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A clinical study of oliceridine in healthy volunteers

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Trial Profile

A clinical study of oliceridine in healthy volunteers

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 17 Mar 2020

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At a glance

  • Drugs Oliceridine (Primary)
  • Indications Acute pain
  • Focus Adverse reactions; Registrational
  • Sponsors Trevena

Most Recent Events

  • 05 Mar 2020 According to an Trevena media release, U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmitted New Drug Application (NDA) for IV oliceridine, the lead investigational asset for the management of moderate-to-severe acute pain. A Prescription Drug User Fee Act (PDUFA) goal date has been set for August 7, 2020.
  • 10 Feb 2020 According to an Trevena media release, the company announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for IV oliceridine for the management of moderate-to-severe acute pain. The Company anticipates a six-month review period by FDA.
  • 04 Nov 2019 Top-line Results published in Trevena Media Release

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