FDA Approves ARS Pharma’s Neffy Nasal Spray for 15-30 kg Patients

A Game-Changer for Pediatric Allergic Reaction Treatment

The U.S. Food and Drug Administration recently greenlit an expanded application of ARS Pharmaceuticals’ innovative nasal spray, neffy, tailored for patients weighing between 15 and 30 kilograms. This groundbreaking approval introduces a 1 milligram dose specifically designed for this weight range, broadening access to a needle-free epinephrine solution previously reserved for individuals over 30 kilograms with a 2 milligram dose. Known as neffy, this allergic reaction nasal spray stands out as a revolutionary alternative to traditional epinephrine autoinjectors like EpiPen, offering a portable, user-friendly option for managing life-threatening allergic emergencies such as anaphylaxis. With shares of ARS Pharmaceuticals climbing 5.2% in after-hours trading following the announcement, the move signals strong market confidence in this expanded use of neffy for severe allergic reaction treatment.

This approval marks a pivotal moment for pediatric patients, particularly children weighing 33 to 66 pounds, who are now eligible for this cutting-edge treatment. Anaphylaxis, a rapid and potentially fatal allergic response triggered by allergens like food, medications, or insect stings, demands immediate intervention. Neffy delivers epinephrine through the nasal passage, bypassing the need for injections, which can be daunting for young children and their caregivers. Analysts, including Raymond James’ Ryan Deschner, note that while this 15-30 kg demographic represents roughly 15% of neffy’s overall market, it accounts for a significant share of demand, especially among parents seeking a less intimidating option for their kids. The compact design of this epinephrine nasal spray for anaphylaxis, easily tucked into a pocket, eliminates the hassle of lugging around bulkier autoinjectors, making it a practical choice for families on the go.

ARS Pharmaceuticals has positioned neffy as a transformative tool in allergy management since its initial FDA approval in August 2024 for heavier patients. The latest decision builds on that foundation, with the company anticipating the 1 milligram version’s availability in the U.S. by late May 2025. Priced at $199 for two doses, mirroring the cost of the 2 milligram variant, neffy remains competitively priced, according to CEO Richard Lowenthal. This pricing strategy ensures affordability for families seeking an effective severe allergic reaction treatment without needles. Moreover, the timing of this expanded approval aligns with the back-to-school season in August, a peak period for epinephrine purchases, which could drive a surge in prescriptions as parents prepare their children for classroom environments where allergen exposure risks often rise.

Beyond its immediate impact, this development underscores ARS Pharmaceuticals’ commitment to innovation in allergy care. The company is already exploring a lower dose paired with a modified sprayer for even smaller children, hinting at future expansions that could further solidify neffy’s role in pediatric anaphylaxis treatment. The nasal spray’s ease of use is a standout feature, potentially reducing hesitation during emergencies, a common issue with needle-based autoinjectors. For instance, studies suggest that caregivers and even school staff may delay or avoid using injectors due to fear or unfamiliarity, whereas neffy’s straightforward nasal delivery could streamline response times, offering peace of mind to those managing severe allergies in young children.

From a market perspective, the expanded use of neffy for 15-30 kg patients opens new revenue streams for ARS Pharmaceuticals. The 5.2% stock uptick reflects investor optimism about the nasal spray’s growth potential, particularly as it taps into a niche yet vocal segment of the allergy treatment market. Deschner highlights that this approval could accelerate neffy’s adoption, especially as awareness spreads among pediatricians and parents seeking alternatives to traditional epinephrine delivery methods. The portability and simplicity of this allergic reaction nasal spray also cater to modern lifestyles, where convenience and quick access to emergency tools are increasingly valued.

Looking ahead, neffy’s expansion into the 15-30 kg weight range could reshape how severe allergic reactions are managed in younger populations. By offering a needle-free epinephrine nasal spray for anaphylaxis, ARS Pharmaceuticals addresses a critical need for accessible, less invasive treatments. The company’s ongoing efforts to refine dosages and delivery systems suggest a long-term vision of covering all age and weight groups, potentially challenging the dominance of autoinjectors in the allergy treatment landscape. For now, families and healthcare providers can anticipate the arrival of the 1 milligram neffy by May 2025, bringing a fresh layer of confidence to managing allergic emergencies in children weighing 15 to 30 kilograms. This milestone not only enhances patient care but also positions ARS Pharmaceuticals as a forward-thinking leader in the fight against anaphylaxis.