The U.S. Food and Drug Administration (FDA) has approved ARS Pharmaceuticals’ neffy 1 mg (epinephrine nasal spray) for the treatment of Type I Allergic Reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to < 30 kilograms. This approval represents the first significant innovation in the delivery of epinephrine for this patient population in more than 35 years.
In the general population, approximately one in 13 children have severe food allergies, and more than 40 percent have experienced severe reactions. Despite the clear link between early epinephrine use and better outcomes, research shows that approximately 40 percent of patients delay treatment, and 56 percent of caregivers fear using needle-based auto-injectors on their child. neffy eliminates needles, delivering a precise epinephrine dose via a simple nasal spray, almost instantly, with no nasal hold time required.
“Today’s FDA approval of neffy 1 mg marks a major milestone towards our efforts to transform the management of severe allergic reactions,” says Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. “Many children and caregivers fear needle-based auto-injectors, which can delay lifesaving treatment. neffy’s needle-free, easy-to-use design addresses this unmet need, offering families a long-awaited alternative.
“With nearly four out of 10 U.S. epinephrine prescriptions written for children under the age of 18—and nearly a third of those for children weighing 15 to 30 kilograms—we believe neffy 1 mg will improve access to a needle-free option for the treatment of severe allergies and reduce hesitation in treating this vulnerable group. It will also eliminate risks like accidental needle injuries to children or caregivers.”
The approval of neffy 1 mg is based on data from extensive clinical trials, including pharmacokinetic (PK) and pharmacodynamic (PD) responses in pediatric and adult subjects that were consistent with those of epinephrine injection products. Adverse events in pediatric trials were generally mild and transient.
Human factor studies also show children as young as 10 can use neffy effectively by following instructions, and that even untrained individuals, such as babysitters or teachers, can effectively administer neffy.
