ARS Pharmaceuticals Receives FDA Approval to Remove Age Requirement From neffy® 1 mg (epinephrine nasal spray) Label

Core Viewpoint - The FDA has approved an update to the prescribing information for neffy® 1 mg, allowing all children and adults weighing 33 lbs. or more to use the needle-free epinephrine nasal spray for emergency treatment of Type 1 allergic reactions, including anaphylaxis, without age restrictions [1][2] Group 1: Product Information - neffy is indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in patients who weigh 33 lbs. or greater [5][14] - neffy is available in two doses: 1 mg for patients weighing ≥33 lbs. and <66 lbs. and 2 mg for those weighing 66 lbs. or more [3][4] - The updated labeling recommends that neffy be stored in blister packaging or a carrying case, which will be included with each prescription starting this summer [1][2] Group 2: Market Impact - Approximately 25% of patients requiring epinephrine are children weighing ≥33 lbs. and <66 lbs., with a significant portion being under four years old [2] - The update is expected to alleviate fears among caregivers regarding needle-based treatments, thereby increasing access to emergency treatment for young patients [2][13] - There are approximately 40 million people in the U.S. experiencing Type I allergic reactions, with 20 million diagnosed and treated for severe reactions over the last three years [13] Group 3: Clinical Insights - The FDA's label update includes more flexible guidance regarding the use of neffy, such as management of symptoms if a patient sniffs after dosing and the allowance for use after accidental freezing [2] - The availability of a needle-free option is seen as a significant advancement in broadening access and lowering treatment hurdles for caregivers [2][13]