ARS Pharma Submits SNDA For Neffy 1 Mg Dose For Pediatric Type I Allergic Reactions

(RTTNews) - ARS Pharmaceuticals Inc. (SPRY) announced the submission of a supplemental New Drug Application (sNDA) for neffy 1 mg for the treatment of Type I Allergic Reactions, including anaphylaxis, in children who weigh 15 to 30 kg. Pharmacokinetic (PK) data for neffy 1mg were slightly higher than that of adults who receive the same dose and pharmacodynamic (PD) response was similar.

The submission of the neffy 1 mg sNDA follows the FDA approval of neffy (2 mg) on August 9, 2024, for treating Type I Allergic Reactions, including anaphylaxis, in adults and children weighing 30 kg (66 lbs.) or more.

If approved, neffy 1 mg will be the first and only needle-free epinephrine treatment available for younger school-aged children, the company said.

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