The U.S. Food and Drug Administration has lifted the age restriction on the 1-milligram neffy epinephrine spray or kids. Initially, the agency approved the device according to weight and age – children had to be at least 4 years old for a prescription.
In updating the labeling criteria for the neffy 1 mg, the FDA now says the epinephrine spray can be prescribed for children at risk of allergic reactions on the basis of weight alone. Qualifying children need to weigh between 33 and 66 pounds (15 to 30 kilograms).
This opens the door to the popular needle-free epinephrine device for many families with younger children in this weight range.
ARS Pharmaceuticals, neffy’s manufacturer, welcomed the FDA’s prescription label update. “This is a major advancement for the families with small children who live with the constant worry of severe allergic reactions in their youngest children,” said Richard Lowenthal, ARS Pharma’s president and CEO.
The company has heard considerable demand for neffy from parents of children under age 4. Lowenthal explains that about one-quarter of patients requiring epinephrine are in the 33- to 66-pound weight range. He says this includes 25 percent under the age of 4.
“We’ve had a lot of people contact us to say, ‘I’m waiting for my child to turn 4, so I can get neffy,'” Lowenthal told Allergic Living. “So this makes it available to the smaller kids within that weight class.”
Epinephrine is the only medication that can halt anaphylaxis. Yet, Lowenthal notes that caregivers can be fearful of administering a needle-based auto-injector to a young child. So the FDA’s widened approval “is a big benefit.”
In a statement, Lowenthal also said neffy’s ease of use will help families with young kids to “act quickly with confidence during emergencies.”
Neffy Label: Temperature Advice
ARS Pharma got the FDA to consider the weight-only label change by submitting data from clinical trials. The data showed the use of neffy 1 mg in children as young as 2 years old.
For children and adults weighing over 66 pounds, the FDA first approved the neffy 2 mg back in the summer of 2024.
For both dosages, the FDA also updated language to explain that even if a patient “sniffs in” after administering the neffy spray, an additional sprayer is not needed if symptoms are improving.
There’s also a label revision for the device in relation to temperature. The label now will read that a temperature exposure of up to 122 degrees F is allowed. As well, if the device is accidentally frozen, the FDA says it can be used after thawing.
Neffy for Infants: in the Works
ARS Pharma is starting work to develop a 0.1 mg dose neffy spray for infants and toddlers 16.5 to 33 pounds. (Currently, only AUVI-Q has an epinephrine device in that dosage for little kids.)
Lowenthal tells Allergic Living that a research team is enrolling infants and toddlers to begin a pharmacokinetic (or PK) study. For such young children, ARS Pharma’s team has modified the tip of the epinephrine sprayer. “It can just be put up against the nose, and it has a little nipple that sprays up into the nose,” explains the CEO.
He hopes the researchers can wrap up the study by the end of the year. ARS Pharma would then submit the data in 0.1 mg device to the FDA for a six-month review process.
Related Reading:
Neffy Epinephrine Spray Rapidly Reversed Anaphylaxis in Children
Anaphylaxis But No Epinephrine: Inside an Epidemic of Hesitation
