FDA approves epinephrine nasal spray for children aged as young as 4 years
Key takeaways:
- Fear of needles may delay treatment with injectable epinephrine.
- Children as young as age 10 years can be taught how to use neffy.
- Payment options are available based on insurance coverage.
The FDA has approved neffy 1 mg epinephrine nasal spray for treating anaphylaxis and other type 1 allergic reactions in children aged 4 years and older, according to a press release from ARS Pharma.
This new dosage also specifies children must weigh between 15 kg and less than 30 kg, or 33 lb and less than 66 lb.
This approval was based on data indicating pharmacokinetic and pharmacodynamic responses in pediatric and adult subjects that were consistent with responses to injectable epinephrine, according to the press release. Pediatric subjects had generally mild and transient adverse events.
“Many children and caregivers fear needle-based autoinjectors, which can delay lifesaving treatment,” Richard Lowenthal, MS, MSEL (MBA), cofounder, president and CEO of ARS Pharma, said in the press release.
Lowenthal noted that nearly four out of 10 prescriptions for epinephrine in the United States are for children, with nearly one-third of those written for children between 15 kg and 30 kg.
“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,” he said. “It will also eliminate risks like accidental needle injuries to children or caregivers.”
Human factor studies have indicated that children aged as young as 10 years can follow instructions to use neffy effectively, ARS Pharma said. Babysitters, teachers, and other untrained individuals can administer it effectively as well, the company continued.
At room temperature, ARS Pharma said, neffy has a shelf life of 24 months. It also can tolerate up to 50°C (122°F) for up to 3 months and can be thawed after it has been frozen with no impact on quality or reliability, the company continued.
ARS Pharma expects neffy 1 mg to be available in the United States by the end of May 2025, with most commercially insured patients paying $25 for a pair of single-use devices. When insurance does not cover neffy 1 mg, patients can get a pair of doses for $199 through BlinkRx.
The ARS Pharma Patient Assistance Program also will provide neffy 1 mg at no cost to qualified patients. The neffyinSchools program will provide free neffy 1 mg to eligible schools for stock administration as well.