The New Drug Application (NDA) for neffy®, an intranasal formulation of epinephrine, has been accepted for review by the Food and Drug Administration (FDA) for the emergency treatment of allergic reactions (type 1), including anaphylaxis in adults and children weighing at least 30kg.

The application is supported by data from 4 primary registration studies demonstrating that the nasal spray formulation was bioequivalent to epinephrine injection. Additionally, intranasal epinephrine was found to be absorbed quicker (20 minutes vs 45 minutes for intramuscular injection) resulting in a significant improvement in hemodynamic response.

Similar results were observed following induction of rhinitis in the EPI-04 study. When administered to study participants with severe congestion and edema, the maximum plasma exposure with intranasal epinephrine remained within the range of FDA-approved doses of epinephrine injection.

Across more than 500 study participants, including children (≥30kg), intranasal epinephrine was found to be well tolerated with no significant nasal pain or irritation.

A Prescription Drug User Fee Act (PDUFA) target date for mid-2023 has been assigned to the application. If approved, this would be the first needle-free option for treating severe allergic reactions.

References

  1. Silverback Therapeutics, Inc. announces the FDA’s acceptance of ARS Pharmaceuticals’ NDA for neffy® (epinephrine nasal spray) for the treatment of allergic reactions (type I) including anaphylaxis. News release. October 21, 2022. https://www.businesswire.com/news/home/20221021005114/en/Silverback-Therapeutics-Inc.-announces-the-FDA%E2%80%99s-acceptance-of-ARS-Pharmaceuticals%E2%80%99-NDA-for-neffy%C2%AE-epinephrine-nasal-spray-for-the-Treatment-of-Allergic-Reactions-type-I-including-Anaphylaxis
  2. ARS Pharmaceuticals announces results from EPI-04 clinical study of ARS-1 intranasal epinephrine spray in allergy patients with allergic rhinitis. News release. June 4, 2019. https://ars-pharma.com/2019/06/04/ars-pharmaceuticals-announces-results-from-epi-04-clinical-study-of-ars-1-intranasal-epinephrine-spray-in-allergy-patients-with-allergic-rhinitis/
  3. Lockey R, Simons FE, eta l. Comparison of the pharmacokinetics and pharmacodynamics of epinephrine after intranasal (IN), intramuscular (IM) and subcutaneous (SC) administration in three landmark studies. Published online February 1, 2020. The Journal of Allergy and Clinical Immunology. doi.org/10.1016/j.jaci.2019.12.669
  4. Tanimoto S, Simons FE, et al. A phase 1, five-period, five-treatment, randomized crossover study of the pharmacokinetics (PK) and pharmacodynamics (PD) of epinephrine after administration of intranasal (IN) ARS-1 and intramuscular (IM) epinephrine to healthy volunteers. Published online February 1, 2020. The Journal of Allergy and Clinical Immunology. doi.org/10.1016/j.jaci.2019.12.668.