Delving into the Latest Updates on Solifenacin Succinate/Tamsulosin Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Vesomni

+ [1]

Target

M3 receptor x α1A-AR

Action

antagonists

Mechanism

M3 receptor antagonists(Muscarinic acetylcholine receptor M3 antagonists), α1A-AR antagonists(Alpha-1a adrenergic receptor antagonists)

Therapeutic Areas

Other Diseases

Active Indication

Lower Urinary Tract Symptoms

Inactive Indication

DysuriaProstatic HyperplasiaUrinary Bladder, Overactive

Originator Organization

Astellas Pharma, Inc.

Active Organization

Astellas Pharma, Inc.

Inactive Organization

Astellas Pharma Europe Ltd.

Drug Highest PhaseApproved

First Approval Date

Netherlands (07 Oct 2013),

Lower Urinary Tract Symptoms

Regulation-

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Structure/Sequence

Molecular FormulaC20H29ClN2O5S

InChIKeyZZIZZTHXZRDOFM-XFULWGLBSA-N

CAS Registry106463-17-6

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AbstractAimTo evaluate the impact of Vesomni/Urizia/Volutsa, a fixed‐dose combination tablet containing 6 mg solifenacin (antimuscarinic) and 0.4 mg tamsulosin (α‐blocker), on health‐related quality of life (HRQoL) and treatment satisfaction in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in routine clinical practice.MethodsEUROPA was a noninterventional study of men with LUTS/BPH not responding to monotherapy who were prescribed Vesomni in routine clinical practice. Data were collected retrospectively (1 year) and prospectively (1 year). Assessments were performed at baseline, weeks 4 to 8, weeks 9 to 18 (optional), weeks 19 to 39 (optional), and Weeks 40 to 52. The primary endpoint was change from baseline in HRQoL, as assessed by the Overactive Bladder Questionnaire (OAB‐q) symptom bother subscale score. Change from baseline in OAB‐q total and coping, sleep, and social interaction subscale scores, treatment satisfaction‐visual analog scale (TS‐VAS), International Prostate Symptom Score (IPSS), and European Quality of Life 5‐Dimension‐5‐Level (EQ‐5D‐5L) questionnaire were also evaluated.ResultsFive hundred and eighty‐nine patients were enrolled. The mean changes in adjusted mean (95% confidence interval [CI]) OAB‐q symptom bother subscale scores were −16.40 (−24.31, −8.49) at weeks 4 to 8 and −19.59 (−28.26, −10.92) at weeks 40 to 52; at weeks 40 to 52, changes were clinically meaningful in 84.6% of patients. Adjusted mean (95% CI) change from baseline to weeks 40 to 52 were 15.02 (7.35, 22.69), 19.37 (10.86, 27.89), 18.65 (7.44, 29.86), 9.85 (3.90, 15.81), and 16.09 (9.07, 23.11) for concern, coping, sleep, social interaction, and total, respectively. TS‐VAS, IPSS, and EQ‐5D‐5L all improved, and treatment persistence at weeks 40 to 52 was 77.1%. Urinary retention was reported in four (0.7%) patients.ConclusionsVesomni was well‐tolerated and improved HRQoL and treatment satisfaction in patients with LUTS/BPH.

100 Deals associated with Solifenacin Succinate/Tamsulosin Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	G04CA53	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Lower Urinary Tract Symptoms	Netherlands	Astellas Pharma, Inc.	07 Oct 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Lower Urinary Tract Symptoms	Discovery	Poland	Astellas Pharma Europe Ltd.	11 Jan 2010
Lower Urinary Tract Symptoms	Discovery	Hungary	Astellas Pharma Europe Ltd.	11 Jan 2010
Lower Urinary Tract Symptoms	Discovery	Russia	Astellas Pharma Europe Ltd.	11 Jan 2010
Lower Urinary Tract Symptoms	Discovery	Austria	Astellas Pharma Europe Ltd.	11 Jan 2010
Lower Urinary Tract Symptoms	Discovery	Belarus	Astellas Pharma Europe Ltd.	11 Jan 2010
Lower Urinary Tract Symptoms	Discovery	France	Astellas Pharma Europe Ltd.	11 Jan 2010
Lower Urinary Tract Symptoms	Discovery	Germany	Astellas Pharma Europe Ltd.	11 Jan 2010
Lower Urinary Tract Symptoms	Discovery	Slovakia	Astellas Pharma Europe Ltd.	11 Jan 2010
Lower Urinary Tract Symptoms	Discovery	Belgium	Astellas Pharma Europe Ltd.	11 Jan 2010
Lower Urinary Tract Symptoms	Discovery	United Kingdom	Astellas Pharma Europe Ltd.	11 Jan 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01021332 (Neptune II, CTgov)	Phase 3	Prostatic Hyperplasia \| Lower Urinary Tract Symptoms	1,067	tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)	ajnsebsvqf(ppvoxhbfnn) = derqqjzint tyulbkdxpp (zfdlqmftrn, jwyhlvuqoi - esagybmizg) View more	-	22 Jan 2016
NCT01018511 (Neptune, CTgov)	Phase 3	Prostatic Hyperplasia \| Lower Urinary Tract Symptoms	1,334	Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg (Placebo)	slznopnqbz(ruawodkgqe) = hxzxtreimk byciewjlxk (thlbsfhdbr, dooumdidai - sdpfjqkgoj) View more	-	17 Dec 2015
				Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg+tamsulosin hydrochloride OCAS 0.4 mg (TOCAS 0.4 mg)	slznopnqbz(ruawodkgqe) = vhvijgxnkb byciewjlxk (thlbsfhdbr, xanvvnjmkh - ziiltxopjs) View more
NCT01533597 (CTgov)	Phase 4	Urinary Bladder, Overactive	70	Solifenacin (Solifenacin)	hbxnaufasi(gpuszjjqtl) = ygwuztvjgn ygtazqludi (kctogspkro, bencfpmbzc - qryeweqtaq) View more	-	27 Jan 2015
				Solifenacin plus Tamsulosin (Solifenacin Plus Tamsulosin)	hbxnaufasi(gpuszjjqtl) = awknllghqn ygtazqludi (kctogspkro, myuvimnhcm - hctivwjrou) View more
AUA2014	Not Applicable	Prostatic Hyperplasia	155	Solifenacin 5 mg/day	(fxdivnmusb) = 1 case had blurred vision gmffislyue (sqjbqukhts ) View more	-	01 Apr 2014
				Mirabegron 50 mg/day