A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active-controlled Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy

Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active-controlled Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Jan 2018

At a glance

  • Drugs Oliceridine (Primary) ; Morphine
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Acronyms APOLLO-1
  • Sponsors Trevena
  • Most Recent Events

    • 02 Jan 2018 According to a Trevena media release, the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for OLINVO (oliceridine) Injection.The Company anticipates the PDUFA date for the NDA will be in the fourth quarter of 2018.
    • 02 Nov 2017 According to a Trevena media release, company announced that it has recently submitted its New Drug Application (NDA) for OLINVOTM (oliceridine injection) to the U.S. Food and Drug Administration (FDA). Based on the data from APOLLO, ATHENA, other phase II and Phase III studies.
    • 25 Oct 2017 Trial design presented at the ANESTHESIOLOGY 2017: Annual Meeting of the American Society of Anesthesiologists
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