ARS Pharmaceuticals has been granted approval by the US Food and Drug Administration (FDA) for their epinephrine nasal spray, neffy, to be used as treatment of type 1 allergic reactions including anaphylaxis.

This is the first needle-free delivery option available for patients at this time. The spray is approved for paediatric patients in addition to adult patients who weigh under 30kg, and has received fast track designation.

The approval of neffy is based on data from five primary registration studies with a 2mg intranasal dose of epinephrine. These primary clinical trials were supported by numerous supportive and pilot studies. neffy met all defined clinical endpoints and its pharmacodynamic and pharmacokinetic data were within the range of approved epinephrine injection products.

Richard Lowenthal, co-founder, president and chief executive officer, ARS Pharmaceuticals, said: “This approval marks a watershed moment in addressing an unmet medical need for people with type 1 allergies – a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many,”.

“Epinephrine treatment is only effective if available, readily usable, and administered appropriately. Our team has worked tirelessly to create an easy-to-carry, easy-to-use, needle-free device that offers peace of mind to patients and caregivers by enabling them to administer epinephrine quickly and confidently when needed” added Richard Lowenthal.

No serious adverse events were reported in any clinical study. Adverse events in neffy clinical trials were generally mild in nature without any meaningful nasal irritation or pain.

Type 1 allergic reactions, including those caused by food, medications and insect bites, can lead to life-threatening anaphylaxis and result in an estimated 500,000 emergency room (ER) visits each year, with nearly 60% of such patients reported to not have received epinephrine prior to visiting the ER.