FDA Approves ARS Pharmaceuticals' Neffy Nasal Spray for Children with Anaphylaxis

The U.S. Food and Drug Administration (FDA) has granted approval for a 1-mg formulation of ARS Pharmaceuticals' epinephrine nasal spray, Neffy, for the treatment of type I allergic reactions, including anaphylaxis, in small children. This approval marks a significant milestone in pediatric allergy care, offering a needle-free alternative for young patients.

Neffy: A Breakthrough in Pediatric Anaphylaxis Treatment

Neffy 1 mg is now approved for use in pediatric patients aged 4 years and older who weigh at least 15 kg but less than 30 kg. According to ARS Pharmaceuticals, this nasal spray represents the "first significant innovation" in administering epinephrine to children in over 35 years.

The approval follows Neffy's initial FDA clearance in August 2024, which established it as the industry's first nasal spray for severe allergies. ARS Pharmaceuticals CEO Richard Lowenthal described the initial approval as "a watershed moment" for allergy care.

Lowenthal emphasized the importance of this latest approval, stating, "Many children and caregivers fear needle-based auto-injectors, which can delay lifesaving treatment. 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."

Accessibility and Pricing

ARS Pharmaceuticals plans to make Neffy available in pharmacies by the end of May 2025. The company has announced a co-pay savings program that will cap out-of-pocket costs at $25 for two single-use application devices for most commercially insured patients. Without insurance, the two doses of Neffy will be priced at $199.

Technical Details and Mechanism of Action

Neffy's nasal spray formulation contains ARS Pharma's proprietary epinephrine mixture, combined with the absorption agent dodecyl-maltoside, a well-established anti-allergy medication. The hormone therapeutic targets both alpha- and beta-adrenergic receptors, effectively relaxing the airways and tightening blood vessels to counter common anaphylaxis symptoms.

Advancements in Food Allergy Treatment

In related news, Roche's Genentech and development partner Novartis recently reported positive results for their asthma drug Xolair in treating food allergies. In a trial where patients were exposed to increasing amounts of allergens, Xolair outperformed oral immunotherapy. Following Xolair treatment, 36% of patients were able to tolerate at least 2,000 mg of peanut protein taken together with two other food allergens.

This success comes as welcome news for Novartis, which faced a setback in January 2024 when it terminated a Phase III trial for ligelizumab, a subcutaneous biologic therapy that was being positioned as a potential successor to Xolair. Novartis has since removed ligelizumab from its pipeline.