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A multi-site, single treatment pediatric study designed to evaluate the PK, pharmacodynamics (PD), safety, and tolerability of Anaphylm (epinephrine) Sublingual Film

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Trial Profile

A multi-site, single treatment pediatric study designed to evaluate the PK, pharmacodynamics (PD), safety, and tolerability of Anaphylm (epinephrine) Sublingual Film

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Apr 2025

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At a glance

  • Drugs Epinephrine (Primary)
  • Indications Hypersensitivity
  • Focus Pharmacokinetics

    • Most Recent Events

    • 04 Apr 2025 New trial record
    • 01 Apr 2025 Positive pharmacokinetic (PK) results (n=32) were published in the Aquestive Therapeutics media release.
    • 01 Apr 2025 According to Aquestive Therapeutics media release, company completes submission of its New Drug Application (NDA) for Anaphylm to the FDA; NDA acceptance expected in Q2 2025

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