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ARS Pharmaceuticals Announces Presentation of Data Supporting neffy (epinephrine nasal spray) and Real-World Burden of Needle Injectors
Data to be Presented in Five Poster Presentations at the 2023 American Academy of Allergy, Asthma and Immunology Annual Meeting Data Support New Drug
About this update from Ars Pharmaceuticals, Inc.
[{"type":"text","content":"Data to be Presented in Five Poster Presentations at the 2023 American Academy of Allergy, Asthma and Immunology Annual Meeting Data Support New Drug Application for neffy®, Currently Under Review with the FDA SAN DIEGO, Feb. 23, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced that positive 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 2023 American Academy of Allergy, Asthma and Immunology (AAAAI) meeting. The meeting is being held February 24-27, 2023, in San Antonio, Texas. Presentations will highlight findings from self-administration and pediatric clinical trials of neffy as well as an integrated analysis of more than 600 subjects, 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). Data from the clinical trials demonstrated that neffy delivered consistent epinephrine levels to attain a pharmacokinetic (PK) and pharmacodynamic (PD) profile within the range of approved intramuscular (IM) injection products with a dose proportional exposure between once and twice dosing. ARS will also present findings from surveys of 300 patients identifying that the needle is the principal reason why patients do not fill their epinephrine prescription today, and why they delay epinephrine use and use OTC products first despite treatment guidelines recommending immediate use of epinephrine. “We are excited to share these data from two of our primary clinical trials and the integrated analysis demonstrating the performance of neffy. The research demonstrates that neffy delivers consistent epinephrine levels across a range of administration conditions, including during self-administration and in children,” said Richard Lowenthal, M.Sc., MSEL, co-founder and chief executive officer of ARS. “Severe allergic reactions can quickly progress and be life-threatening, and our real-world surveys of standard of care identify that people’s fear of injecting e...