Delving into the Latest Updates on Solifenacin Succinate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Solifenacin succinate (JAN/USAN/INN), HGP-1103, YM-67905

+ [5]

Target

M3 receptor

Action

agonists

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 Europe BVAstellas Pharma US, Inc.

+ [1]

Inactive Organization

Astellas Pharma Europe Ltd.

Drug Highest PhaseApproved

First Approval Date

United Kingdom (08 Jun 2004),

Overactive bladder syndrome

Regulation-

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Structure/Sequence

Molecular FormulaC27H32N2O6

InChIKeyRXZMMZZRUPYENV-VROPFNGYSA-N

CAS Registry242478-38-2

A retrospective chart review was conducted from 2015 to 2023, including consecutive paediatric patients receiving Mirabegron (25/50 mg) with an anticholinergic agent (solifenacin 16, tolterodine 7, oxybutynin 7, trospium 1). MAC was started where previous therapy had failed to control bladder pressures. The study cohort had a minimum of 2 years of videourodynamics (VUD) follow-up (2-7 years) and 3.5 years of symptomatic follow-up (2-7 years). All patients used CIC. Efficacy was determined from VUD data, symptom reports, and adverse events (AEs) with upper tract status. Statistical analysis used median values, Friedman's two-way analysis of variance by ranks and Chi-squared testing (p < 0.05).

RESULTS:

The analysis included 31 children (median age at start: 8 years, range: 4-15 years; 12 females) with neurogenic bladder due to myelomeningocele (17), closed spinal dysraphism (11), or spinal cord injury/tumour (3). A minimum of 8 weeks post-MAC therapy, significant improvements were observed in VUD parameters of: bladder capacity, compliance, and maximum detrusor pressure. These improvements were sustained at final VUD follow-up (median 33 months) in 21 patients (Summary Table). However, 9 patients who showed initial VUD improvement at median 5 months lost the effect by median 27 months, with 4 non-adherent patients and 5 with lower initial bladder compliance. Initial symptom improvement occurred in 25 patients, sustained for a median of 43 months (range: 23-85) in 19 patients. Adverse events were minimal (constipation, fatigue, and UTI reported in one patient each). No significant changes in blood pressure or upper tract status were observed.

CONCLUSION:

MAC combination effectively manages paediatric neurogenic bladder resistant to AC and BTX therapy. The VUD benefits (present in 77.8 %) and symptom benefits (present in 61 %) are maintained and ongoing for a significant period (median 33 and 43 months respectively) when commenced before significant loss of compliance. MAC presents a promising long-term treatment option for the paediatric neurogenic bladder.

01 Apr 2025·Urogynecology (Philadelphia, Pa.)

Trends in Medicare Coverage of Overactive Bladder Medications in the United States

Article

Author: Wallace, Megan B. ; Gaddam, Neha G. ; Dieter, Alexis A.

Importance:

Strong evidence demonstrates long-term cognitive decline associated with anticholinergics. While prevalent among older populations, medical management of overactive bladder (OAB) is dictated by insurance coverage rather than medical provider and patient preferences.

Objective:

The aim of this study was to assess Medicare insurance plan coverage for select OAB medications and evaluate coverage of preferred medications to medications with a greater risk of cognitive dysfunction.

Study Design:

This cross-sectional study analyzed formularies and coverage tiers across 6 U.S. insurers for the following OAB medications: oxybutynin instant-release (IR) 5 mg, oxybutynin extended-release (ER) 5 mg, tolterodine IR 1 mg, tolterodine ER 2 mg, fesoterodine ER 4 mg, darifenacin 7.5 mg, solifenacin 5 mg, trospium IR 20 mg, trospium ER 60 mg, mirabegron 25 mg, and vibegron 75 mg. Coverage was compared between nonpreferred (oxybutynin, tolterodine, fesoterodine, darifenacin, solifenacin) and preferred medications (trospium, mirabegron, vibegron). Coverage scores, a weighted distribution based on coverage tier frequency relative to the number of plans investigated, were generated with a lower score indicating better coverage (range, 0.2–1.0).

Results:

One thousand six hundred nineteen insurance plans representing an estimated 47% of the market share were evaluated. Oxybutynin IR had the best coverage score across insurers (0.4), whereas trospium ER had the worst (0.89). Preferred medications had worse coverage versus nonpreferred medications (P < 0.001). Centene had the best overall coverage and lowest initiation cost, whereas Aetna/CVS had the best coverage and initiation cost for preferred medications.

Conclusions:

Beta-3 agonists had worse coverage across insurers nationwide. Current trends in Medicare coverage reveal a need for improved coverage of preferred OAB medications for an aging population already at risk of cognitive dysfunction.

01 Feb 2025·BMJ medicine

Bladder drugs and risk of dementia: Danish nationwide active comparator study

Article

Author: Janbek, Janet ; Waldemar, Gunhild ; Gasse, Christiane ; Meaidi, Amani ; Pourhadi, Nelsan ; Jensen-Dahm, Christina ; Laursen, Thomas Munk

Objective:

To assess the association between cumulative use of anticholinergic bladder drugs and risk of all cause dementia compared with non-use and use of the β3 agonist bladder drug, mirabegron.

Design:

Danish nationwide active comparator study.

Setting:

National Danish registries, 1 January 2000 to 31 December 2022.

Participants:

1 29 254 individuals with dementia were matched by age and sex to 646 270 controls without dementia, identified from a cohort of 2.26 million individuals aged 60-75 years between 2000 and 2022 with no previous dementia. Two separate nested case-control populations were studied: the general population and an active comparator population of 58 242 new users of bladder drugs (2198 developed dementia and were matched to 10 990 controls). Information on medication use was based on filled prescriptions and defined daily doses.

Main outcome measures:

Conditional logistic regression provided incidence rate ratios for associations between anticholinergic bladder drugs and dementia compared with non-use and mirabegron use adjusted for educational level, cardiovascular disease, diabetes, hypertension, dyslipidaemia, and Charlson Comorbidity Index.

Results:

Compared with non-use, ever use of anticholinergic bladder drugs was associated with an increased risk of dementia, with an incidence rate ratio of 1.44 (95% confidence interval (CI) 1.40 to 1.48). The incidence rate ratio increased with increasing cumulative drug use, from 1.31 (95% CI 1.27 to 1.36) for 1-90 defined daily doses to 1.68 (1.59 to 1.76) for >365 defined daily doses. Compared with non-use, all types of anticholinergic bladder drugs were associated with increased incidence rate ratios for dementia: tolterodine 1.43 (95% CI 1.38 to 1.49), solifenacin 1.37 (1.29 to 1.46), trospium 1.52 (1.37 to 1.67), and fesoterodine 1.48 (1.26 to 1.74). The increased risk of dementia with use of anticholinergic bladder drugs was not seen when compared directly with the use of the β3 agonist mirabegron (incidence rate ratio 0.82, 95% CI 0.74 to 0.92), irrespective of the type of anticholinergic drug.

Conclusions:

In this study, all types of anticholinergic bladder drugs were associated with an increased risk of dementia compared with non-use, but not when applying the active comparator of the β3 agonist bladder drug mirabegron. These findings highlight the relevance of using an active comparator. Future research should evaluate the risk of cognitive impairment and dementia for both types of bladder drugs.

8

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

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KEGG	Wiki	ATC	Drug Bank
D01269	Solifenacin Succinate	G04BD08	DB01591

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Neurogenic detrusor overactivity	United States	Astellas Pharma US, Inc.	26 May 2020
Urinary Bladder, Overactive	Japan	Astellas Pharma, Inc.	20 Apr 2006
Pollakisuria	United States	Astellas Pharma US, Inc.	19 Nov 2004
Urinary Incontinence, Urge	United States	Astellas Pharma US, Inc.	19 Nov 2004
Overactive bladder syndrome	Austria	Astellas Pharma Europe BV	08 Jun 2004
Overactive bladder syndrome	Belgium	Astellas Pharma Europe BV	08 Jun 2004
Overactive bladder syndrome	Cyprus	Astellas Pharma Europe BV	08 Jun 2004
Overactive bladder syndrome	Czechia	Astellas Pharma Europe BV	08 Jun 2004
Overactive bladder syndrome	Denmark	Astellas Pharma Europe BV	08 Jun 2004
Overactive bladder syndrome	Finland	Astellas Pharma Europe BV	08 Jun 2004
Overactive bladder syndrome	France	Astellas Pharma Europe BV	08 Jun 2004
Overactive bladder syndrome	Germany	Astellas Pharma Europe BV	08 Jun 2004
Overactive bladder syndrome	Greece	Astellas Pharma Europe BV	08 Jun 2004
Overactive bladder syndrome	Hungary	Astellas Pharma Europe BV	08 Jun 2004
Overactive bladder syndrome	Iceland	Astellas Pharma Europe BV	08 Jun 2004
Overactive bladder syndrome	Ireland	Astellas Pharma Europe BV	08 Jun 2004
Overactive bladder syndrome	Italy	Astellas Pharma Europe BV	08 Jun 2004
Overactive bladder syndrome	Liechtenstein	Astellas Pharma Europe BV	08 Jun 2004
Overactive bladder syndrome	Lithuania	Astellas Pharma Europe BV	08 Jun 2004
Overactive bladder syndrome	Luxembourg	Astellas Pharma Europe BV	08 Jun 2004

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Urinary urgency	Phase 3	Belgium	Astellas Pharma, Inc.	01 Apr 2004
Urinary urgency	Phase 3	Czechia	Astellas Pharma, Inc.	01 Apr 2004
Urinary urgency	Phase 3	Egypt	Astellas Pharma, Inc.	01 Apr 2004
Urinary urgency	Phase 3	France	Astellas Pharma, Inc.	01 Apr 2004
Urinary urgency	Phase 3	Germany	Astellas Pharma, Inc.	01 Apr 2004
Urinary urgency	Phase 3	Greece	Astellas Pharma, Inc.	01 Apr 2004
Urinary urgency	Phase 3	Hungary	Astellas Pharma, Inc.	01 Apr 2004
Urinary urgency	Phase 3	Italy	Astellas Pharma, Inc.	01 Apr 2004
Urinary urgency	Phase 3	Poland	Astellas Pharma, Inc.	01 Apr 2004
Urinary urgency	Phase 3	Portugal	Astellas Pharma, Inc.	01 Apr 2004

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Clinical Result

Indication

Phase

Evaluation

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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)	fjgpxuoijv(vsympogauy) = xjyikugdam clpwsbbpln (ukdvpbwvin, 2.0) View more	-	24 Sep 2024
				solifenacin (Drug Therapy)	fjgpxuoijv(vsympogauy) = dgxbubiexc clpwsbbpln (ukdvpbwvin, 2.4) View more
NCT04090190 (CTgov)	Phase 4	Urinary Incontinence \| Urinary urgency \| Inflammation	20	Oxybutynin+Tolterodine+Trospium+Solifenacin+Fesoterodine	dizzdjzsqn(mwfieqnzfs) = kgisqlsymh ovbfgfjdxk (pkpedkcqgm, yxuzyryeed - jrfspwyxzt) View more	-	03 Oct 2022
NCT01981954 \| NCT01565694 (Pubmed \| J Pediatr Urol)	Phase 3	Neurogenic detrusor overactivity	-	Solifenacin oral suspension	ymnvxujfpb(tcjjiafabw) = fjsmcoszti lvhyrbtttt (ifenfxvtgy )	-	01 Apr 2020
NCT01565694 (CTgov)	Phase 3	Neurogenic detrusor overactivity	76	Solifenacin succinate	vegebyjwmc(mgplllytyd) = uphenadxvt zjseipcfxb (vezzfnfqnz, 107.7) View more	-	06 May 2019
NCT02549196 (CPC-12, CTgov)	Phase 2	Dystocia \| Dementia due to Alzheimer's disease (disorder)	28	Donepezil+Solifenacin (Cohort 1)	dutfuztczy = giosqothky jpjildsmxr (lmoihuflqr, blsddtugpd - wtvraarlsq) View more	-	05 Mar 2019
				Donepezil+Solifenacin (Cohort 2)	dutfuztczy = xnqvetwabs jpjildsmxr (lmoihuflqr, szxhzhxzql - ixlgtczbls) View more
NCT02294396 (CTgov)	Phase 4	Urinary Bladder, Overactive	649	Mirabegron tablet+Solifenacin tablet (Mirabegron + Solifenacin)	fxzxncntba = ckepcojftc nyqroqazho (laqxgkkkyu, xhufglsqvp - ijllnynpeu) View more	-	24 Dec 2018
				Mirabegron tablet+Propiverine tablet (Mirabegron + Propiverine)	fxzxncntba = ueyiexmlff nyqroqazho (laqxgkkkyu, mmohdelaud - bikflzzycm) View more
NCT01981954 (CTgov)	Phase 3	Neurogenic detrusor overactivity	23	Solifenacin succinate	zkantwzbsh(jzmueebura) = cwvinxqiti qfvduulzvy (hsqlbnzccq, 35.9) View more	-	21 Jun 2018
NCT01972841 (SYNERGY, CTgov)	Phase 3	Urinary Bladder, Overactive	3,527	placebo (Placebo)	gdkotbwqkm(fbifuqlhbj) = akiuvkyfjk rxervrbnfb (thyxgsznyh, 0.10) View more	-	12 Jun 2018
				Mirabegron (Mirabegron 25 mg)	gdkotbwqkm(fbifuqlhbj) = tigsxbikym rxervrbnfb (thyxgsznyh, 0.10) View more
NCT02045862 (SYNERGY II, CTgov)	Phase 3	Urinary Bladder, Overactive	1,829	Placebo to match solifenacin+Mirabegron (Mirabegron 50 mg)	krxlwzugxy = saxmqenyff mlyzcvwded (malimvhkwq, ehgkbxyevj - izlrsyjgxc) View more	-	06 Jun 2018
				Placebo to match mirabegron+Solifenacin succinate (Solifenacin 5 mg)	krxlwzugxy = tldoakgrrm mlyzcvwded (malimvhkwq, eozxapcvmh - umruvrjqmf) View more
NCT01486706 (Pubmed \| Low Urin Tract Symptoms)	Phase 2/3	Urinary Bladder, Overactive	94	Placebo	cquxukqoyf(lnirtluexq): AMD = -1.179 (95% CI, -1.98 to -0.38) View more	Positive	01 May 2018
				Gabapentin