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
Phase of Trial: Phase III
Latest Information Update: 31 Jul 2017
At a glance
- Drugs Mirabegron (Primary) ; Solifenacin (Primary)
- Indications Overactive bladder
- Focus Therapeutic Use
- Acronyms BESIDE
- Sponsors Astellas Pharma
- 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.
- 16 Apr 2017 Results assessing cardiovascular safety of the mirabegron and solifenacin combination therapy, published in the International Journal of Clinical Practice