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Phase I open-label, laboratoty-blinded, randomized, crossover trial comparing Rexista oxycodone XR to Oxycontin under single dose fasting conditions

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Trial Profile

Phase I open-label, laboratoty-blinded, randomized, crossover trial comparing Rexista oxycodone XR to Oxycontin under single dose fasting conditions

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 Jul 2020

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At a glance

  • Drugs Oxycodone (Primary)
  • Indications Pain
  • Focus Pharmacokinetics; Registrational

    • Most Recent Events

    • 02 Jul 2020 According to an Intellipharmaceutics International media release, company and Purdue Pharmaceuticals entered into a stipulated dismissal agreement to terminate Prude Pharma's patent litigation regarding the NDA filing for oxycodone controlled release with the US FDA, subject to approval by the court.
    • 16 Jan 2020 According to an Intellipharmaceutics International media release, there can be no assurance that the FDA will ultimately approve the NDA for the sale of Aximris XR in the U.S. market, or that it will ever be successfully commercialized.
    • 16 Jan 2020 According to an Intellipharmaceutics International media release, 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) voted to not support the approval of Aximris XR (oxycodone extended-release tablets) 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.

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