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

Trial Profile

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

Completed
Phase of Trial: Phase I

Latest Information Update: 30 Jun 2017

At a glance

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

    • 30 Jun 2017 According to an Intellipharmaceutics International media release, 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") has been scheduled for July 26, 2017 to review the Company's New Drug Application ("NDA") for RexistaTM abuse-deterrent oxycodone hydrochloride extended release tablets.
    • 02 Feb 2017 According to an Intellipharmaceutics International media release, the US FDA has accepted for review a New Drug Application ("NDA") seeking authorization to market Rexista abuse-deterrent oxycodone hydrochloride extended release tablets in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths.
    • 25 Nov 2016 According to an Intellipharmaceutics International Inc. media release, company has filed a New Drug Application ("NDA") with the U.S. Food and Drug Administration ("FDA") seeking authorization to market its Rexista abuse-deterrent oxycodone hydrochloride extended release tablets in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths.
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