A Long-Term Open-Label Safety Study of Hydrocodone Bitartrate Controlled-Release Capsules With Flexible Dosing to Treat Subjects With Moderate to Severe Chronic Pain.

Trial Profile

A Long-Term Open-Label Safety Study of Hydrocodone Bitartrate Controlled-Release Capsules With Flexible Dosing to Treat Subjects With Moderate to Severe Chronic Pain.

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jun 2015

At a glance

  • Drugs Hydrocodone (Primary)
  • Indications Pain
  • Focus Adverse reactions; Registrational
  • Sponsors Zogenix
  • Most Recent Events

    • 21 May 2013 An NDA submitted in March 2013 is anticipated to be reviewed by the FDA in the second half of 2013, according to the Q1 2013 financial report released by Zogenix.
    • 07 Dec 2012 Results from this trial were included in a NDA submitted to the US FDA.
    • 30 Sep 2011 The results are being analysed and will be submitted to the US FDA in early 2012, according to a Zogenix media release.
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