On Wednesday, the FDA approved ARS Pharmaceuticals, Inc.’s (NASDAQ:SPRY) neffy 1 mg (epinephrine nasal spray) for Type I Allergic Reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to < 30 kilograms.
The approval represents the first significant innovation in the delivery of epinephrine for this patient population in more than 35 years.
Approval of neffy 1 mg follows FDA approval for neffy 2 mg for children and adults weighing 30kg and for EURneffy in the EU by the European Commission in August 2024.
The approval of neffy 1 mg is based on data from clinical trials, including pharmacokinetic (PK) and pharmacodynamic (PD) responses in pediatric and adult subjects consistent with those of epinephrine injection products.
Adverse events in pediatric trials were generally mild and transient.
The …
