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ARS Pharmaceuticals Receives FDA Approval of neffy® (epinephrine nasal spray), the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis
neffy Offers Adults and Children (≥30 kg) Living with Severe Allergic Reactions the First New Delivery Method for Epinephrine in more than 35 Years
About this update from Ars Pharmaceuticals, Inc.
[{"type":"text","content":"neffy Offers Adults and Children (≥30 kg) Living with Severe Allergic Reactions the First New Delivery Method for Epinephrine in more than 35 Years Well-capitalized to Support Launch and Commercialization of neffy in the U.S., and an Expected Operating Runway of at Least Three Years ARS Pharma to Host Investor Conference Call on Monday, August 12, 2024, at 8:00 am ET SAN DIEGO, Aug. 09, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today announced that the U.S. Food and Drug Administration (FDA) approved neffy® (epinephrine nasal spray) 2 mg for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.). The approval represents the first significant innovation in the delivery of epinephrine in more than 35 years and is the first and only needle-free treatment option for patients and families living with severe allergic reactions. “Until today, patients with severe allergic reactions, including anaphylaxis, only had one treatment option – an often painful and anxiety-inducing needle injection of epinephrine. In some cases, patients would delay or not administer the life-saving treatment at the onset of symptoms, increasing the risk for a severe reaction or negative outcomes requiring additional emergency medical treatment,” said Thomas B. Casale, M.D., Professor of Medicine and Pediatrics and Chief of Clinical and Translational Research in the USF Health Morsani College of Medicine's Division of Allergy and Immunology at the University of South Florida in Tampa, Florida. “FDA approval of neffy means that patients with severe allergies finally gain a long-awaited, needle-free, easy-to-carry epinephrine delivery method that has the potential to reduce time to administration, which can lead to better clinical outcomes and improvements in quality of life for patients and their caregivers.” Type I allergic reactions, including those caused by food, medications, and insect bites, can lead to life-threatening anaphylaxis and result in an estimated 500,000 emergency room (ER) visits each year, with nearly 60% of such patients reported to not have received epinephrine prior to visiting the ...