A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Apr 2018

At a glance

  • Drugs Elagolix (Primary)
  • Indications Endometriosis; Pain
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms EM-II; Solstice
  • Sponsors AbbVie
  • Most Recent Events

    • 10 Apr 2018 According to an AbbVie media release, the U.S. Food and Drug Administration (FDA) has notified, that it requires extended time to review New Drug Application (NDA) for elagolix in endometriosis-associated pain. The Prescription Drug User Fee Act (PDUFA) date has been extended three months to Q3 2018.
    • 23 Feb 2018 Results of population pharmacokinetics of elagolix from nine clinical studies ( five phase I and four phase III), published in the Clinical Pharmacokinetics
    • 27 Oct 2017 According to an Abbvie media release, the U.S. Food and Drug Administration (FDA) has granted priority review for elagolix, being investigated for the management of endometriosis with associated pain. AbbVie expects the Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review will be in Q2 2018.
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