US-based biotechnology company ARS Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for neffy 1mg, an epinephrine nasal spray.
The nasal spray is indicated for the treatment of Type 1 allergic reactions in children aged four years and older, weighing 15 to less than 30kg.
Neffy provides a needle-free epinephrine delivery method through a nasal spray and is the first major advancement in epinephrine delivery for children in over 35 years.
The current approval follows the FDA approval of neffy 2mg in August last year, and the European Commission (EC) approval in August last year.
ARS Pharma co-founder, president, and CEO Richard Lowenthal said: “Today’s FDA approval of neffy 1 mg marks a major milestone towards our efforts to transform the management of severe allergic reactions.
“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 30kgs, 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.”
The FDA approval of neffy 1mg was based on comprehensive clinical trials, including pharmacokinetic and pharmacodynamic studies in both paediatric and adult subjects.
The studies showed comparable results to traditional epinephrine injection products, with mild and transient adverse events reported.
According to human factor studies, children as young as ten could effectively use the device, and untrained individuals like babysitters or teachers could administer it successfully.
Neffy has a shelf-life of 24 months at room temperature and can withstand temperatures up to 50°C for up to three months.
If accidentally frozen, it can be thawed without affecting its quality or reliability.
ARS Pharmaceuticals plans to commercialise neffy 1mg in the US by the end of May 2025, with a focus on accessibility and affordability.
Furthermore, the company is launching the neffyConnect programme, to support patients, caregivers, and healthcare professionals, with financial assistance.
Children’s Hospital Colorado allergy and immunology section head and paediatrics professor David Fleischer said: “The availability of a needle-free epinephrine option for children is a breakthrough in the treatment of severe allergic reactions.
“Many people wait to administer epinephrine until symptoms progress or take antihistamines as a first line of defence because they are afraid of injection.
“Neffy’s small, user-friendly design addresses these challenges, empowering people to actually carry epinephrine and act quickly and confidently during an allergic emergency.”
