The Food and Drug Administration has approved the neffy epinephrine spray to treat serious allergic reactions in children as young as 4 years old. The nasal spray is the first non-needle epinephrine treatment available in the U.S. for children weighing 30 to 66 pounds with food, drug and sting allergies.
“Many people wait to administer epinephrine until symptoms progress or take antihistamines as a first line of defense because they are afraid of injection,” says Dr. David Fleischer, director of allergy and immunology at Children’s Hospital Colorado. “Neffy’s small, user-friendly design addresses these challenges, empowering people to actually carry epinephrine and act quickly and confidently during an allergic emergency.”
The neffy sprayer – made by ARS Pharmaceuticals – contains a 1 milligram (mg) dose of epinephrine. Neffy 1 mg should become available in pharmacies by the end of May 2025.
Richard Lowenthal, ARS Pharma’s president and CEO, says the 1 mg neffy for smaller kids “offers families a long-awaited alternative” to epinephrine auto-injectors. About 1 in 13 U.S. children have food allergies.
“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,” Lowenthal says. “It will also eliminate risks like accidental needle injuries to children or caregivers.”
Neffy for Young Kids: Reducing Hesitation
The approval of the lower-dose sprayer comes seven months after the FDA approved a 2 mg neffy dose, making it the first needle-free alternative to auto-injectors. The higher dose is for adults and children weighing 66 pounds and up.
The food allergy community celebrated that approval. The addition of the neffy 1 mg dose extends the benefits of a needle-free option to more of the 5.6 million children in the U.S. with food allergy, according to the nonprofit FARE (Food Allergy Research & Education).
“The availability of neffy for younger children could help reduce hesitation and anxiety among parents, caregivers, and children, making it easier to administer treatment without delay when anaphylaxis is suspected,” says FARE’s CEO Sung Poblete, PhD, RN. “The principle of ‘epi first, epi fast’ is critical in reversing anaphylaxis, and we recognize neffy as an important resource for the food allergy community.”
Epinephrine is the only medication that can halt anaphylaxis. Yet studies show epinephrine is underused in severe allergic reactions.
Surveys show some parents often fail to recognize symptoms as severe or turn first to antihistamines. Some also report feeling nervous about using an auto-injector, and many people also don’t carry two auto-injectors at all times as recommended.
Research Behind Neffy’s Approval
Photo: ARS Pharma
The approval of neffy for younger kids was based on several studies involving both adult and pediatric patients as young as age 4. The studies compared peak epinephrine concentrations in the blood after using neffy versus an auto-injector or epinephrine from a syringe. The results showed peak concentrations were comparable among the various methods.
Studies also evaluated changes in blood pressure and heart rate, which are key indicators of epinephrine absorption. That research found similar increases among all epinephrine delivery methods.
ARS also did “human factor studies” showing that children as young as 10 years old can self-administer neffy. As well, “even untrained individuals, such as babysitters or teachers, can effectively administer neffy,” Lowenthal says.
To administer neffy for kids, simply place the sprayer into the nostril, and press. As with the 2 mg neffy, the sprayer should not be primed. There is also no need to hold it inside the nose after the epinephrine is released.
“The main consideration in an allergy emergency is to try and get the subject calm so you can quickly dose them. It takes just second or two,” Lowenthal says.
Adverse events in the pediatric trials were generally mild. Common side effects include nasal discomfort, headache, throat irritation, chest and nasal congestion, nervousness, nosebleed, dizziness, nausea, and vomiting.
The current FDA approval for the 1 mg dose goes down to age 4. However, Lowenthal says the FDA may later extend that to even younger children, as long as they weigh 30 pounds, as more data is collected.
Parents’ Interest, Plus Neffy for Toddlers?
Older children account for about two-thirds of neffy sales since the 2 mg sprayer became available. “Kids are the ones who dislike the auto-injectors more than anyone, so it makes sense they are the early adopters,” Lowenthal says.
He expects a similarly high level of enthusiasm among parents for the 1 mg dose. “We’ve been asked over and over from the day of approval [of the 2 mg dose] when we would have one for younger kids,” the CEO says.
ARS Pharma is also developing an even smaller dose for children under 30 pounds. The company is working with regulators at the FDA and in Europe to launch a study of the smaller dose in babies and toddlers.
One challenge is recruiting very young children to participate, Lowenthal says. So ARS Pharma is hoping that computer modeling on epinephrine absorption and action in the body can replace testing in toddlers. They are also working on modifying the sprayer to fit tiny noses.
“We’re not forgetting the little kids. We’re working on it,” Lowenthal says.
Neffy for Kids: Cost and Availability
Neffy 1 mg for young kids over age 4 is expected to be available in pharmacies in May. It will join the already available 2 mg sprayer for older children and adults.
Patients with insurance may pay as little as $25 for a two-pack of neffy sprayers by using this coupon. For those without insurance coverage, the cash price for a two-pack is $199 with a coupon.
Neffy can also be ordered at neffy.com. On the website, patients can upload a prescription for neffy sprayers and receive the medication in the mail from BlinkRx. Patients who need a prescription can also go to neffy.com to schedule an appointment with a telehealth provider for $35.
ARS Pharma also has a patient assistance program that provides neffy at no cost to qualifying individuals.
Neffy is now included on the prescription formularies for several national and regional commercial insurers. As of May 2025, 19 insurers, including United Healthcare, Express Scripts, Cigna Healthcare, OptumRx, Navitus Health Systems, and Tricare, cover neffy without prior authorization. Other commercial insurers require prior authorization, while some are still not covering neffy. A full list is here.
For insurance formularies that don’t yet include neffy, physicians can request prior authorization for patients. The ACAAI allergists’ organization has created this letter generator to assist. ARS Pharma will also facilitate this for patients who order the medication through neffy.com.
Shelf Life, School Access
Neffy’s has a 24-month shelf life at room temperature. (The 2 mg neffy has a slightly longer expiration date, 30 months).
The medication can withstand temperatures up to 122 degrees Fahrenheit for up to three months and still maintain much of its potency. If accidentally frozen, ARS says neffy can also be thawed without compromising the potency or the device.
ARS Pharma has also launched neffyinSchools, which offers free epinephrine sprayers to U.S. K-12 public and private schools for use in allergy emergencies. Both doses will be part of the school program, Lowenthal says.
However, some states require legislative or regulatory updated to permit stocking nasal epinephrine alongside stock epinephrine auto-injectors. Poblete says she hopes the neffy 1 mg dose could “help pave the way for increased access to unassigned epinephrine in daycare facilities and school classrooms across the U.S.”
Plans for the UK, Canada and Europe
ARS Pharma has filed for approval of its 2 mg sprayer in Canada and the United Kingdom. In those countries, it will be called EURneffy and sold by the pharmaceutical company ALK-Abelló.
Approval is expected in the U.K. this summer and in Canada by late 2025, Lowenthal says.
In August 2024, the European Commission approved the 2-mg EURneffy for the emergency treatment of allergic reactions in the European Union. Approval of the 1 mg dose is anticipated by the end of 2025.
Related Reading:
Neffy Epi Sprayers Now Available in U.S. Pharmacies and Online
Schools and Locked Up Epinephrine: A Dangerous Situation
