The FDA has approved neffy 1 mg (epinephrine nasal spray) for the treatment of type I allergic reactions, including anaphylaxis, in pediatric patients aged 4 years and older who weigh 15 kg to less than 30 kg.

ARS Pharmaceuticals, Inc. announced the approval, marking the first needle-free epinephrine option for this population. The intranasal formulation is intended to address barriers associated with traditional autoinjectors, such as fear of needles and treatment delays.

Severe allergic reactions are common among children: An estimated one in 13 are affected, and more than 40% experience severe episodes. Despite evidence supporting early epinephrine administration, approximately 40% of patients delay treatment, and 56% of caregivers report hesitancy in using autoinjectors. However, neffy delivers epinephrine via nasal spray without requiring nasal hold time, which facilitates rapid administration. Human factor studies indicated that children as young as 10 years old, as well as untrained caregivers, can effectively administer the medication.

FDA approval was based on clinical trial data demonstrating that neffy achieved pharmacokinetic and pharmacodynamic responses that were comparable to epinephrine injection products. Pediatric trials reported adverse events that were typically short-lived and mild. Stability studies indicated a 24-month shelf life at room temperature and resistance to temperature extremes up to 122°F for 3 months. The product can be thawed and used after accidental freezing without compromising efficacy.

ARS Pharmaceuticals anticipates commercial availability of neffy 1 mg in the U.S. by May 2025. The company has launched neffyConnect, a support program that assists patients and providers with access, insurance navigation, and financial assistance. Eligible patients with commercial insurance may obtain two single-use devices for a maximum out-of-pocket cost of $25, and additional affordability programs are available for uninsured patients. The neffyinSchools initiative will provide access to neffy for eligible educational institutions.

This approval follows the August 2024 FDA approval of neffy 2 mg for pediatric patients who weighed at least 30 kg, as well as its authorization in the European Union as EURneffy. The availability of a needle-free epinephrine formulation may mitigate barriers to timely administration and improve adherence in patients who are at risk for anaphylaxis.