A clinical abuse potential study of REMOXY ER.

Trial Profile

A clinical abuse potential study of REMOXY ER.

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Mar 2018

At a glance

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

    • 19 Mar 2018 According to a Pain Therapeutics media release, the company announces FDA Advisory Committee Meeting to discuss the New Drug Application (NDA) for REMOXY ER.
    • 01 Mar 2018 According to a Pain Therapeutics media release, the U.S. Food and Drug Administration (FDA) has determined that a New Drug Application (NDA) for REMOXY ER is sufficiently complete to permit a substantive review. The FDA has set an action date of August 7, 2018 under the Prescription Drug User Fee Act (PDUFA). The Company believes the FDA will hold an open advisory committee meeting to discuss REMOXY ER.
    • 13 Feb 2018 According to a Pain Therapeutics media release, company announced the resubmission of New Drug Application (NDA) for REMOXY to the U.S. Food and Drug Administration (FDA) and expects a six-month review cycle by FDA.
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