neffy®, the first FDA approved emergency epinephrine nasal spray, is now available in a 1 mg dose, following its FDA approval in March 2025. This new dosage is specifically for children aged four years and older, weighing between 15 and less than 30 kilograms (approximately 33 to 66 pounds), for the treatment of Type I allergic reactions, including anaphylaxis. The introduction of this 1 mg option significantly extends protection to younger, school-aged children, who represent nearly 23% of those needing epinephrine, just in time for summer travel, camps, and the back-to-school season.
A major advantage of neffy is its needle-free administration, which helps overcome the common fear of needles in children (and adults) that can lead to critical delays in treatment during an allergic emergency. This design also eliminates the risk of accidental injections, an issue that occurs thousands of times annually with needle-based devices. Human factor studies have demonstrated high usability, with 100% of users successfully dosing neffy by following instructions, compared to error rates of up to 35% with some injection devices. Furthermore, neffy is compact, easy to carry, has a 24-month shelf life, and can withstand temperature exposures up to 122°F (50°C) for up to three months, even allowing for thawing if accidentally frozen without compromising quality.
ARS Pharma is committed to ensuring patient access and affordability for neffy. Through a co-pay savings program, eligible commercially insured patients can pay as little as $25 for two single-use devices. For uninsured or underinsured US residents who meet eligibility criteria, the ARS Pharma Patient Assistance Program will provide neffy at no cost. The company is actively working with major insurance providers such as United Healthcare, Express Scripts, and OptumRx to expand commercial coverage and simplify access, aiming to reduce restrictions and additional paperwork for physicians.
The expanded availability of neffy is praised by organizations like FARE (Food Allergy Research & Education), which highlights that a needle-free option may empower young children to report allergic reaction symptoms more promptly. This innovation supports the critical “Epi first, Epi fast” principle in managing anaphylaxis.
ARS Pharma also offers support through programs like neffyinSchools, which can receive the 1 mg dose, and provides resources on neffy.com, including savings programs and information for patients, caregivers, and healthcare professionals to navigate treatment and insurance.
