FDA Approves Neffy® 1mg Epinephrine Nasal Spray for Children Weighing 33 to 66 Pounds

For parents of children with severe food allergies, the wait for a needle-free epinephrine option is finally over. The FDA has officially approved neffy® 1mg epinephrine nasal spray for kids weighing 33 to 66 pounds (15 to <30 kg). This groundbreaking approval introduces the first-ever needle-free epinephrine treatment specifically designed for younger children, offering a safe, effective, and easy-to-use alternative to traditional auto-injectors.

Why This Approval Matters for Families with Food Allergies

Food allergies are a growing concern, affecting approximately one in 13 children in the U.S., with over 40% experiencing severe reactions. While epinephrine is the first-line treatment for anaphylaxis, studies show that many caregivers hesitate to use traditional needle-based auto-injectors due to fear of administering the injection. The approval of neffy® 1mg eliminates this fear by offering a simple nasal spray that delivers epinephrine instantly, without the need for a needle.

Benefits of neffy® 1mg Epinephrine Nasal Spray

• Needle-Free Administration: No injections, making it easier for caregivers and children to use.

• Fast & Effective: Delivers a precise dose of epinephrine instantly without nasal hold time.

• Kid-Friendly Design: A small, easy-to-carry device that helps reduce treatment hesitation.

• Proven Safety & Effectiveness: Backed by clinical trials demonstrating consistent performance with traditional auto-injectors.

• Long Shelf Life & Stability: Stays effective for 24 months at room temperature and remains stable in high temperatures up to 122°F (50°C).

Addressing the Fear of Epinephrine Auto-Injectors

A significant barrier to timely epinephrine use is needle anxiety. Research shows that 56% of caregivers fear using needle-based injectors on their children, leading to delayed or missed treatments. The neffy® nasal spray offers a needle-free alternative, increasing the likelihood that caregivers will administer epinephrine promptly during an allergic emergency.

According to Dr. David Fleischer, Section Head of Allergy & Immunology at Children’s Hospital Colorado, the availability of neffy® represents a major breakthrough in allergy treatment. He highlights that many people wait too long to administer epinephrine due to fear, but with neffy®, caregivers can act quickly and confidently to prevent severe allergic reactions from escalating.

Who Can Use neffy® 1mg?

The FDA has approved neffy® 1mg for children aged 4 years and older who weigh between 33 and 66 pounds. This approval follows the previous FDA approval of neffy® 2mg in August 2024, which is designed for children and adults weighing 66 pounds or more.

When and Where Will neffy® Be Available?

The nasal spray is expected to be available in the U.S. by the end of May 2025. Families can access financial support through the neffyConnect program, which helps with medication fulfillment, insurance navigation, and co-pay savings.

• Co-Pay Savings: Most insured patients will pay no more than $25 for two doses.

• Cash Price: If insurance does not cover neffy®, a two-dose pack will be available for $199.

• School Availability: Schools participating in the neffy in Schools program will receive doses upon availability.

For more details, visit neffy.com.

What This Means for the Food Allergy Community

The approval of neffy® 1mg is a game-changer for children with severe food allergies and their families. With an easy-to-use, needle-free alternative now available, parents and caregivers no longer have to hesitate when responding to allergic reactions. This innovation ensures faster treatment, greater accessibility, and improved quality of life for those living with life-threatening allergies.

At No Nuts!, we are dedicated to spreading awareness about food allergy safety and supporting families with delicious, allergen-free snacks. Stay informed about the latest allergy-friendly innovations by following our blog and exploring our range of safe, nut-free snacks at GoNoNuts.com!