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: 10 Sep 2017

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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.

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

Highest Development Phases

  • Preregistration Pain

Most Recent Events

  • 30 Oct 2017 Pain Therapeutics plans pre-NDA guidance meeting with US FDA for data associated with planned NDA submission for Pain
  • 09 Aug 2017 Pain Therapeutics announces intention to resubmit NDA to the US FDA via the 505(b) pathway for Pain in the first quarter of 018 (91141)
  • 09 Aug 2017 Pain Therapeutics initiates an abuse potential phase II trial for intranasal route of abuse for oxycodone controlled release formulation
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