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A Phase 3 clinical trial trial evaluating the safety and efficacy of dronabinol (oral) for the treatment of obstructive sleep apnea

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Trial Profile

A Phase 3 clinical trial trial evaluating the safety and efficacy of dronabinol (oral) for the treatment of obstructive sleep apnea

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 10 Aug 2020

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At a glance

  • Drugs Dronabinol (Primary)
  • Indications Sleep apnoea syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors RespireRx Pharmaceuticals

    • Most Recent Events

    • 03 Aug 2020 According to a RespireRx Pharmaceuticals media release, pending the completion of a new formulation of dronabinol and an intended pre-IND meeting with the FDA, the company believes that it will be able to commence a pharmacokinetic study for the new formulation followed by phase III study for the treatment of OSA.
    • 03 Jan 2019 RespireRx planning to proceed directly to a Phase 3 pivotal trial using the currently available dronabinol formulation (2.5, 5 and 10 mg gel caps)
    • 19 Jun 2018 According to a RespireRx Pharmaceuticals media release, subjects to the outcome of an intended meeting with the FDA, the company will be able to commence this trial.

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