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A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Single-Dose,4-Way Crossover Study With Exploratory Fifth Treatment to Determine the Relative Nasal Abuse Potential of PTI-821 (Oxycodone Extended-Release Capsules)

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Single-Dose,4-Way Crossover Study With Exploratory Fifth Treatment to Determine the Relative Nasal Abuse Potential of PTI-821 (Oxycodone Extended-Release Capsules)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 09 Jul 2019

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At a glance

  • Drugs Oxycodone (Primary) ; Oxycodone
  • Indications Pain
  • Focus Pharmacodynamics; Registrational
  • Sponsors Cassava Sciences; Pain Therapeutics

    • Most Recent Events

    • 07 Jan 2019 According to a Pain Therapeutics media release, results form this study were published in the Journal of Opioid Management.
    • 26 Jun 2018 In a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA), majority of the members (14/3) voted against the approval of oxycodone controlled-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, according to a Pain Therapeutics media release.
    • 19 Mar 2018 According to a Pain Therapeutics media release, the company announces FDA Advisory Committee Meeting to discuss the New Drug Application (NDA) for REMOXY ER.

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