Oxycodone controlled release - Pain Therapeutics

Drug Profile

Oxycodone controlled release - Pain Therapeutics

Alternative Names: Extended-release oxycodone capsules CII; ORADUR®-oxycodone; Oxycodone CII; Oxycodone extended release; PF-00345439; PTI-821; Remoxy; REMOXY® ER

Latest Information Update: 08 Aug 2018

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At a glance

  • Originator DURECT Corporation
  • Developer Pain Therapeutics
  • Class Alkaloids; Morphine derivatives; Opioid analgesics; Small molecules
  • Mechanism of Action Opioid delta receptor agonists; Opioid kappa receptor agonists; Opioid mu receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No
  • Available For Licensing Yes - Pain

Highest Development Phases

  • Preregistration Pain

Most Recent Events

  • 06 Aug 2018 Pain Therapeutics receives complete response Letter from USFDA for oxycodone contolled release
  • 26 Jun 2018 Majority of members in FDA Advisory Committee Meeting votes against approval for oxycodone controlled release for Pain
  • 01 Mar 2018 US FDA accepts NDA for Oxycodone controlled release for pain for review
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