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

Trial Profile

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

Completed
Phase of Trial: Phase I

Latest Information Update: 25 Sep 2017

At a glance

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

    • 25 Sep 2017 According to an Intellipharmaceutics International media release, the FDA recommended that Intellipharmaceutics complete the relevant Category 2 and Category 3 studies to assess the abuse-deterrent properties of Oxycodone ER by the oral and nasal routes of administration and also to submit an alternate proposed proprietary name for Oxycodone ER. Intellipharmaceutics has been given one year to respond to the CRL, and can request additional time if necessary.
    • 25 Sep 2017 According to an Intellipharmaceutics International media release, company has received a Complete Response Letter (CRL) from the U.S. FDA for its Oxycodone ER New Drug Application (NDA), wherein the FDA has determined that it cannot approve the application in its present form. The FDA has requested additional information related to the inclusion of the blue dye in the Oxycodone ER formulation, which is intended to deter abuse.
    • 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.
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