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A Randomized, Open label, Pharmacokinetic study to evaluate the bioavailability of nasally administered naloxone formulations to Narcan nasal spray

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Trial Profile

A Randomized, Open label, Pharmacokinetic study to evaluate the bioavailability of nasally administered naloxone formulations to Narcan nasal spray

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 30 Nov 2023

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At a glance

  • Drugs Naloxone (Primary)
  • Indications Opioid-related disorders
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 28 Nov 2023 According to Orexo media release, the New Drug Application (NDA) for OX124 has been accepted for review by the US Food and Drug Administration (FDA).Prescription Drug User Fee Act date (PDUFA) set to July 15, 2024. If approved, US launch is expected to be initiated late 2024.
    • 03 Apr 2023 According to Orexo media release, the company expects to resubmit the file during Q3 2023 with approval expected second half of 2024.
    • 03 Apr 2023 According to Orexo media release, the expected US launch of OX124 is delayed to late 2024 from previously first half of 2024, if approved by the US Food and Drug Administration (FDA) according to their ordinary timelines.
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