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A pivotal pharmacokinetic bridging study of OX124

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Trial Profile

A pivotal pharmacokinetic bridging study of OX124

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 19 Jul 2024

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At a glance

  • Drugs Naloxone (Primary)
  • Indications Opioid-related disorders
  • Focus Pharmacokinetics; Registrational
  • Sponsors Orexo

Most Recent Events

  • 16 Jul 2024 According to Orexo media release, the company has received a complete response letter from the US FDA regarding the NDA requesting additional technical data on the final commercial product has been requested. The CRL does not indicate a need for additional clinical or non-clinical studies. The company will work with FDA for to address this to enable a resubmission of the NDA to FDA as soon as possible. The review period following the resubmission of the NDA will be up to six month.
  • 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.

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