ARS Pharmaceuticals, Inc. announced that positive clinical data supporting neffy® (previously referred to as ARS-1), the potential first non-injectable medicine for treatment of allergic reactions (Type I), including anaphylaxis, will be presented during the 2022 American College of Allergy Asthma and Immunology Annual Scientific Meeting (ACAAI). The meeting is being held November 10-14, 2022, in Louisville, Kentucky. Presentations will highlight findings from multiple clinical trials of neffy (EPI-15 and EPI-16) that were included in the company's New Drug Application (NDA) for neffy as an emergency treatment of allergic reactions (Type I) including anaphylaxis in adults and children =30 kg (66 lbs).

The U.S. Food and Drug Administration (FDA) has accepted the NDA for neffy for review with a Prescription Drug User Fee Act (PDUFA) target action date anticipated in mid-2023. Data from the EPI-15 and EPI-16 clinical trials demonstrated that neffy delivered consistent epinephrine levels to attain pharmacokinetic (PK) profile in range of approved intra-muscular (IM) injection products' PK under normal and rhinitis conditions. Additionally, neffy's Pharmacodynamic (PD) profile, the surrogate measure for assessing clinical effectiveness in anaphylaxis (for example, increased blood pressure, heart rate), demonstrated comparable or greater PD response compared with currently approved IM injectable products.

These data also provide important insights into the mechanism of action of intranasal epinephrine. ARS will also present findings from a physician/caregiver survey, which suggests that patients and caregivers have a preference for a needle-free epinephrine alternative and would dose neffy sooner in the course of an allergic reaction without the hesitation caused by fear of the needle and pain.