Parents and pediatricians just gained one more tool to combat severe allergic reactions in young kids. San Diego-based ARS Pharmaceuticals received the green light from health regulators for a needle-free alternative to the EpiPen for children as young as 4 years old.
The U.S. Food and Drug Administration approved the local company’s 1 milligram dose of epinephrine nasal spray on Wednesday. It’s geared toward patients 4 years and older who weigh at least 33 to 66 pounds.
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Neffy is a nasal spray treatment that delivers epinephrine to patients experiencing symptoms from a severe allergic reaction, or anaphylaxis. These intense reactions can be triggered by food, medication or insect stings. Extreme cases of untreated anaphylaxis can lead to death.
The only treatment to quell the allergic reaction is epinephrine, which historically has been administered through shots or auto-injectors, such as the EpiPen.
In August, ARS Pharmaceuticals received the first FDA approval for a 2 milligram dose of epinephrine nasal spray. The device is similar to the delivery method for nalaxone, the emergency nasal spray treatment for opioid overdose.
San Diego-based ARS Pharmaceuticals received FDA approval for its 1 milligram dose of Neffy, an epinephrine nasal spray. The new dose is geared toward patients as young as 4 years old. (ARS Pharmaceuticals)
Richard Lowenthal, CEO of ARS Pharmaceuticals, said in this week’s announcement that having a needle-free option for young children will expand access to the essential medicine, reduce hesitation and eliminate needle-related injuries.
“Many children and caregivers fear needle-based auto-injectors, which can delay lifesaving treatment,” he said. “Neffy’s needle-free, easy-to-use design addresses this unmet need, offering families a long-awaited alternative.”
Neffy is the first FDA-approved innovation for delivering epinephrine in about three decades. The company chose the name for the product because it’s easy to say and doesn’t sound intimidating to children.
Dr. David Fleischer, a professor of pediatrics and section head of Allergy and Immunology at Children’s Hospital Colorado, said in the announcement that this kind of nasal spray is a breakthrough treatment, particularly for children.
“Many people wait to administer epinephrine until symptoms progress or take antihistamines as a first line of defense because they are afraid of injection,” Fleischer said. “Neffy’s 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.”
The 1 milligram dose of Neffy is expected to be available in the United States by the end of May. The company said in an email to the Union-Tribune that it is working on a smaller dose of Neffy for younger children.
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For most patients with commercial insurance coverage, the company said two, single-use Neffy nasal sprays will cost no more than $25. Without insurance, two doses cost about $200, though there are options for some patients to receive the product at no cost through the company.
Earlier this year, ARS Pharmaceuticals reported its preliminary fourth-quarter earnings for the three-month period ending Dec. 31.
ARS Pharma recorded about $7.1 million in net product sales of Neffy, since it became available in mid-September, and more than 14,500 two-packs of Neffy delivered in 2024. Net product revenue for Neffy during the fourth quarter was about $6.5 million, according to SEC filings.
During the quarter Neffy also received coverage from Express Scripts, the second-largest pharmacy benefits manager in the U.S. This year, the company is aiming to expand commercial coverage for the product.
The company also reported that it has sufficient funding for operations over the next three years with cash, cash equivalents and short-term investments worth $314 million.
