01:42 PM EDT, 08/09/2024 (MT Newswires) -- ARS Pharmaceuticals ( SPRY ) said Friday that the US Food and Drug Administration has approved neffy 2 mg, an epinephrine nasal spray, to treat Type I allergic reactions, including anaphylaxis, in adults and children weighing at least 30 kilograms.

In a statement, the FDA said neffy is the first approved epinephrine product for the emergency treatment of anaphylaxis that is not administered by injection.

The approval is based on four studies showing that epinephrine blood concentrations as well as increases in blood pressure and heart rate after neffy is given are comparable to those observed after administration of approved epinephrine injection products, according to the FDA.

A study of neffy in children also showed epinephrine concentrations were similar to those in adults, the regulator added.

Neffy is expected to be available in the US within eight weeks of its approval, ARS Pharmaceuticals ( SPRY ) said, adding that it also plans to submit a supplemental new drug application by the end of Q3 for a version of neffy to treat children weighing 15 kg to less than 30 kg.

Shares of ARS Pharmaceuticals ( SPRY ) were up 11.8% in recent Friday trading.

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