FDA Authorizes ARS' Neffy 1mg for Children's Anaphylaxis

The US Food and Drug Administration (FDA) has given its approval to ARS Pharmaceuticals for their innovative product, neffy 1mg, a nasal spray designed to treat allergic reactions, including anaphylaxis, in children aged four and older who weigh between 15 kg and 30 kg. This marks a notable advancement in managing type one allergic reactions as it offers a needle-free alternative for administering epinephrine, which is traditionally delivered through injection.

Neffy’s unique delivery mechanism provides an immediate dose of epinephrine via nasal spray without requiring a hold period, simplifying the administration process significantly. The FDA's approval of this product is based on positive data from clinical trials. These trials demonstrated that the pharmacodynamic and pharmacokinetic responses of the nasal spray are comparable to those of conventional epinephrine injection products, which are commonly used to manage severe allergic conditions.

Richard Lowenthal, CEO, president, and co-founder of ARS Pharmaceuticals, expressed his enthusiasm about this development, stating that the approval of neffy 1mg represents a significant milestone in revolutionizing the treatment of severe allergic reactions. He highlighted the fact that nearly 40% of epinephrine prescriptions in the US are for children under 18, with a significant portion for those weighing 15 to 30 kilograms. Lowenthal believes that neffy 1mg will enhance accessibility to a needle-free option, alleviating hesitations in treating young patients and mitigating risks associated with accidental needle injuries to both children and caregivers.

This nasal spray is user-friendly, designed so that even individuals without formal medical training, such as teachers and babysitters, can administer it effectively by following the provided instructions. The product also boasts practical benefits like a two-year shelf life at room temperature. It can endure temperatures up to 122°F for three months and is resilient enough to be thawed without any degradation to its efficacy if accidentally frozen.

The approval for neffy 1mg follows an earlier FDA approval in August 2024 for a higher dose version, neffy 2mg, intended for use in children and adults weighing 30 kg and above. This approval was paralleled by the European Commission’s endorsement of EURneffy in the European Union, marking an expanding acceptance of ARS Pharmaceuticals’ innovations beyond the US.

ARS Pharmaceuticals has projected that neffy 1mg will be available to consumers in the US by the end of May 2025, offering a timely solution to pediatric allergic emergencies. This advancement is part of ARS Pharmaceuticals' broader strategic moves, which included a definitive merger agreement with Silverback Therapeutics in July 2022, executed through an all-stock transaction, underscoring the company’s commitment to expanding its reach and capabilities in the pharmaceutical market.

The introduction of neffy 1mg is poised to transform the landscape of allergy management, providing a safer, more accessible, and straightforward solution for one of the most vulnerable patient groups—pediatric patients. This aligns with ARS Pharmaceuticals’ mission to innovate and improve healthcare solutions for severe allergic reactions, promising significant benefits for children, caregivers, and healthcare providers alike.