Neffy 1 mg, from ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) achieved a significant regulatory milestone as the United States Food and Drug Administration (FDA) approved the epinephrine nasal spray to treat Type I Allergic Reactions such as anaphylaxis in children four years and older who are weighing 15 to 30 kilograms (33 to 66 lbs.). Epinephrine delivery made history with this breakthrough as it is the first breakthrough for the age group over the past three decades.
Research shows that one in every 13 children has a serious food allergy, and more than 40% experience severe allergic reactions. Facts show that patients administer epinephrine 40 percent later and caregivers 50 percent of the time because they fear using needle-injector auto-injectors even though prompt epinephrine administration leads to better outcomes. Neffy provides precise drug delivery through nasal sprays that eliminates the need for holding the nose, enhancing emergency allergy treatment to patients.
Richard Lowenthal, President and CEO of ARS Pharma, highlighted the pioneering aspect of the neffy solution in his press release. The needle-free aspect of neffy overcomes injection phobia between caregivers and patients to enable faster administration of effective therapy. Based on the high volume of epinephrine prescriptions for children in the U.S., this product will essentially enhance access to allergy treatment and emergency management confidence, Lowenthal added.
Pharmacokinetic (PK) and pharmacodynamic (PD) response clinical trials contrasted neffy 1 mg in children and adults and found the same efficacy as with regular epinephrine injections. Clinical trials indicated that the side effects of treatment had negligible and short-term impacts on child patients. The study found that ten-year-old children and non-medically trained staff such as teachers and babysitters could utilize the spray effectively after the given instruction guidelines.
The neffy product is stable for 24 months at regular room temperature and can withstand three months of 122°F (50°C) heat exposure without degrading. Frozen neffy can be thawed without compromising its performance while preserving its quality.
Dr. David Fleischer, from the Allergy & Immunology Section at Children’s Hospital Colorado announced the approval of a milestone in allergy treatment. Many people have been deterred from administering epinephrine during allergic emergencies because of the needle phobia, so neffy is a needle-free epinephrine injector, which provides easy access to instant treatment of allergic emergencies. The technology holds out the promise of better outcomes as well as a better quality of life for many people, according to his assessment.
The neffy 1 mg remains available from the ARS Pharma team across the U.S. from the start of May 2025, with the patient-friendly pricing intact. The company’s neffyConnect service helps patients and caregivers with complete medication assistance and helps them with prescription requirements along with insurance resource assistance and financial assistance capabilities. Commercial health insurance customers will receive single-use devices at a maximum of $25 via the co-pay savings program. The ARS Pharma Patient Assistance Program (PAP) offers the product free of charge to patients with inadequate coverage or who are uninsured and who qualify under certain criteria.
The FDA approved neffy 2 mg in adult patients on August 9, 2024, and the European Commission (EC) approved EURneffy on August 22, 2024, in patients weighing more than 30 kg (66 lbs.). The regulatory guidelines reflect increased acceptance of needle-free solutions for treating severe allergies.
The neffy nasal spray is an immediate medication to relieve Type I allergic reactions and anaphylaxis in patients aged four and older with a body weight of not less than 33 lbs. The medication provides rapid relief from allergic emergency conditions beyond basic epinephrine auto-injectors.
There should always be two doses in the case of chronic or recurrent anaphylactic symptoms for a patient. Drug treatment initially followed by prompt medical treatment after the administration of a second dose five minutes later is the treatment for Type I allergic reactions in case of an emergency.
Epinephrine is the sole FDA-approved medication for the management of anaphylaxis, whereas neffy is not suitable for those who have already demonstrated epinephrine hypersensitivity. Those with cardiovascular disease or hypertension and thyroid disease or diabetes should seek medical permission before trying neffy.
The most common side effects reported are nasal reactions, headache, sore throat, dizziness, and nasal discharge. The FDA approved ARS Pharmaceuticals’ neffy 1 mg that introduced a new generation of allergy therapy by surmounting the inherent challenges in epinephrine delivery. The innovation circumvents needle phobia to enable timely and effective interventions in the most severe allergic reactions that save children’s lives.
References: FDA approval of neffy® 1 mg (epinephrine nasal spray) for type I allergic reactions, including anaphylaxis, in pediatric patients weighing 15 to < 30 kilograms. Published March 5, 2025. ARS Pharmaceuticals. https://ir.ars-pharma.com/news-releases/news-release-details/ars-pharmaceuticals-announces-fda-approval-neffyr-1-mg
