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Pivotal bioequivalence trial of modified vs original REMOXY [oxycodone extended-release capsules].

Trial Profile

Pivotal bioequivalence trial of modified vs original REMOXY [oxycodone extended-release capsules].

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 27 Mar 2019

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At a glance

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

    • 06 Aug 2018 According to a Pain Therapeutics media release, company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for REMOXY. According to the FDA, the data submitted in the NDA do not support the conclusion that the benefits of [REMOXY] Extended-Release Capsules outweigh the risks.
    • 26 Jun 2018 In a 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), majority of the members (14/3) voted against the approval of oxycodone controlled-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, according to a Pain Therapeutics media release.
    • 11 May 2015 Status changed from not yet recruiting to completed, as reported in a Pain Therapeutics media release.
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