A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate with Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects with Overactive Bladder
Phase of Trial: Phase III
Latest Information Update: 03 Aug 2017
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
- 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 Primary endpoint (Change from baseline in mean number of micturitions per 24 hours at EoT) has been met as per the results presented at the 112th Annual Meeting of the American Urological Association.
- 16 May 2017 Primary endpoint (Change from baseline in mean number of incontinence episodes per 24 hours at EoT) has been met as per the results presented at the 112th Annual Meeting of the American Urological Association.