索非那新/盐酸坦索罗辛复方缓释片 Vesomni 6mg/0,4mg-安斯泰来BPH药物首个获欧盟批准上市
安斯泰来（Astellas）宣布，荷兰药品评价委员会（MEB）已批准了VESOMNI的上市许可申请（MAA），VESOMNI通过欧盟成员国相互互认程序方式获得批准。VESOMNI用于对单药疗法无足够响应的良性前列腺增生症（BPH）男性患者中度至重度储尿（storage symptoms）及排尿（voiding symptoms）困难的治疗。VESOMNI是一种每日一次的薄膜包衣、双层修饰释放片剂，每片含6mg 抗胆碱索非那（antimuscarinic solifenacin）和0.4mg α1-肾上腺素能受体拮抗剂（α1-受体阻滞剂）坦洛新（tamsulosin），膀胱活动过度症治疗药solifenacin和BPH治疗药tamsulosin的固定剂量复合剂。其中tamsulosin 于2006年3月在欧洲失去专利保护。

Product Name: VESOMNI 6 MG/0.4 MG MODIFIED RELEASE TABLETS
VESOMNI 6 mg/0,4 mg - Tabletten mit veraenderter Wirkstofffreisetzung XL.  - 135278 - ASTELLAS PHARMA EUROPE B.V., LEIDEN, NL-BE LEIDEN - ASTELLAS PHARMA GMBH, WIEN
Vesomni: combination tablet for urinary storage symptoms associated with BPH
Vesomni is a fixed-dose, modified-release combination tablet containing tamsulosin and solifenacin that is indicated for the treatment of moderate to severe storage symptoms and voiding symptoms associated with BPH, when the response to treatment with monotherapy is inadequate.
NICE recommends considering an anticholinergic in combination with an alpha-blocker for men who still have storage symptoms after treatment with an alpha-blocker alone.
PHARMACOLOGY
Tamsulosin is an alpha1 adrenoceptor antagonist that reduces smooth muscle tone in the prostate and bladder neck to increase urine flow. Solifenacin is a competitive and selective muscarinic receptor antagonist that reduces urinary urgency and frequency.1
CLINICAL STUDIES
The safety and efficacy of tamsulosin/solifenacin was established in the double-blind phase III NEPTUNE trial. The trial included 1,334 men who had storage and voiding lower urinary tract symptoms (LUTS) associated with BPH, defined as ≥2 urgency episodes per 24 hours, ≥8 micturitions in the 24 hours preceding randomisation, an International Prostate Symptom Score (IPSS) ≥13, a maximum urinary flow rate 4.0−12.0ml/s and a voided volume of ≥120ml during free flow.
Patients were randomised to receive placebo, a fixed-dose combination of tamsulosin and solifenacin, or tamsulosin alone for 12 weeks.2
Non-inferior to tamsulosin monotherapy
Combination therapy with 400 microgram tamsulosin plus solifenacin 6mg produced a significantly greater reduction from baseline than placebo in the primary endpoint, total IPSS [-7.0 vs -5.4 (p<0.001)], and was non-inferior to tamsulosin monotherapy for this endpoint (p=0.001; change from baseline -7.0 vs -6.2).2
The combination showed superiority to placebo and tamsulosin monotherapy in terms of the other primary endpoint, total urgency and frequency score (changes from baseline -8.1 vs -4.4 [p<0.001] and -6.7 [p<0.05], respectively).2
Improved quality of life
Patients receiving the combination tablet also reported significant improvements in IPSS and Overactive Bladder Questionnaire (OAB-q) quality of life scores (p<0.001 vs placebo; p<0.01 vs tamsulosin alone) and OAB-q sleep subscore (p<0.01 and p<0.05 vs placebo and tamsulosin, respectively).2
Tolerability
Tamsulosin/solifenacin was generally well tolerated. The most common adverse effects, including dry mouth, constipation and dyspepsia, reflect those typically associated with anticholinergics. Acute urinary retention was the most serious adverse effect but occurred in less than 1% of patients.1,2
NICE  recommendation
NICE recommends considering an anticholinergic in combination with an alpha-blocker for men who still have storage symptoms after treatment with an alpha-blocker alone.3
Generic Name: solifenacin + tamsulosin  
Trade Name: Vesomni 
Synonym: EC905 
Entry Type: New formulation  
Developmental Status
UK: Launched 
EU: Launched 
US: None 
UK launch Plans: Available only to registered users
Actual UK launch date: 01/02/2014 
Comments
Feb 14: Launched in the UK for treatment of men with lower urinary tract symptoms. Net price: £27.62 for 30 x 6mg/0.4mg tabs [7].
03/02/2014 11:45:13 
Nov 13: Launched in the Netherlands for the treatment of moderate to severe storage symptoms (urgency and increased micturition frequency) and voiding symptoms associated with BPH, in patients not responding adequately to monotherapy [6].
06/12/2013 17:52:19 
May 13: Approved in the EU [6].
06/12/2013 17:50:43 
Mar 12: Filed in the Netherlands via the EU decentralised procedure [3].
28/03/2012 15:45:23 
PIII in the EU [1].
07/03/2011 14:36:09 
Trial or other data
Mar 13: NCT01018511 was completed in March 2011 [5]. 
08/03/2013 16:01:23
NEPTUNE II is a PIII open-label extension study (NCT01021332) investigating long-term efficacy & safety of the solifenacin/tamsulosin oral controlled absorption system (OCAS) over 52 weeks. The study will recruit 800 pts & will complete in May 11. The primary outcome measures include incidence & severity of AEs; secondary outcome measures are change from baseline to endpoint in data from micturition diary, & I-PSS questionnaire [2].
02/03/2011 10:38:56
The PIII NEPTUNE (NCT01018511) study is examining the efficacy, safety & tolerability of combination therapy of tamsulosin and solifenacin compared to monotherapy of tamsulosin in the treatment of males with LUTS associated with BPH with a substantial storage component. Two fixed dose combinations of 6mg and 9mg solifanacin with 400micrograms tamsulosin will be studied over 12 weeks a& the primary outcome is change from baseline to endpoint in total International Prostate Symptom Score. 1,713 patients will be enrolled at sites in the UK, Austria, Belarus, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, Russia & Slovakia. The study is expected to complete in Feb 11 [2]. 
02/03/2011 10:32:49
Evidence Based Evaluations
EPAR  http://db.cbg-meb.nl/Pars/h111622.pdf 
SMC  References  
Available only to registered users
 Category
BNF Category: Drugs for urinary retention (07.04.01)
Pharmacology: Antimuscarinic agent & alpha-blocker combination  
Epidemiology: BPH affects the quality of life of about a third of men over 50 years, the numbers increasing markedly with years. Histological evidence of BPH occurs in up to 90% of men by the age of 80. [4]  
Indication: Benign prostatic hyperplasia 
Additional Details: associated-lower urinary tract symptoms (inc storage symps) 
Method(s) of Administration  
Oral 
Company Information
Name: Astellas 
US Name: Astellas