ARS Pharmaceuticals is seeking to expand the availability of Neffy, its epinephrine nasal spray, to younger pediatric patients. The company has submitted a supplemental New Drug Application (sNDA) to the FDA for Neffy 1 mg, targeting the treatment of type 1 allergic reactions, including anaphylaxis, in children weighing between 33 and 66 pounds (15-30 kg). This follows the FDA's approval of Neffy 2 mg in August 2024 for adults and children weighing 66 pounds or more.
Addressing Needle Phobia in Pediatric Allergy Treatment
A key advantage of Neffy 1 mg is its needle-free administration, which Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharmaceuticals, emphasized as a significant benefit for younger, school-aged children. "Fear of needles is a common reason children refuse treatment with auto-injectors," Lowenthal stated. Given that nearly half of all epinephrine auto-injector prescriptions are for children, and more than half of those are for children weighing 33 to 66 pounds, there is a substantial need for innovative, less intimidating treatments.
Benefits of Needle-Free Administration
Neffy 1 mg aims to eliminate the risk of needle-related injuries, which occur approximately 3,500 times each year in the U.S. with epinephrine injection devices, disproportionately affecting pediatric patients. Human factor studies demonstrated that adults without prior knowledge of the device could successfully administer it by simply reading the instructions. Moreover, untrained children as young as 10 years old were able to self-administer Neffy, highlighting its ease of use.
Convenient Design and Temperature Stability
Neffy's design also offers practical advantages. Its small size allows it to be easily carried in a pocket, purse, or backpack. Additionally, Neffy can withstand temperature exposure up to 122°F (50°C) and can be thawed and administered if accidentally frozen, providing greater reliability in various conditions.
Ongoing Development and Commitment to Accessibility
ARS Pharmaceuticals is also advancing its nasal spray development program across multiple type 1 hypersensitivity reactions, including acute flares of urticaria. The company is committed to ensuring access and affordability for all patients who need Neffy through its NeffyConnect program, which guides patients and caregivers through copay savings, insurance coverage support, and affordable pricing options. For commercially insured patients, Neffy is available for $25 for two single-use devices. Patients with high deductible plans or no insurance coverage can expect to pay $199 out of pocket for two doses. Neffy will be provided free of charge for patients who have exhausted all other options.
Manufacturing and Commercialization
Renaissance Lakewood, LLC, a global CDMO, manufactures Neffy. Their partnership with ARS Pharmaceuticals has spanned every stage of development, from initial research and clinical trials to full-scale manufacturing and commercialization. To meet global market demands, Renaissance has expanded its campus and invested in additional packaging lines.
Expert Opinions
Eleanor Garrow-Holding, President and CEO of the Food Allergy & Anaphylaxis Connection Team (FAACT), emphasized the importance of this innovation: "There is no doubt that this innovation is going to save lives. Patients need options, and Neffy is helping to solve that issue."
