ARS Pharmaceuticals submits sNDA to FDA for neffy 1 mg

ARS Pharmaceuticals announced the submission of a supplemental New Drug Application for neffy 1 mg for the treatment of Type I Allergic Reactions, including anaphylaxis, in children who weigh 15 to 30 kg. Pharmacokinetic data for neffy 1mg were slightly higher than that of adults who receive the same dose and pharmacodynamic response was similar. Food allergies affect approximately six million children in the U.S., of which more than 40 percent have experienced a severe allergic reaction such as anaphylaxis. Additionally, studies show that two out of three children are afraid of needles and more than half of parents express fear about using their child’s epinephrine auto-injector – a potentially lifesaving treatment. “Fear of needles is a common reason children refuse treatment with auto-injectors. If approved, neffy 1mg will be the first needle-free epinephrine option for younger children, in addition to being the first new delivery method for this population in more than 35 years,” says Richard Lowenthal, Co-Founder, President and CEO of ARS Pharmaceuticals. “Nearly half of all current epinephrine auto-injector prescriptions are for children, and more than half of those are for children weighing 15 to 30 kg (33-66 lbs.). We believe there is a clear need for innovative treatments like neffy 1mg.”