FDA Approves neffy (epinephrine nasal spray) Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis
FDA approves neffy (epinephrine nasal spray) 2 mg for Type I Allergic Reactions, including anaphylaxis, in adults and children ≥30 kg, marking the first needle-free epinephrine treatment innovation in over 35 years.
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FDA approves neffy, the first epinephrine nasal spray for treating anaphylaxis in adults and children over 30 kg. Studies show comparable blood epinephrine levels to injections. Administered via a single nostril spray, with a second dose if needed. Common side effects include throat irritation, nasal tingling, and headaches. Addresses fear of injections in some patients.
ARS Pharmaceuticals submits sNDA for neffy 1 mg, a needle-free epinephrine treatment for children 15-30 kg, following FDA approval of neffy 2 mg in 2024.
ARS Pharmaceuticals submitted an FDA application for neffy 1 mg to treat type 1 allergic reactions in children weighing 33-66 lb, following approval for adults in August. The nasal spray aims to eliminate needle fear and accidental injuries, with studies showing children as young as 10 can self-administer. ARS is also developing nasal sprays for other type 1 hypersensitivity reactions, including urticaria.
FDA approves neffy (epinephrine nasal spray) 2 mg for Type I Allergic Reactions, including anaphylaxis, in adults and children ≥30 kg, marking the first needle-free epinephrine treatment innovation in over 35 years.
ARS Pharmaceuticals submits sNDA to FDA for neffy 1 mg nasal spray for treating type 1 allergic reactions in children 15-30 kg, aiming to address needle phobia and improve emergency treatment access.
ARS Pharmaceuticals submits sNDA for neffy 1 mg, a needle-free epinephrine treatment for children 15-30 kg, aiming to address needle fear and improve emergency treatment for Type I Allergic Reactions, including anaphylaxis.
ARS Pharmaceuticals announces the U.S. availability of neffy® (epinephrine nasal spray) for treating Type I Allergic Reactions, including anaphylaxis, in adults and children weighing ≥30 kg. neffy is accessible through various programs, including a $25 co-pay for insured patients and a $199 cash price for uninsured patients. ARS also plans to expand access to EURneffy® in the EU by Q4 2024 and has submitted an FDA application for pediatric use.
FDA approves neffy, a needle-free nasal spray epinephrine for treating anaphylaxis in adults and children over 66 lbs, addressing fears of needles and auto-injector use. Expected to be available in late October, priced at $199 for a two-pack, with insurance co-pays at $25. ARS plans to seek FDA approval for children 30-66 lbs later this year.