FDA Approves 1 mg neffy Nasal Spray for Pediatric Anaphylaxis

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Key Takeaways

FDA approved 1 mg epinephrine nasal spray for children aged 4+ weighing 15-30 kg, enhancing treatment options for severe allergies.
The needle-free design of the nasal spray addresses injection fears, potentially improving adherence and outcomes in allergic emergencies.
Clinical studies show the nasal spray's pharmacokinetic and pharmacodynamic responses are consistent with injection products.
ARS Pharmaceuticals offers programs to improve accessibility, including financial support and patient assistance for eligible individuals.

The FDA approval for epinephrine nasal spray 1 mg is indicated for type 1 allergic reactions in children 15 to 30 kg and 4 years or older.

Credit: US Food and Drug Administration

ARS Pharmaceuticals has announced the US Food and Drug Administration (FDA) approval of epinephrine nasal spray 1 mg (neffy) for the treatment of type 1 allergic reactions, including anaphylaxis, in patients aged 4 years and older weighing 15 to less than 30 kg.¹

Announced on March 05, 2025, the approval comes less than 7 months after the company announced the historic FDA approval of epinephrine nasal spray 2 mg (neffy) in adults and children in adults and children who weigh 30 kg or more. According to the March 2025 release from ARS Pharmaceuticals, availability of the new 1 mg formulation is expected by May 2025.^1,2

“The availability of a needle-free epinephrine option for children is a breakthrough in the treatment of severe allergic reactions,” said David Fleischer, MD, section head of Allergy & Immunology and professor of Pediatrics at Children’s Hospital Colorado.¹ “Many people wait to administer epinephrine until symptoms progress or take antihistamines as a first line of defense because they are afraid of injection. [Epinephrine nasal spray] small, user-friendly design addresses these challenges, empowering people to actually carry epinephrine and act quickly and confidently during an allergic emergency. This innovation will likely significantly improve health outcomes and enhance quality of life.”

According to ARS Pharmaceuticals, the approval of epinephrine nasal spray 1 mg is based on multiple clinical studies, including pharmacokinetic and pharmacodynamic responses in pediatric and adult subjects that were consistent with those of epinephrine injection products. In the same release, ARS Pharmaceuticals called attention to human factor studies demonstrating children as young as 10 years old are able to epinephrine nasal spray effectively by following instructions and untrained caregivers, such as babysitters or teachers, can also effectively administer epinephrine nasal spray.¹

The device has a shelf-life of 24 months at room temperature and tolerance to temperature exposures up to 122°F based on testing for up to 3 months. If accidentally frozen, epinephrine nasal spray can be thawed without impact on the product quality and reliability.¹

“Today’s FDA approval of [epinephrine nasal spray] 1 mg marks a major milestone towards our efforts to transform the management of severe allergic reactions,” said Richard Lowenthal, cofounder, president and chief executive officer of ARS Pharmaceuticals.¹ “Many children and caregivers fear needle-based auto-injectors, which can delay lifesaving treatment. [Epinephrine nasal spray]’s needle-free, easy-to-use design addresses this unmet need, offering families a long-awaited alternative. With nearly four out of 10 U.S. epinephrine prescriptions written for children under the age of 18—and nearly a third of those for children weighing 15 to 30 kilograms—we believe [epinephrine nasal spray] 1 mg will improve access to a needle-free option for the treatment of severe allergies and reduce hesitation in treating this vulnerable group. It will also eliminate risks like accidental needle injuries to children or caregivers.”

Since the approval of epinephrine nasal spray 2 mg in August 2024, ARS Pharmaceuticals has launched multiple programs and initiatives to improve accessibility, including neffyConnect, which offers the public information to guide their treatment journey, details about medication fulfillment services, financial support and navigating insurance requirements. In their release, ARS Pharmaceuticals pointed out epinephrine nasal spray has a cash price of $199 for 2 doses is available through BlinkRx and coupon can be downloaded from GoodRx for use at local retail pharmacies. Additionally, for some underinsured or uninsured US residents meeting eligibility criteria, the ARS Pharma Patient Assistance Program will provide epinephrine nasal spray at no cost.³

Reference:

ARS Pharmaceuticals. Ars Pharmaceuticals announces FDA approval of neffy® 1 mg (epinephrine nasal spray) for type I allergic reactions, including anaphylaxis, in pediatric patients weighing 15 to 30 kilograms. ARS Pharmaceuticals. March 5, 2025. Accessed March 6, 2025. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-announces-fda-approval-neffyr-1-mg.
ARS Pharmaceuticals. Ars Pharmaceuticals receives FDA approval of Neffy® (epinephrine nasal spray), the first and only needle-free treatment for type I allergic reactions, including anaphylaxis. ARS Pharmaceuticals. August 9, 2024. Accessed March 6, 2025. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-receives-fda-approval-neffyr-epinephrine.
ARS Pharmaceuticals. Ars Pharmaceuticals announces U.S. availability of neffy® (epinephrine nasal spray), the first and only needle-free treatment for type I allergic reactions, including anaphylaxis. ARS Pharmaceuticals. September 23, 2024. Accessed March 6, 2025. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-announces-us-availability-neffyr-epinephrine.