ARS PHARMACEUTICALS

ARS Pharmaceuticals introduces Neffy, a needle-free epinephrine nasal spray for treating severe allergic reactions, approved by the FDA. Aimed at reducing fear and hesitation associated with EpiPen injections, Neffy offers a simpler, quicker administration method, potentially improving treatment accessibility for millions.

Renaissance Lakewood, LLC, a global CDMO, manufactures neffy, the first FDA-approved needle-free epinephrine nasal spray for Type I allergic reactions, including anaphylaxis. The six-year partnership with ARS Pharmaceuticals involved all stages of development and manufacturing. Renaissance's recent campus expansion and additional packaging lines ensure capacity to meet global market demands.

Renaissance Lakewood, LLC, a global CDMO, manufactures neffy, the first FDA-approved needle-free, intranasal epinephrine spray for Type I allergic reactions, including anaphylaxis in adults and children. The six-year partnership with ARS Pharmaceuticals involved every stage of development and commercialization, ensuring a scalable and robust manufacturing process. Renaissance's recent campus expansion and additional packaging lines support global market demands for neffy.

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.

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.

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, following FDA approval of neffy 2 mg in 2024.

Pre-ordering for epinephrine nasal spray (neffy) has launched for treating allergic reactions, including anaphylaxis. The FDA approved trofinetide (Daybue) for Rett syndrome, marking a milestone in treatment. A study in JAMA Pediatrics found not all screen time before bed negatively impacts sleep in children. Another study in The American Journal of Clinical Nutrition linked fish intake during pregnancy to reduced autism risk in children.

The FDA approved ARS Pharmaceuticals' needle-free epinephrine nasal spray, marking a significant advancement in treating severe allergic reactions. This innovation offers an alternative to autoinjectors like EpiPen, addressing injection fears. Priced at $199 for two doses, with a co-pay savings program, it aims to improve treatment accessibility and outcomes.