50°C). If the device is accidentally frozen, it can be thawed without impacting the product quality or reliability, according to the manufacturer.
ARS Pharmaceuticals expects neffy 1 mg to be available in the US by the end of May 2025. The company stated that most commercially insured patients will pay no more than $25 for two single-use devices through a co-pay savings program. For patients whose insurance does not cover the product, a cash price of $199 for two doses is available through specific pharmacy platforms. Additionally, the company will provide the medication at no cost to certain eligible uninsured or underinsured residents through a patient assistance program.
Image credit: ARS Pharma/Neffy via Finn Partners
