Parents and pediatricians now have a new option for treating severe allergic reactions in young children. San Diego-based ARS Pharmaceuticals has received FDA approval for a needle-free alternative to the EpiPen for kids as young as four years old.

On Wednesday, the U.S. Food and Drug Administration approved the company’s 1-milligram epinephrine nasal spray, designed for children weighing between 33 and 66 pounds.

Called Neffy, the nasal spray delivers epinephrine to patients experiencing anaphylaxis, a severe allergic reaction that can be triggered by food, medication, or insect stings. Without timely treatment, anaphylaxis can be life-threatening.

Traditionally, epinephrine has been administered through injections or auto-injectors like the EpiPen. However, ARS Pharmaceuticals previously secured FDA approval in August for a 2-milligram epinephrine nasal spray, making it the first innovation in epinephrine delivery in nearly 30 years. Neffy works similarly to naloxone, the emergency nasal spray used to counter opioid overdoses.

Richard Lowenthal, CEO of ARS Pharmaceuticals, emphasized that a needle-free alternative can make epinephrine more accessible, reduce hesitation in emergencies, and eliminate needle-related injuries.

“Many children and caregivers fear injections, which can delay lifesaving treatment,” he said. “Neffy’s easy-to-use, needle-free design fills this critical gap, providing families with a long-awaited alternative.”

Dr. David Fleischer, an allergy and immunology specialist at Children’s Hospital Colorado, called the nasal spray a major advancement, particularly for pediatric patients.

“People often delay using epinephrine or rely on antihistamines first because they’re afraid of injections,” Fleischer said. “Neffy’s small, user-friendly design makes it easier for people to carry and use epinephrine quickly and confidently in an emergency. This innovation could significantly improve health outcomes and quality of life.”

The 1-milligram dose of Neffy is expected to be available in the U.S. by the end of May. ARS Pharmaceuticals is also developing a smaller dose for younger children.

For most patients with commercial insurance, two single-use Neffy nasal sprays will cost no more than $25, while uninsured patients may pay around $200 for two doses. Some may qualify for financial assistance to receive Neffy at no cost.

Since Neffy launched in mid-September, ARS Pharmaceuticals has reported $7.1 million in net product sales, with more than 14,500 two-packs delivered in 2024. The company recorded $6.5 million in fourth-quarter revenue and aims to expand insurance coverage this year.

Additionally, ARS Pharmaceuticals secured drug coverage from Express Scripts, the second-largest pharmacy benefits manager in the U.S. The company has enough funding to support operations for the next three years, with $314 million in cash, cash equivalents, and short-term investments.