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A clinical study to assess the pharmacokinetics, pharmacodynamics of 1mg of intranasal epinephrine spray (ARS 1) compared with intramuscular (0.3mg or 0.5mg) or subcutaneous (0.3mg) injection of epinephrine in patients with seasonal allergies

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Trial Profile

A clinical study to assess the pharmacokinetics, pharmacodynamics of 1mg of intranasal epinephrine spray (ARS 1) compared with intramuscular (0.3mg or 0.5mg) or subcutaneous (0.3mg) injection of epinephrine in patients with seasonal allergies

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 24 Mar 2025

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At a glance

  • Drugs Epinephrine (Primary) ; Epinephrine; Epinephrine
  • Indications Anaphylaxis
  • Focus Pharmacodynamics; Pharmacokinetics

Most Recent Events

  • 20 Mar 2025 According to an ARS Pharmaceuticals media release, neffy 1 mg is expected to be available in U.S. pharmacies starting in May 2025.
  • 05 Mar 2025 According to an ARS Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has approved neffy 1 mg (epinephrine nasal spray) for the treatment of Type I Allergic Reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15 to < 30 kilograms (33 to < 66 lb.).
  • 13 Nov 2024 According to an ARS Pharmaceuticals media release, in November 2024, the FDA granted the sNDA priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025.

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