A Phase 3 Multi-Center Actual-Use Study on the Safety of CL 108 for the Treatment of Moderate to Severe Acute Pain Associated With Osteoarthritis of the Knee or Hip

Trial Profile

A Phase 3 Multi-Center Actual-Use Study on the Safety of CL 108 for the Treatment of Moderate to Severe Acute Pain Associated With Osteoarthritis of the Knee or Hip

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Feb 2017

At a glance

  • Drugs Promethazine/hydrocodone/paracetamol (Primary)
  • Indications Musculoskeletal pain
  • Focus Adverse reactions; Registrational
  • Sponsors Charleston Laboratories
  • Most Recent Events

    • 03 Feb 2017 According to a Charleston Laboratories and Daiichi Sankyo media release, the U.S. FDA has issued a Complete Response Letter (CRL) regarding the NDA for CL-108. The CRL stated that the NDA in its present form was not approved and provided guidance on information needed to resolve matters identified.
    • 30 Sep 2016 Results presented at the 16th World Congress on Pain
    • 13 Jun 2016 According to a Charleston Laboratories media release, the US FDA has accepted for review the NDA for CL-108 for the relief of moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting (OINV). The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of January 31, 2017.
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