ARS PHARMACEUTICALS

Food allergies affect 8% of US children, with severe reactions requiring immediate treatment. Epinephrine is key for anaphylaxis, traditionally via auto-injectors. A new FDA-approved epinephrine nasal spray offers a needle-free option, addressing trypanophobia and administration hesitancy, though efficacy and accessibility concerns remain.

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2024 saw FDA approvals for needle-free pediatric treatments: epinephrine nasal spray (neffy) for anaphylaxis and FluMist for influenza, addressing needle phobia and improving vaccine administration.

neffy, the first FDA-approved epinephrine nasal spray for Type I Allergic Reactions, was added to Express Scripts' Commercial formularies on November 22, 2024, enhancing access for patients and caregivers. This needle-free alternative offers a user-friendly, portable solution for emergency treatment, with a 30-month shelf life and temperature tolerance up to 122°F.

ARS Pharmaceuticals announced Express Scripts added neffy to its Commercial national formularies, making it widely available. neffy 2 mg, the first FDA-approved epinephrine nasal spray, offers a needle-free alternative for treating Type I Allergic Reactions, including anaphylaxis, with a 30-month shelf-life and temperature tolerance up to 122°F.

2024 saw over 25 pediatric FDA approvals, including givinostat for Duchenne muscular dystrophy, FluMist for influenza, clonidine hydrochloride for ADHD, dupilumab for eosinophilic esophagitis, epinephrine nasal spray for anaphylaxis, and roflumilast cream for atopic dermatitis.

ARS Pharmaceuticals announced its licensing partners in China, Japan, and Australia filed for approval of neffy® (epinephrine nasal spray) 2 mg. neffy 2 mg was recently approved in the U.S. for treating Type I Allergic Reactions, including anaphylaxis, in adults and children weighing ≥30 kg. ARS Pharma conducted a Phase 3 study in Japanese pediatric patients showing 100% response to neffy, with a median resolution time of 16 minutes. The company retains U.S. rights and has licensing partnerships in China, Japan, Australia, and New Zealand.

ARS Pharmaceuticals to launch neffyinSchools Program in Jan 2025, providing free neffy® (epinephrine nasal spray) 2mg to eligible U.S. K-12 schools for emergency anaphylaxis treatment in adults and children ≥30 kg.