ARS Pharma wins new FDA approval for neffy

ARS Pharmaceuticals’ (Nasdaq: SPRY) shares closed up 3.4% at $10.87 yesterday, after the company announced that the US Food and Drug Administration (FDA) had approved neffy 1mg (epinephrine nasal spray) for a new indication.

Neffy 1mg is now authorized for the treatment of Type I Allergic Reactions, including anaphylaxis, in children who are aged four years and older and weigh 15 to < 30 kilograms (33 to < 66 lb.). This approval represents the first significant innovation in the delivery of epinephrine for this patient population in more than 35 years, the company noted.

“The availability of a needle-free epinephrine option for children is a breakthrough in the treatment of severe allergic reactions,” says Dr David Fleischer, Section Head of Allergy & Immunology, and Professor of Pediatrics, at Children’s Hospital Colorado.