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ARS Pharma’s epinephrine nasal spray 1mg now available in US

The spray has a shelf life of two years and can withstand temperature exposures up to 122°F (50°C).

gullapalli May 08 2025

ARS Pharmaceuticals has announced the availability of neffy (epinephrine nasal spray) 1mg in the US, providing a new option for treating Type I allergic reactions, including anaphylaxis, in children weighing between 15 and 30kg.

Approved by the US Food and Drug Administration (FDA) in March 2025, the spray is now accessible on prescription in a compact and user-friendly format intended as a convenient addition to a lunchbox or backpack.

Human factor studies have demonstrated that users could take neffy by following the instructions. 35% error rates have been observed with injectable epinephrine devices.

The spray has a shelf life of two years and can withstand temperature exposures up to 122°F (50°C) for up to three months.

Even if frozen unintentionally, the product's reliability and quality remain unaffected after thawing.

ARS Pharmaceuticals chief commercial officer Eric Karas stated: “The availability of the 1mg dose before summer travel, camps and back-to-school season will help communities better prepare for allergic emergencies.

“The needle-free design of neffy also eliminates the risk of adverse events, such as accidental injections into the hands or fingers of a child or caregiver, which happens about 3,500 times each year. Now is a great time for parents to reach out to their healthcare providers to ask for neffy as a treatment for their young children.”

In the European Union (EU), where the spray is marketed as EURneffy, it is indicated for emergency treatment of allergic reactions due to allergens, and for idiopathic or exercise-induced anaphylaxis in adult and paediatric patients weighing 30 kgs or more.

Type I allergic reactions can be life-threatening, necessitating immediate intervention with epinephrine, which is the sole medication approved by the US regulator for such emergencies.

In 2024, ALK-Abelló acquired the rights to neffy adrenaline nasal spray in Europe and Canada, amongst other regions, from ARS for an upfront payment of $145m.

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