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A Two-part Open Label Study of the Pharmacodynamic Effects of Intranasal Nalmefene Compared to Intranasal Naloxone in Healthy Volunteers Under Steady State Opioid Agonism

Trial Profile

A Two-part Open Label Study of the Pharmacodynamic Effects of Intranasal Nalmefene Compared to Intranasal Naloxone in Healthy Volunteers Under Steady State Opioid Agonism

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 14 Mar 2024

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At a glance

  • Drugs Nalmefene (Primary) ; Naloxone
  • Indications Opioid-related disorders
  • Focus Pharmacodynamics; Registrational
  • Sponsors Opiant Pharmaceuticals

Most Recent Events

  • 11 Mar 2024 According to an Indivior media release, this study was a part of the OPVEE development program and reviewed by the FDA as part of the approval process. The data was collected at the primary endpoint in 50 subjects.
  • 11 Mar 2024 Primary endpoint has been met. (Change in minute ventilation) , according to Results published in an Indivior media release
  • 11 Mar 2024 Results published in an Indivior media release

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