Delving into the Latest Updates on Solifenacin Succinate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Solifenacin succinate (JAN/USAN/INN)

+ [5]

Target

M3 receptor

Mechanism

M3 receptor agonists(Muscarinic acetylcholine receptor M3 agonists)

Therapeutic Areas

Urogenital Diseases

Active Indication

Neurogenic detrusor overactivityUrinary Bladder, OveractivePollakisuria+ [2]

Inactive Indication

Lower Urinary Tract SymptomsProstatic HyperplasiaUrinary Bladder Neck Obstruction+ [1]

Originator Organization

Astellas Pharma, Inc.

Active Organization

Astellas Pharma Australia Pty Ltd.Astellas Pharma US, Inc.

Astellas Pharma, Inc.

+ [1]

Inactive Organization

Astellas Pharma Europe Ltd.

Drug Highest PhaseApproved

First Approval Date

NL (08 Jun 2004),

Overactive bladder syndrome

RegulationPriority Review (CN)

Login to view timeline

Structure/Sequence

Molecular FormulaC27H32N2O6

InChIKeyRXZMMZZRUPYENV-VROPFNGYSA-N

CAS Registry242478-38-2

The aim of this study is to give children with dry OAB: (1) Standard behavioral therapy combined with classical anticholinergic drugs (Solinaxine), or (2) standard behavioral therapy combined with short-term high-dose exogenous vitamin D supplementation are used to compare the outcomes of lower urinary tract symptoms in children with dry OAB during follow-up. To provide more robust supporting evidence for the broader promotion of short-term high-dose exogenous vitamin D supplements in combination with standard behavioral therapy as an effective treatment for dry OAB treatment in children.

Start Date01 Dec 2024

Sponsor / Collaborator

Children’S Hospital Of Chongqing Medical University

[+2]

CTRI/2024/09/073950

/ Not yet recruitingNot ApplicableIIT

Effect of oral flavoxate on postoperative catheter related bladder dysfunction in adult males undergoing transurethral resection of bladder tumors- A randomized controlled trial vs solifenacin and placebo - Nil

Start Date17 Sep 2024

Sponsor / Collaborator-

100 Clinical Results associated with Solifenacin Succinate

Login to view more data

100 Translational Medicine associated with Solifenacin Succinate

Login to view more data

100 Patents (Medical) associated with Solifenacin Succinate

Login to view more data

161

Literatures (Medical) associated with Solifenacin Succinate

01 Nov 2024·BMJ Medicine

Risk of dementia associated with anticholinergic drugs for overactive bladder in adults aged ≥55 years: nested case-control study

Article

Author: Avery, Anthony J ; Iyen, Barbara ; Bell, Brian Gregory ; Ashcroft, Darren M ; Bishara, Delia ; Orrell, Martin William ; Coupland, Carol ; Dening, Tom

ObjectiveTo investigate whether different anticholinergic drug treatments for overactive bladder have differential risks for incident dementia, in a large representative population of older adults in England.DesignNested case-control study.SettingGeneral practices in England providing data to the Clinical Practice Research Datalink (CPRD) GOLD database, with linked patient admission records from secondary care (Hospital Episode Statistics), 1 January 2006 and 16 February 2022Participants170 742 patients aged ≥55 years, with a first reported diagnosis of dementia during the study period, matched by age, sex, and general practice with 804 385 individuals without dementia (controls).InterventionsCumulative drug use (defined using total standardised daily dose) of different anticholinergic drugs used for the treatment of an overactive bladder, and a non-anticholinergic drug, mirabegron, in the period 3-16 years before a diagnosis of dementia (or equivalent date in matched controls).Main outcome measuresOdds ratios for onset of dementia associated with the different anticholinergic drugs used for the treatment of an overactive bladder, adjusted for sociodemographic characteristics, clinical comorbidities, and use of other anticholinergic drug treatments.ResultsThe study population comprised 62.6% women, and median age was 83 (interquartile range 77-87) years. 15 418 (9.0%) patients with dementia and 63 369 (7.9%) controls without dementia had used anticholinergic drugs for the treatment of an overactive bladder in the 3-16 years before diagnosis (or equivalent date for controls). The adjusted odds ratio for dementia associated with the use of any anticholinergic drug used to treat an overactive bladder was 1.18 (95% confidence interval (CI) 1.16 to 1.20), and was higher in men (1.22, 1.18 to 1.26) than women (1.16, 1.13 to 1.19). The risk of dementia was substantially increased with the use of oxybutynin hydrochloride (adjusted odds ratio 1.31, 95% CI 1.21 to 1.42 and 1.28, 1.15 to 1.43 for use of 366-1095 and >1095 total standardised daily doses, respectively), solifenacin succinate (1.18, 1.09 to 1.27 and 1.29, 1.19 to 1.39), and tolterodine tartrate (1.27, 1.19 to 1.37 and 1.25, 1.17 to 1.34). No significant increases in the risk of dementia associated with darifenacin, fesoterodine fumarate, flavoxate hydrochloride, propiverine hydrochloride, and trospium chloride were found. The association between mirabegron, a non-anticholinergic drug, and dementia was variable across the dose categories and might be caused by previous use of anticholinergic drugs for the treatment of an overactive bladder in these individuals.ConclusionsOf the different anticholinergic drugs used to treat an overactive bladder, oxybutynin hydrochloride, solifenacin succinate, and tolterodine tartrate were found to be most strongly associated with the risk of dementia in older adults. This finding emphasises the need for clinicians to take into account the possible long term risks and consequences of the available treatment options for an overactive bladder in older adults, and to consider prescribing alternative treatments that might be associated with a lower risk of dementia.

01 Oct 2024·Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy

Diaryl pyrrolone fluorescent probing strategy for Mirabegron determination through condensation with ninhydrin and phenylacetaldehyde: Application to dosage forms, human urine and plasma

Article

Author: Abdelshakour, Mohamed A ; Badr El-Din, Khalid M ; Ahmed, Ahmed S ; Oraby, Mohamed ; Derayea, Sayed M

Mirabegron (MRB) is a β₃-adrenoceptor agonist used for managing overactive bladder syndrome. A cost-effective, environmentally friendly, and highly sensitive spectrofluorimetric method was suggested to serve the purpose of quantifying MRB in its pure state, pharmaceutical tablets, spiked human plasma and urine, and testing content uniformity. In the present study, ninhydrin and phenylacetaldehyde react with the amino group moiety of MRB in Teorell-Stenhagen buffer (pH 7.5) to generate a strongly fluorescent diaryl pyrrolone compound that emits fluorescence at a wavelength of 477 nm upon excitation at 385 nm. The obtained calibration curve showed a linear relationship with a high correlation coefficient (r = 0.9997) in the concentration range of 0.25 to 5.0 µg mL^-1. Limits of detection (LOD) and quantitation (LOQ) were 0.082 and 0.248 µg mL^-1 respectively. The procedure was verified in accordance with the ICH guidelines. The suggested approach could be utilized for the selective analysis of MRB in its pharmaceuticals, either containing a single drug or co-formulated with solifenacin succinate. The greenness of the suggested method was confirmed using different green analytical metrics.

01 Oct 2024·Heliyon

Disproportionality analysis of drug-induced dry mouth using data from the United States food and drug administration adverse event reporting system database

Article

Author: Xu, Dan ; Wu, Meng ; Zhu, Hong

BackgroundDrug-induced dry mouth is an adverse reaction that can significantly affect the quality of life and mental state of patients. In this study, we aimed to identify the most common drugs associated with dry mouth using data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.MethodsWe accessed data from the FAERS database between the first quarter of 2004 and the first quarter of 2024. The Medical Dictionary for Regulatory Activities was used to identify reports of dry mouth, and disproportionality analyses (reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker) were performed to examine the risk signals for dry mouth and its causative drugs.ResultsA total of 75,899 adverse event reports were related to dry mouth. Tiotropium bromide monohydrate (2080 cases) was associated with the majority of dry mouth cases. Disproportionality analysis revealed that the top five drugs with the highest reporting odds ratio (ROR) were darifenacin, solifenacin succinate, fesoterodine fumarate, tolterodine tartrate, and niraparib. Moreover, eight of the top 19 drugs that caused dry mouth were not identified as having major side effects in the package inserts.ConclusionTiotropium bromide monohydrate was the most frequently reported drug for dry mouth, whereas darifenacin had the highest ROR. Collectively, our findings emphasize the necessity for improved recognition and management of drug-induced dry mouth, particularly for medications not adequately flagged for this side effect in their labels.

7

News (Medical) associated with Solifenacin Succinate

04 Dec 2024

·www.drugs.com

Overactive Bladder Diagnoses Increased After Guideline Publication

WEDNESDAY, Dec. 4, 2024 -- An increase in overactive bladder (OAB) diagnoses was seen following publication of the first OAB guideline, and the rate of third-line therapy procedures also increased, according to a study published online Nov. 19 in Neurourology & Urodynamics . Hodan Mohamud, from the University of Toronto, and colleagues conducted a retrospective cohort study to examine trends in therapy utilization before and after the 2014 American Urological Association/Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction OAB guideline amendment and publication of a clinical care pathway in 2016. Patterns of care were assessed from 2013 to 2018. The study included 1,825,782 patients (mean age, 61.1 ± 16.7 years). From 2013 to 2017, the researchers found a 369 percent increase in the number of new OAB diagnoses. Nineteen percent of patients were treated with oral and/or third-line therapies during the six-year study period. The number of oral medications prescribed peaked in 2016, then decreased 17 percent by 2018. The two most prescribed oral medications in 2013 were oxybutynin and solifenacin (46.0 and 31.8 percent, respectively). Mirabegron surpassed solifenacin by 2018 (18.5 versus 16.5 percent), while oxybutynin still accounted for most prescriptions (55 percent). Patients older than 65 years of age filled 80 percent of all initial mirabegron prescriptions. From 2013 to 2018, the rate of third-line therapy procedures nearly doubled (nine to 17 per 1,000 OAB patients). "These trends suggest that OAB therapy guidelines and clinical practice pathways may influence treatment patterns," the authors write. One author disclosed ties to the pharmaceutical industry.

Clinical Result

26 Jun 2023

·www.adamed.com

Adamed Launches New Polish Drug to Effectively Support Patients with Urological Diseases

Adamed Pharma is launching its latest combination drug containing an innovative composition of solifenacin and tamsulosin, which is an important addition to the therapies available in the field of pharmacotherapy for urinary tract complaints in men caused by benign prostatic hyperplasia. Adamed Pharma has spent more than five years developing and implementing the drug, which responds to the needs of patients around the world. Adamed Pharma began development of the combination product (modified-release tablets containing solifenacin succinate + tamsulosin hydrochloride) in July 2018. It was an in-depth analysis of patient needs for urological diseases that influenced the decision to develop the drug for such a broad patient population. Indeed, benign prostatic hyperplasia is often a very important life problem for men, negatively affecting both professional and private life. Given the widespread epidemiology of prostatic hyperplasia diseases, the composition of solifenacin with tamsulosin in oral tablet form is the subject of an international patent application of Adamed Pharma (WO2022117594). Benign Prostatic Hyperplasia (BPH) is a non-cancerous enlargement of the prostate, the small gland that surrounds the male urethra. Benign prostatic hyperplasia is among the most common urological diseases in men and is age-related. According to demographic forecasts by Statistics Poland (GUS), in Poland in 2050, the share of people over the age of 65 will be as high as 32.7%[i], so in the not-too-distant future, many men will live to an age when they develop symptoms of BPH. More than 70% of men over the age of 40 are affected by lower urinary tract complaints.[ii] The latest analysis – conducted as part of the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 – covered 204 countries in the years 2000-2019. It was revealed that there were 94.0 million cases of benign prostatic hyperplasia worldwide in 2019, up from 51.1 million cases in 2000 (70.5% increase in incidence). In Eastern Europe, by contrast, the percentage change in the incidence of BPH was 19.3%, with 49.9% in Poland.[iii]. “We are proud of the results we have achieved in the development of our new value-added product and the process of its launch in the global market. Thanks to the work of the Adamed Research Team and the commitment of our partners, we are introducing a therapy which has a significant impact on the lives and health of patients around the world,” says Sylwia Berdzik-Kalarus, Member of the Management Board of Adamed Pharma S.A., Director of Commercial Affairsand Business Development. The partner involved financially in the development and implementation of this Adamed product is Adalvo, a leading B2B pharmaceutical company in Europe. “Adamed’s mission is to respond to the key challenges of contemporary medicine. As a company founded and still run by doctors, Adamed has always put the well-being of patients first. That’s why we appreciate the cooperation between Adamed and Adalvo, which is based on deep understanding of patients, their needs and expectations,” she adds. Adamed Pharma’s R&D teams continue their R&D efforts to be able to provide patients with new innovative therapies in the future. More than 50 development projects are currently under way at various stages. [i] Polish Agency for Enterprise Development (PARP): Aging of the Population – A Challenge for the Labour Market, Activation of 50+ Employees; https://www.parp.gov.pl/storage/publications/pdf/Starzenie_sie_spoleczenstw.pdf [ii] Coyne K.S., Sexton C.C., Thompson C.L. et al.: The prevalence of lower urinary tract symptoms (LUTS) in the USA, the UK and Sweden: results from the Epidemiology of LUTS (EpiLUTS) study. Bju International. 2009;104(3):352–360 [iii] Awedew A.F., Han H., Abbasi B. et al.: The global, regional, and national burden of benign prostatic hyperplasia in 204 countries and territories from 2000 to 2019: a systematic analysis for the Global Burden of Disease Study 2019, The Lancet Healthy Longevity, Volume 3, Issue 11, 2022, Pages e754-e776, ISSN 2666-7568, https://doi-org.libproxy1.nus.edu.sg/10.1016/S2666-7568(22)00213-6

Drug Approval

05 Dec 2022

·www.businesswire.com

$4.2 Billion Overactive Bladder Treatment (OAB) Markets - Global Forecasts to 2027: Growing R&D Investments and the Launch of Novel Therapies in the Coming Years - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Overactive Bladder Treatment (OAB) Market by Drug type ( Anticholinergic (Solifenacin, Oxybutynin, Tolterodine, Darifenacin), Mirabegron), Botox, Neuromodulation, Disease Type (Idopathic OAB and Neurogenic OAB) and Region - Global Forecasts to 2027" report has been added to ResearchAndMarkets.com's offering. The global overactive bladder treatment market is projected to reach USD 4.2 billion by 2027 from USD 3.5 billion in 2022, at a CAGR of 3.6% Rising prevalence of overactive bladder across the globe coupled with rising awareness about treatment options available is driving the growth of the market. Additionally, use of neuromodulation techniques for the treatment of OAB is further expected to have a significant positive impact. The adoption of novel treatments and the launch of new drugs for OAB treatment are also likely to support market growth in the coming years. Mirabegron segment dominates the overactive bladder (OAB) treatment market in 2021. Based on type, the overactive bladder treatment market is segmented into anticholinergics, mirabegron, BOTOX, neuromodulation, and other treatments. Mirabegron held a dominant share of the market in 2021, owing to the lesser side-effects associated with this drug compared to other drug classes available in the market. Furthermore, neuromodulation segment is expected to grow at faster pace owing to launch of new SNM & PTNS for OAB in market. The idiopathic overactive bladder segment will witness the highest growth in overactive bladder treatment market during the forecast period. Based on disease type, the overactive bladder treatment market is segmented into idiopathic overactive bladder and neurogenic overactive bladder. The idiopathic overactive bladder segment accounted for a larger market share due to the higher prevalence of idiopathic overactive bladder disorders and increased use of drugs for the treatment. North America held dominant share in 2021. In 2021, North America accounted for the major share in the OAB treatment market. North America holds majority of the key market players leading to maturity of OAB treatment market in this region. Furthermore, favorable reimbursement policies in US is one of the leading factor projecting market growth in North America. Competitive landscape The prominent players in this market are Astellas Pharma Inc. (Japan), Teva Pharmaceutical Industries Ltd. (Israel), Pfizer Inc. (US), Medtronic Plc (Ireland), AbbVie Inc. (US), Viatris Inc. (US), Hisamitsu Pharmaceutical Co., Inc. (Japan), Johnson & Johnson Services, Inc. (US), and Endo Pharmaceuticals Inc. (Ireland). Market Dynamics Market Drivers Rising Prevalence of Overactive Bladder Syndrome Rapidly Aging Population and Subsequent Rise in Incidence of Diseases Characterized by Oab Development and Use of Innovative Intravesical Therapies Growing R&D Investments and the Launch of Novel Therapies in the Coming Years Market Restraints Frequent Product Recalls Increased Side-Effects of Anticholinergic Drugs Market Opportunities Novel Treatments, Robust Pipelines, and Patent Cliff of Certain Drugs Market Challenges Social Stigma and Lack of Awareness About OAB Companies mentioned: Abbvie Inc Ajanta Pharma Altherx Pharmaceuticals Amneal Pharmaceuticals LLC Apotex Inc Astellas Pharma Inc Bayer Ag Endo Pharmaceuticals Inc Glenmark Granules India Limited Hisamitsu Pharmaceutical Co Inc Hugel, Inc Intas Pharmaceuticals Ltd Johnson & Johnson Services, Inc Laborie Lupin Macleods Pharmaceuticals Ltd Medtronic Medytox Pfizer Inc Sun Pharmaceutical Industries Ltd Taiho Pharmaceutical Co Ltd Teva Pharmaceutical Industries Ltd Urovant Sciences Viatris Inc For more information about this report visit https://www.researchandmarkets.com/r/2n1a4y About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

100 Deals associated with Solifenacin Succinate

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D01269	Solifenacin Succinate	G04BD08	DB01591

R&D Status

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Neurogenic detrusor overactivity	US	Astellas Pharma US, Inc.	26 May 2020
Urinary Bladder, Overactive	JP	Astellas Pharma, Inc.	20 Apr 2006
Pollakisuria	US	Astellas Pharma US, Inc.	19 Nov 2004
Urinary Incontinence, Urge	US	Astellas Pharma US, Inc.	19 Nov 2004
Overactive bladder syndrome	NL	Astellas Pharma Europe BV	08 Jun 2004

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03149809 (BOSS PD, CTgov)	Phase 3	Urinary Bladder, Overactive \| Parkinson Disease	77	Pelvic floor muscle exercise-based behavioral therapy (Behavioral Therapy)	syxpyhwuyz(rpwsickpra) = pqlewzwtty hnxjucjuyl (zgjzjudkpr, quuyudhknp - syqblrrrga) View more	-	24 Sep 2024
				solifenacin (Drug Therapy)	syxpyhwuyz(rpwsickpra) = bjgcexqmlb hnxjucjuyl (zgjzjudkpr, aafjcyjzwu - dnlzzfvoff) View more
NCT01565694 (CTgov)	Phase 3	Neurogenic detrusor overactivity	76	Solifenacin succinate	rovrwsfmkz(bqgnizffwm) = nsnyjjmvir qarqnhjclq (bqyacrfjpz, pjtxefbjdx - jmafiaepyh) View more	-	06 May 2019
NCT02549196 (CPC-12, CTgov)	Phase 2	Dystocia \| Dementia due to Alzheimer's disease (disorder)	28	Donepezil+Solifenacin (Cohort 1)	mhbdtimkyf(zlqmlxtgoe) = vvjulcjwfv aevrivrqvw (payuglkcvu, cpqukkupzf - ffxudragre) View more	-	05 Mar 2019
				Donepezil+Solifenacin (Cohort 2)	mhbdtimkyf(zlqmlxtgoe) = mkjfemslvd aevrivrqvw (payuglkcvu, bjfnezauzz - anfawdogpq) View more
NCT02294396 (CTgov)	Phase 4	Urinary Bladder, Overactive	649	Mirabegron tablet+Solifenacin tablet (Mirabegron + Solifenacin)	kouwzdigjn(varxzsywej) = rugvlmmtuy ibhhppooie (wdpziqlwol, qatpzomtxe - middqovwjo) View more	-	24 Dec 2018
				Mirabegron tablet+Propiverine tablet (Mirabegron + Propiverine)	kouwzdigjn(varxzsywej) = mvzulelvdb ibhhppooie (wdpziqlwol, wuegcxjbks - utxopxgarc) View more
NCT02045862 (SYNERGY II, Pubmed \| Eur Urol)	Phase 3	Urinary Bladder, Overactive	1,829	Solifenacin succinate 5mg plus Mirabegron 50mg	truqqudnfz(hijvqtwhzl) = Overall, 856 patients (47%) experienced ≥1 TEAE. TEAE frequency was slightly higher in the combination group (596 patients, 49%; mirabegron 126 patients, 41%; solifenacin 134 patients, 44%). Serious TEAEs were reported by 67 patients (3.7%); one was considered possibly treatment-related (mirabegron group, atrial fibrillation). Dry mouth was the most common TEAE (combination 74 patients, 6.1%; solifenacin 18 patients, 5.9%; mirabegron 12 patients, 3.9%) obfunoucxn (uxwzehrhhb ) View more	-	01 Oct 2018
				Solifenacin succinate 5mg
NCT01981954 (CTgov)	Phase 3	Neurogenic detrusor overactivity	23	Solifenacin succinate	cphpgsnpub(kcrbbjplqz) = hnjawmtxkh xvbujhkpyh (ezkoglanzi, wgvcmuqwvq - jwdmkhzoth) View more	-	21 Jun 2018
NCT01972841 (SYNERGY, CTgov)	Phase 3	Urinary Bladder, Overactive	3,527	placebo (Placebo)	cpldbmoplv(rnnshtpsld) = btqzyihzna ojikpuwlhi (wpmnbdsqqq, xmxiscobef - xewbucfuhi) View more	-	12 Jun 2018
				Mirabegron (Mirabegron 25 mg)	cpldbmoplv(rnnshtpsld) = tckzqsegpv ojikpuwlhi (wpmnbdsqqq, pzqaqeqffb - nqqokghdcv) View more
NCT02045862 (SYNERGY II, CTgov)	Phase 3	Urinary Bladder, Overactive	1,829	Placebo to match solifenacin+Mirabegron (Mirabegron 50 mg)	vadrbifxqf(tugohiyjtd) = errsqteivx dqmoelxsdc (nyqgorbbii, wlgidltrib - ubsuztzvft) View more	-	06 Jun 2018
				Placebo to match mirabegron+Solifenacin succinate (Solifenacin 5 mg)	vadrbifxqf(tugohiyjtd) = hskfbnpplr dqmoelxsdc (nyqgorbbii, wlwzegkpxu - exdglncknf) View more
NCT01486706 (Pubmed \| Low Urin Tract Symptoms)	Phase 2/3	Urinary Bladder, Overactive	94	Placebo	qhengseekd(vnxgwdhjfh): AMD = -1.179 (95% CI, -1.98 to -0.38) View more	Positive	01 May 2018
				Gabapentin
NCT01745094 (CTgov)	Phase 4	Urinary Bladder, Overactive	223	Mirabegron+Solifenacin (Solifenacin 2.5 mg + Mirabegron 25 mg)	exzjivrxhx(expsptypaq) = fwwltyutid fvqwxkcnxo (nmbmqogjkl, jkzyksuovn - scyiayihbl) View more	-	28 Feb 2018
				Mirabegron+Solifenacin (Solifenacin 2.5 mg + Mirabegron 50 mg)	exzjivrxhx(expsptypaq) = pnxigxkoiz fvqwxkcnxo (nmbmqogjkl, iiptrmwtva - lyesjjuxbf) View more