FDA Approves Neffy 1 mg Epinephrine Nasal Spray: Daily Dose

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Last week, we reported on the US FDA approval of neffy 1 mg (epinephrine nasal spray), marking the first and only needle-free epinephrine treatment indicated for pediatric patients weighing 15 to <30 kg.

The approval

Neffy is indicated for the emergency treatment of type I allergic reactions, including anaphylaxis, in adults and children aged 4 years and older who weigh ≥15 kg (33 lb). Each nasal spray contains a single dose of epinephrine and should be used immediately once an allergic reaction is recognized.

Clinical data presented by ARS Pharmaceuticals indicate that pharmacokinetic and pharmacodynamic responses to this nasal formulation are consistent with those produced by epinephrine injection products in both adult and pediatric populations. In pediatric trials, adverse events were generally mild and resolved without additional intervention. Human factor studies suggest children as young as 10 years of age can self-administer the drug when following instructions. Untrained individuals, such as teachers or babysitters, have also demonstrated the ability to administer the medication effectively.

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