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A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder

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Trial Profile

A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2023

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At a glance

  • Drugs Mirabegron (Primary) ; Solifenacin (Primary)
  • Indications Overactive bladder
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms SYNERGY II
  • Sponsors Astellas Pharma Europe Ltd
  • Most Recent Events

    • 07 May 2018 According to an Astellas Pharma media release, the U.S. Food and Drug Administration (FDA) FDA Approves Supplemental New Drug Application for Myrbetriq (mirabegron) for Use in Combination with solifenacin succinate for the Treatment of Overactive Bladder Symptoms.
    • 12 Sep 2017 According to an Astellas Pharma media release, the U.S. Food and Drug Administration (FDA) has accepted for review of a supplemental New Drug Application (sNDA) that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The anticipated Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 28, 2018.
    • 29 Jun 2017 According to an Astellas Pharma media release, the company has submitted a supplemental New Drug Application (sNDA) to the US FDA seeking approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. The sNDA submission is based on data from the global Phase 3 SYNERGY I, SYNERGY II and BESIDE studies.
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