A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects who have Received Solifenacin for 4 Weeks and Warrant Additional Relief for their OAB Symptoms

Trial Profile

A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects who have Received Solifenacin for 4 Weeks and Warrant Additional Relief for their OAB Symptoms

Completed
Phase of Trial: Phase III

Latest Information Update: 11 Oct 2017

At a glance

  • Drugs Mirabegron (Primary) ; Solifenacin (Primary)
  • Indications Overactive bladder
  • Focus Registrational; Therapeutic Use
  • Acronyms BESIDE
  • Sponsors Astellas Pharma
  • Most Recent Events

    • 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.
    • 16 May 2017 Results presented at the 112th Annual Meeting of the American Urological Association.
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