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A Phase 1, six-treatment, six-period, single and repeat dose, crossover study evaluating pharmacokinetics and pharmacodynamics of neffy compared with EpiPen

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Trial Profile

A Phase 1, six-treatment, six-period, single and repeat dose, crossover study evaluating pharmacokinetics and pharmacodynamics of neffy compared with EpiPen

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Nov 2024

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At a glance

  • Drugs Epinephrine (Primary)
  • Indications Anaphylaxis; Asthma; Respiratory tract disorders; Urticaria
  • Focus Pharmacodynamics; Pharmacokinetics; Registrational

    • Most Recent Events

    • 24 Oct 2024 According to an ARS Pharmaceuticals media release, data from this study will be presented on Friday, October 25 at the 2024 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting taking place in Boston, Massachusetts.
    • 09 Aug 2024 According to an ARS Pharmaceuticals media release, the U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds). Approval is based on results of four studies in 175 healthy adults.
    • 29 Dec 2022 New trial record

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