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New Drugs Online Report for solifenacin succinate
Generic Name:
solifenacin succinate 
Trade Name: Vesicare 
Entry Type: Licence extension / variation  
Development and Regulatory status
UK: Phase III Clinical Trials 
EU: Phase III Clinical Trials 
US: Phase III Clinical Trials 
UK launch Plans: Available only to registered users
Actual UK launch date:  
May 14: Will be filed via the EU centralised procedure [4]. 
13/05/2014 12:34:53
Trial or other data
NCT00629642 is a randomized, double blind PIII study to evaluate the efficacy and safety of solifenacin succinate (5 and 10mg once daily) vs placebo and oxybutynin hydrochloride (5 mg three times daily) in the treatment of 249 subjects with neurogenic detrusor overactivity due to multiple sclerosis (EDSS≤8) or spinal cord injury (partial or complete lesions). The study completed in 2011 [1]. 
18/03/2013 10:42:42
Available only to registered users
BNF Category:
Drugs for urinary frequency, enuresis, and incontinence (07.04.02)
Pharmacology: Quinuclidine high-affinity competitive muscarinic M3 receptor antagonist  
Epidemiology: Neurogenic detrusor overactivity is often a symptom of a neurological disease, such as multiple sclerosis and spinal cord injury. In England and Wales, there are 100-140 per 100,000 people living with MS; ~75% experience bladder problems during the course of the disease [2,3]  
Indication: Neurogenic detrusor overactivity 
Additional Details: in adults 
Method(s) of Administration
Company Information
Name: Astellas 
US Name: Astellas 
Further Information
Anticipated commissioning route (England)
High cost drug list? Awaiting Update
Implications Available only to registered users