FDA Approves neffy for Treatmet of Type 1 Allergic Reactions, Anaphylaxis
The approval is the first significant innovation for the delivery of epinephrine for this population in more than 35 years, according to the company news release.
The FDA approved neffy 1 mg, an epinephrine nasal spray, for the treatment of type I allergic reactions, including anaphylaxis, for children 4 years and older who weigh 15 to less than 30 kg. The approval is the first significant innovation for the delivery of epinephrine for this population in more than 35 years, according to the company news release.1
The approval is based on data from extensive clinical trials, which included data on pharmacokinetic and pharmacodynamic responses for pediatric and adult patients. | Image Credit: I Viewfinder | stock.adobe.com
“Today’s FDA approval of neffy 1 mg marks a major milestone towards our efforts to transform the management of severe allergic reactions,” Richard Lowenthal, co-founder, president, and CEO of ARS Pharma, said in the news release.1 “Many children and caregivers fear needle-based auto-injectors, which can delay lifesaving treatment. neffy’s needle-free, easy-to-use design addresses this unmet need, offering families a long-awaited alternative. With nearly 4 out of 10 US 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 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. It will also eliminate risks like accidental needle injuries to children or caregivers.”
The approval is based on data from extensive clinical trials, which included data on pharmacokinetic and pharmacodynamic responses for pediatric and adult patients. The data showed neffy 1 mg demonstrated responses consistent with those of epinephrine injection products.1
In late-breaking data at the 2024 American Academy of Allergy, Asthma, and Immunology, efficacy data showed that 100% of patients responded to a single dose of neffy within a median of 16 minutes to complete resolution of anaphylaxis symptoms. In another presentation, the drug showed significant and clinically meaningful reductions in urticaria symptoms across all end points.2
Furthermore, investigators reported that 1 of 15 patients experienced a biphasic reaction approximately 2 hours and 45 minutes after complete resolution of symptoms and required additional epinephrine treatment. For injectable products, the reported frequency of biphasic reactions is approximately 12.8% for children with food-induced anaphylaxis. The trial also had similar safety results to the previously reported safety of neffy and epinephrine products, with only 7 patients experiencing adverse events. All adverse events were mild or moderate and resolved quickly.2
Neffy consists of 3 FDA-approved components, including epinephrine, Intravail A3, and Unite Dose Spray. The pathway was established in multiple clinical trials, and the drug showed a pharmacokinetic profile that was in range with approved injectables and pharmacodynamic that is as good or better than approved injections.3
“The availability of a needle-free epinephrine option for children is a breakthrough in the treatment of severe allergic reactions,” David Fleischer, MD, section head of allergy and immunology and professor of pediatrics at Children’s Hospital Colorado, said in the news release.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. neffy’s small, user-friendly design addresses these challenges, empowering people to actually carry epinephrine and act quickly and confidently during an allergic emergency.”
Neffy is expected to be available by the end of May 2025.1
READ MORE: Allergy Resource Center
Ready to impress your pharmacy colleagues with the latest drug information, industry trends, and patient care tips? Sign up today for our free Drug Topics newsletter.
