[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy and safety of fesoterodine fumarate extended-release tablets in patients with overactive bladder

评价富马酸非索罗定缓释片用于膀胱过度活动症患者的有效性和安全性

[Translation]

To evaluate the efficacy and safety of fesoterodine fumarate extended-release tablets in patients with overactive bladder

Start Date25 Aug 2023

Sponsor / Collaborator

Cisen Pharmaceutical Ltd.

[+1]

CTR20220830 / RecruitingNot Applicable

评估受试制剂富马酸非索罗定缓释片（规格：8 mg）与参比制剂（Toviaz®）（规格：8 mg）在中国健康受试者中空腹和餐后状态下的单中心、开放、随机、单剂量、两周期、双交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, two-period, double-crossover bioequivalence study to evaluate the bioequivalence of the test formulation, fesoterodine fumarate extended-release tablets (strength: 8 mg), and the reference formulation (Toviaz®) (strength: 8 mg) in healthy Chinese subjects under fasting and fed conditions

主要研究目的以江苏万邦生化医药集团有限责任公司研制的富马酸非索罗定缓释片（规格：8mg）为受试制剂，按生物等效性研究的有关规定，与Pfizer Europe MA EEIG持证、Pfizer Manufacturing Deutschland GmbH生产的富马酸非索罗定缓释片（参比制剂，商品名：Toviaz®，规格：8 mg）对比在健康人体内的药代动力学特征，考察两制剂的人体生物等效性。次要研究目的考察富马酸非索罗定缓释片受试制剂（规格：8 mg）和参比制剂（商品名：Toviaz®，规格：8 mg）在健康受试者中的安全性。

[Translation]

Main research purpose Using fesoterodine fumarate sustained-release tablets (specification: 8 mg) developed by Jiangsu Wanbang Biochemical Pharmaceutical Group Co., Ltd. as the test preparation, according to the relevant provisions of bioequivalence studies, the pharmacokinetic characteristics in healthy humans were compared with fesoterodine fumarate sustained-release tablets (reference preparation, trade name: Toviaz®, specification: 8 mg) certified by Pfizer Europe MA EEIG and produced by Pfizer Manufacturing Deutschland GmbH, to investigate the bioequivalence of the two preparations in humans. Secondary research purpose Investigate the safety of fesoterodine fumarate sustained-release tablets (specification: 8 mg) and reference preparations (trade name: Toviaz®, specification: 8 mg) in healthy subjects.

Start Date20 Feb 2022

Sponsor / Collaborator

Jiangsu Wanbang Biopharmaceuticals Co., Ltd.

CTR20211953 / CompletedNot Applicable

评估富马酸非索罗定缓释片（规格：8 mg）受试制剂与参比制剂（Toviaz®）在健康成年受试者空腹和餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the test formulation of fesoterodine fumarate extended-release tablets (strength: 8 mg) and the reference formulation (Toviaz®) in healthy adult subjects under fasting and fed conditions

主要试验目的：研究空腹和餐后状态下单次口服受试制剂富马酸非索罗定缓释片（规格：8 mg，广州玻思韬控释药业有限公司生产）与参比制剂富马酸非索罗定缓释片（Toviaz®，规格：8 mg；Pfizer Europe MA EEIG持证、Pfizer Manufacturing Deutschland GmbH生产）在健康受试者体内的药代动力学特征，评价空腹和餐后状态单次口服两种制剂的生物等效性。次要试验目的：研究单次口服富马酸非索罗定缓释片（规格：8 mg）受试制剂和参比制剂（Toviaz®）在健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation fesoterodine fumarate extended-release tablets (specification: 8 mg, produced by Guangzhou Bositao Controlled Release Pharmaceutical Co., Ltd.) and the reference preparation fesoterodine fumarate extended-release tablets (Toviaz®, specification: 8 mg; certified by Pfizer Europe MA EEIG, produced by Pfizer Manufacturing Deutschland GmbH) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after a single oral administration in the fasting and fed state. Secondary purpose of the study is to study the safety of the test preparation fesoterodine fumarate extended-release tablets (specification: 8 mg) and the reference preparation (Toviaz®) in healthy subjects after a single oral administration.

Start Date11 Sep 2021

Sponsor / Collaborator

Cisen Pharmaceutical Ltd.

100 Clinical Results associated with Fesoterodine Fumarate

100 Translational Medicine associated with Fesoterodine Fumarate

100 Patents (Medical) associated with Fesoterodine Fumarate

313

Literatures (Medical) associated with Fesoterodine Fumarate

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

Objective:

To 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.

Design:

Nested case-control study.

Setting:

General 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 2022

Participants:

170 742 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).

Interventions:

Cumulative 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 measures:

Odds 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.

Results:

The 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.

Conclusions:

Of 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.

02 Oct 2024·Expert Opinion On Drug Safety

An update on the cognitive safety of antimuscarinics in the treatment of overactive bladder

Review

Author: Lee, Kyu-Sung ; Alghamdi, Musab M. ; Ko, Kwang Jin

INTRODUCTION:

Antimuscarinics are often the first-choice medications used to treat overactive bladder (OAB), a condition that increasingly affects the aging population. However, concerns regarding their potential impact on cognitive function have persisted for more than a decade.

AREAS COVERED:

This review was conducted to update the literature on the cognitive safety profiles of various antimuscarinics, integrating findings from both recent and earlier studies to present an updated and comprehensive analysis. A search of English-language publications, including electronic databases and gray literature, focused on the cognitive impacts of antimuscarinics, resulting in a review and assessment of diverse studies and their associated outcomes.

EXPERT OPINION:

Oxybutynin requires caution due to potential adverse effects, suggesting a need to consider alternative therapies. Darifenacin, while promising in preserving cognitive function, warrants further investigation for use in dementia patients. Fesoterodine has shown tolerance without cognitive decline in controlled trials. However, Tolterodine and Solifenacin present conflicting evidence regarding cognitive impairment and dementia risk, respectively, necessitating additional research to ascertain their safety profiles. Careful monitoring and treatment of patients taking these medications for cognitive impairment are essential. Further research, particularly in vulnerable populations, is crucial to establish cognitive safety profiles of various antimuscarinics and inform optimal OAB treatment strategies.

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

Background:

Drug-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.

Methods:

We 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.

Results:

A 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.

Conclusion:

Tiotropium 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.

News (Medical) associated with Fesoterodine Fumarate

08 Jul 2022

·www.biospace.com

Dr. Reddy's Laboratories Announces the Launch of Fesoterodine Fumarate Extended-Release Tablets in the U.S. Market

HYDERABAD, India &PRINCETON, N.J.--(BUSINESS WIRE)-- Dr. Reddy's Laboratories, Inc. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) announces the launch of Dr. Reddy’s Fesoterodine Fumarate Extended-Release Tablets, a therapeutic generic equivalent to Toviaz® (fesoterodine fumarate) Extended-Release Tablets in the U.S. market following the approval by the U.S. Food and Drug Administration (USFDA). The Toviaz® brand had U.S. sales of approximately $211 million MAT for the most recent twelve months ending in May 2022 according to IQVIA. Dr. Reddy’s Fesoterodine Fumarate Extended-Release Tablets are available in 4 mg and 8 mg Tablets, each in bottle count sizes of 30. Please click here to see the full prescribing information: . Toviaz is a trademark of Pfizer Inc. RDY-0622-424 About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2022. The company assumes no obligation to update any information contained herein.

Generic DrugBiosimilarAcquisition

29 Jun 2022

·www.prnewswire.com

Interstitial Cystitis Drugs Market Recorded 4.81% Y-O-Y Growth Rate in 2021| Evolving Opportunities with Perrigo Co. Plc & Pfizer Inc | Technavio

NEW YORK, June 29, 2022 /PRNewswire/ -- The Interstitial Cystitis Drugs Market report provides a detailed analysis of the competitive scenario, the pre-and post-COVID-19 impact on businesses, and the market growth across various regions. The interstitial cystitis drugs market size is expected to increase by USD 283.95 million, at a CAGR of 5.06% from 2020 to 2025. Technavio categorizes the interstitial cystitis drugs market as a part of the global pharmaceuticals market within the overall healthcare industry. Our research report has extensively covered external factors influencing the parent market growth potential in the coming years, which will determine the levels of growth of the interstitial cystitis drugs market during the forecast period. Technavio has announced its latest market research report titled Interstitial Cystitis Drugs Market by Type and Geography - Forecast and Analysis 2021-2025 For more highlights on the parent market analysis - Request a sample now! Market Dynamics Drivers: The high prevalence of interstitial cystitis is notably driving the interstitial cystitis drugs market growth Trends: Increasing awareness of interstitial cystitis is the key market trend driving the interstitial cystitis drugs market growth. Challenges: The major challenge impeding the interstitial cystitis drugs market growth is the lack of approved drugs. For detailed highlights on the market dynamics - Click Now! Segmentation Analysis By Type, the market is classified into oral therapy and intravesical therapy. The interstitial cystitis drugs market share growth by the oral therapy segment will be significant for revenue generation. Pentosan polysulfate sodium (ELMIRON) is the only approved oral medication to repair the lining of the bladder in people with interstitial cystitis (IC). ELMIRON builds and restores the protective coating of the bladder tissue. There are many off-label oral drugs in the interstitial cystitis drugs market that can reduce the signs and symptoms of the disease facilitating the growth of the segment during the forecast period. By Geography, the market is classified as North America, Europe, Asia, and ROW. 36% of the market's growth will originate from North America during the forecast period. The US is a key market for interstitial cystitis drugs in North America. However, the market growth rate in this region will be slower than the growth of the market in Asia and Europe. The increasing cases of interstitial cystitis and a rise in research funding will facilitate the interstitial cystitis drugs market growth in North America over the forecast period. Company Profiles The interstitial cystitis drugs market is fragmented and the vendors are deploying various organic and inorganic growth strategies to compete in the market. The interstitial cystitis drugs market report provides complete insights on key vendors including Astellas Pharma Inc., Bayer AG, Johnson and Johnson Inc., Novartis AG, Perrigo Co. Plc, Pfizer Inc., Seikagaku Corp., Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., and Viatris Inc. Key Offerings: Perrigo Co. Plc - The company offers pain and sleep aids such as Ibuprofen. Pfizer Inc. - The company offers an interstitial cystitis drug named Toviaz. Seikagaku Corp. - The company is developing the interstitial cystitis and bladder pain syndrome drug SI-722. Sun Pharmaceutical Industries Ltd. - The company offers interstitial cystitis drugs such as Cystopen capsules Teva Pharmaceutical Industries Ltd. The company offers interstitial cystitis drugs such as VESIcare (solifenacin succinate) Tablets. To know about all major vendor offerings - Grab a sample now! Get ready to achieve excellent business outcomes from this exclusive Interstitial Cystitis Drugs Market report by Technavio. The report will include highlights of the overall market which includes frequently asked questions such as - What are historical revenue figures and estimated revenue figures as well as CAGR during the forecast timeframe? What is the current trend taking place in the market space? Which are business tactics that will influence competitive scenarios along with defining the growth potential of the market? What are market drivers, restraints, and challenges impacting demand & growth of the market? Which regions & segments will garner massive revenue and emerge as market leaders in upcoming years? The competitive scenario provided in the Interstitial Cystitis Drugs Market report analyzes, evaluates, and positions companies based on various performance indicators. Some of the factors considered for this analysis include the financial performance of companies over the past few years, growth strategies, product innovations, new product launches, investments, growth in market share, etc. Don't wait, Make a strategic approach & boost your business goals with our Interstitial Cystitis Drugs Market Forecast Report - Buy Now! Related Reports: The uveitis drugs market share is expected to increase to USD 269.65 million from 2021 to 2026, and the market's growth momentum will accelerate at a CAGR of 5.9%. The vitiligo therapeutics market share is expected to increase to USD 341.35 million from 2021 to 2026, and the market's growth momentum will accelerate at a CAGR of 4.5%. Table of Content 1 Executive Summary 2 Market Landscape 2.1 Market ecosystem Exhibit 01: Parent market Exhibit 02: Market characteristics 2.2 Value chain analysis Exhibit 03: Value chain analysis: Pharmaceuticals 3 Market Sizing 3.1 Market definition Exhibit 04: Offerings of vendors included in the market definition 3.2 Market segment analysis Exhibit 05: Market segments 3.3 Market size 2020 3.4 Market outlook: Forecast for 2020 - 2025 Exhibit 06: Global - Market size and forecast 2020 - 2025 ($ million) Exhibit 07: Global market: Year-over-year growth 2020 - 2025 (%) 4 Five Forces Analysis 4.1 Five forces summary Exhibit 08: Five forces analysis 2020 & 2025 4.2 Bargaining power of buyers Exhibit 09: Bargaining power of buyers 4.3 Bargaining power of suppliers Exhibit 10: Bargaining power of suppliers 4.4 Threat of new entrants Exhibit 11: Threat of new entrants 4.5 Threat of substitutes Exhibit 12: Threat of substitutes 4.6 Threat of rivalry Exhibit 13: Threat of rivalry 4.7 Market condition Exhibit 14: Market condition - Five forces 2020 5 Market Segmentation by Type 5.1 Market segments Exhibit 15: Type - Market share 2020-2025 (%) 5.2 Comparison by Type Exhibit 16: Comparison by Type 5.3 Oral therapy - Market size and forecast 2020-2025 Exhibit 17: Oral therapy - Market size and forecast 2020-2025 ($ million) Exhibit 18: Oral therapy - Year-over-year growth 2020-2025 (%) 5.4 Intravesical therapy - Market size and forecast 2020-2025 Exhibit 19: Intravesical therapy - Market size and forecast 2020-2025 ($ million) Exhibit 20: Intravesical therapy - Year-over-year growth 2020-2025 (%) 5.5 Market opportunity by Type Exhibit 21: Market opportunity by Type 6 Customer landscape 7 Geographic Landscape 7.1 Geographic segmentation Exhibit 23: Market share by geography 2020-2025 (%) 7.2 Geographic comparison Exhibit 24: Geographic comparison 7.3 North America - Market size and forecast 2020-2025 Exhibit 25: North America - Market size and forecast 2020-2025 ($ million) Exhibit 26: North America - Year-over-year growth 2020-2025 (%) 7.4 Europe - Market size and forecast 2020-2025 Exhibit 27: Europe - Market size and forecast 2020-2025 ($ million) Exhibit 28: Europe - Year-over-year growth 2020-2025 (%) 7.5 Asia - Market size and forecast 2020-2025 Exhibit 29: Asia - Market size and forecast 2020-2025 ($ million) Exhibit 30: Asia - Year-over-year growth 2020-2025 (%) 7.6 ROW - Market size and forecast 2020-2025 Exhibit 31: ROW - Market size and forecast 2020-2025 ($ million) Exhibit 32: ROW - Year-over-year growth 2020-2025 (%) 7.7 Key leading countries Exhibit 33: Key leading countries 7.8 Market opportunity by geography Exhibit 34: Market opportunity by geography ($ million) 8 Drivers, Challenges, and Trends 8.1 Market drivers 8.2 Market challenges Exhibit 35: Impact of drivers and challenges 8.3 Market trends 9 Vendor Landscape 9.1 Overview 9.2 Vendor landscape Exhibit 36: Vendor landscape 9.3 Landscape disruption Exhibit 37: Landscape disruption Exhibit 38: Industry risks 10 Vendor Analysis 10.1 Vendors covered Exhibit 39: Vendors covered 10.2 Market positioning of vendors Exhibit 40: Market positioning of vendors 10.3 Astellas Pharma Inc. Exhibit 41: Astellas Pharma Inc. - Overview Exhibit 42: Astellas Pharma Inc. - Product and service Exhibit 43: Astellas Pharma Inc. - Key news Exhibit 44: Astellas Pharma Inc. - Key offerings 10.4 Bayer AG Exhibit 45: Bayer AG - Overview Exhibit 46: Bayer AG - Business segments Exhibit 47: Bayer AG - Key news Exhibit 48: Bayer AG - Key offerings Exhibit 49: Bayer AG - Segment focus 10.5 Johnson and Johnson Inc. Exhibit 50: Johnson and Johnson Inc. - Overview Exhibit 51: Johnson and Johnson Inc. - Business segments Exhibit 52: Johnson and Johnson Inc. - Key news Exhibit 53: Johnson and Johnson Inc. - Key offerings Exhibit 54: Johnson and Johnson Inc. - Segment focus 10.6 Novartis AG Exhibit 55: Novartis AG - Overview Exhibit 56: Novartis AG - Business segments Exhibit 57: Novartis AG - Key news Exhibit 58: Novartis AG - Key offerings Exhibit 59: Novartis AG - Segment focus 10.7 Perrigo Co. Plc Exhibit 60: Perrigo Co. Plc - Overview Exhibit 61: Perrigo Co. Plc - Business segments Exhibit 62: Perrigo Co. Plc - Key news Exhibit 63: Perrigo Co. Plc - Key offerings Exhibit 64: Perrigo Co. Plc - Segment focus 10.8 Pfizer Inc. 10.9 Seikagaku Corp. Exhibit 69: Seikagaku Corp. - Overview Exhibit 70: Seikagaku Corp. - Business segments Exhibit 71: Seikagaku Corp. - Key offerings Exhibit 72: Seikagaku Corp. - Segment focus 10.10 Sun Pharmaceutical Industries Ltd. Exhibit 73: Sun Pharmaceutical Industries Ltd. - Overview Exhibit 74: Sun Pharmaceutical Industries Ltd. - Product and service Exhibit 75: Sun Pharmaceutical Industries Ltd. - Key news Exhibit 76: Sun Pharmaceutical Industries Ltd. - Key offerings 10.11 Teva Pharmaceutical Industries Ltd. Exhibit 77: Teva Pharmaceutical Industries Ltd. - Overview Exhibit 78: Teva Pharmaceutical Industries Ltd. - Business segments Exhibit 79: Teva Pharmaceutical Industries Ltd. - Key offerings Exhibit 80: Teva Pharmaceutical Industries Ltd. - Segment focus 10.12 Viatris Inc. Exhibit 81: Viatris Inc. - Overview Exhibit 82: Viatris Inc. - Business segments Exhibit 83: Viatris Inc. - Key offerings Exhibit 84: Viatris Inc. - Segment focus 11 Appendix 11.1 Scope of the report 11.2 Currency conversion rates for US$ Exhibit 85: Currency conversion rates for US$ 11.3 Research methodology Exhibit 86: Research Methodology Exhibit 87: Validation techniques employed for market sizing Exhibit 88: Information sources 11.4 List of abbreviations Exhibit 89: List of abbreviations About Us Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios. Contact Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio

08 Jun 2021

·www.globenewswire.com

Overactive Bladder Pipeline Shows Rapid Advancements in the

Los Angeles, USA, June 07, 2021 (GLOBE NEWSWIRE) -- Overactive Bladder Pipeline Shows Rapid Advancements in the Clinical Trials: A Review by DelveInsight Overactive Bladder therapies with different mechanisms of action are currently being studied with excellent market potential. Ongoing scientific research has provided with greater sophistication and a clearer understanding of the mechanisms of therapeutic interventions, combined with improved outcome measures to assess the efficacy and patient satisfaction, as well as high-quality Overactive Bladder clinical trials with proper design, which would translate into more refined and directed therapies in future years. DelveInsight’s “Overactive Bladder Pipeline Insight” report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in the Overactive Bladder pipeline landscapes. It comprises Overactive Bladder pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Overactive Bladder therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Overactive Bladder pipeline products. Some of the key takeaways from the Overactive Bladder Pipeline Report Get an overview of pipeline landscape @ Overactive Bladder Clinical Trials Analysis Overactive Bladder (OAB) causes a frequent and sudden urge to urinate that may be difficult to control. One may need to pass urine many times during the day and night and may also experience unintentional loss of urine. There are six antimuscarinic agents available for the OAB treatment worldwide- oxybutynin, tolterodine, fesoterodine, trospium, darifenacin, and solifenacin. Overactive Bladder Emerging Drugs Neuronox, an acetylcholine inhibitor is being developed by Medy-Tox for the treatment of the Overactive Bladder. The active ingredients involve Clostridium botulinum toxin type A. It is currently in the phase III stage of development. In September 2020, US drugmaker Allergan entered into a license agreement with South Korea’s Medytox under the terms of which, on closing, Allergan would pay Medytox an upfront of USD 65 million and Medytox would grant Allergan exclusive rights, worldwide outside of Korea, to develop and, if approved, commercialise certain neurotoxin product candidates currently in development, including a potential liquid-injectable product. In May 2020, AbbVie announced that it had finished its acquisition of Allergan plc. following receipt of regulatory approval from all government authorities needed by the transaction agreement and approval by the Irish High Court. Research and DevelopmentPhase III NCT04113941: In August 2019, Medy-Tox initiated a phase III trial, a randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy and safety of Meditoxin in subject with Idiopathic Overactive Bladder. This study is for patients who have idiopathic overactive bladder symptoms. This study will assess the efficacy and safety of Neuronox against placebo. The trial is currently in the active not recruiting stage with an estimated enrollment of 216 participants and anticipated to be completed in August 2021. Urovant Sciences is developing URO-902 for the treatment of the Overactive Bladder. URO-902 has the potential to be the first gene therapy for OAB patients. This innovative treatment has the capability to tackle an unmet need for patients who have failed oral pharmacologic therapies and are concerned with potential urinary retention or surgical interventions pertinent to existing third-line OAB treatments. It is currently in the phase II stage of development. Research and DevelopmentPhase II NCT04211831: In December 2019, Urovant Sciences GmbH initiated a phase II trial titled “An exploratory phase IIa study evaluating the efficacy and safety of URO-902 in subjects with Overactive Bladder and Urge Urinary Incontinence”. This study will investigate the efficacy, safety, and tolerability of a single dose of URO-902 24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up to 48 weeks post-dose. The trial is currently in recruiting stage with an estimated enrollment of 78 participants and expected to be completed in September 2022. Solabegron is a highly potent and selective beta-3 adrenoceptor agonist that is being developed for Overactive Bladder treatment. Solabegron has been tested in over 800 study subjects in a twice-a-day formulation and demonstrated efficacy in treating OAB and Irritable bowel syndrome (IBS). A once-daily formulation designed to optimise patient convenience and effectiveness has been developed and is currently being evaluated in phase 2b dose-ranging clinical trials. Research and DevelopmentPhase II NCT03594058: In July 2018, Velicept Therapeutics initiated a phase IIb, multicenter, randomised, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of oral solabegron modified-release tablets in the treatment of Overactive Bladder in adult female subjects. The trial enrolled 1413 participants and was completed in May 2019. Results Velicept Therapeutics announced that its next-generation beta-3 adrenoceptor agonist solabegron met the primary endpoint in VEL-2002, a phase IIb study in Overactive Bladder patients. In the study, twice-daily administration of solabegron showed a statistically major improvement compared to placebo at week 12, as measured by the mean change in the number of micturitions per day, the study’s primary endpoint. Solabegron also showed statistical significance across various secondary endpoints, comprising a percent reduction of urge urinary incontinence episodes, dry rate, and urgency episodes. For further information, refer to the detailed report @ Overactive Bladder Pipeline Therapeutics Scope of Overactive Bladder Pipeline Drug Insight Key Questions regarding Current Overactive Bladder Treatment Landscape and Emerging Therapies Answered in the Pipeline Report Table of Contents Get a customised pipeline report @ Overactive Bladder Drugs Pipeline Report Related Reports DelveInsight’s Overactive Bladder Market Insights, Epidemiology and Market Forecast report provides a detailed overview of the disease and a depth understanding of historical data. DelveInsight's Overactive Bladder - Epidemiology Forecast 2030 report delivers an in-depth understanding of the disease, historical, and forecasted epidemiology of Overactive Bladder in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. DelveInsight's "Interstitial Lung Disease - Market Insights, Epidemiology, and Market Forecast-2030" report delivers an in-depth understanding of the Interstitial Lung Disease, historical and forecasted epidemiology. DelveInsight's Interstitial Cystitis - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease. DelveInsight's Bronchiolitis Obliterans Syndrome - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. Checkpoint Kinase Inhibitor Pipeline Insights, 2021 report by DelveInsight offers comprehensive insights of the pipeline (under development) therapeutics scenario and growth prospects across Checkpoint Kinase Inhibitor development. Browse ASCO 2021 Abstracts here:- About DelveInsightDelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also provides Healthcare Consulting services comprising credible market analysis that will help accelerate the business growth and overcome challenges with a practical approach.

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100 Deals associated with Fesoterodine Fumarate

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KEGG	Wiki	ATC	Drug Bank
D08923	Fesoterodine Fumarate	G04BD11	DB06702

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Urinary Bladder, Neurogenic	JP	Pfizer Japan, Inc.	26 Sep 2022
Neurogenic detrusor overactivity	US	Pfizer Inc.	17 Jun 2021
Urinary Incontinence, Urge	JP	Pfizer Japan, Inc.	25 Dec 2012
Urinary Bladder, Overactive	US	Pfizer Inc.	31 Oct 2008
Overactive bladder syndrome	EU	Pfizer Europe MA EEIG	20 Apr 2007
Overactive bladder syndrome	IS	Pfizer Europe MA EEIG	20 Apr 2007
Overactive bladder syndrome	LI	Pfizer Europe MA EEIG	20 Apr 2007
Overactive bladder syndrome	NO	Pfizer Europe MA EEIG	20 Apr 2007

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pollakisuria	Phase 3	CN	Cisen Pharmaceutical Ltd.	25 Aug 2023
Pollakisuria	Phase 3	CN	Guangzhou Bosto Controlled-Release Pharmaceutical Co Ltd.	25 Aug 2023
Urinary urgency	Phase 3	CN	Cisen Pharmaceutical Ltd.	25 Aug 2023
Urinary urgency	Phase 3	CN	Guangzhou Bosto Controlled-Release Pharmaceutical Co Ltd.	25 Aug 2023
Brain Diseases	Phase 3	US	Pfizer Inc.	02 Jul 2012
Brain Diseases	Phase 3	JP	Pfizer Inc.	02 Jul 2012
Brain Diseases	Phase 3	BE	Pfizer Inc.	02 Jul 2012
Brain Diseases	Phase 3	CA	Pfizer Inc.	02 Jul 2012
Brain Diseases	Phase 3	EE	Pfizer Inc.	02 Jul 2012
Brain Diseases	Phase 3	FI	Pfizer Inc.	02 Jul 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04090190 (CTgov)	Phase 4	Urinary Incontinence \| Urinary urgency \| Inflammation	20	Oxybutynin+Tolterodine+Trospium+Solifenacin+Fesoterodine	yyshxbiypq(xtpnghrudf) = lrgnynmdoq whegkbjtdp (urnxnbrtwn, ktpmnkmaov - mekruqtrge) View more	-	03 Oct 2022
NCT03946124 (Pubmed \| Female Pelvic Med Reconstr Surg)	Phase 4	Urinary Bladder, Overactive	75	Fesoterodine	absgyldewc(fzmlmxyewo) = pkbrxhwfpn tidobcdeps (njpmtayvhk )	-	01 Dec 2021
NCT02501928 (CTgov)	Phase 3	Urinary Bladder, Neurogenic \| Neurogenic detrusor overactivity \| Urinary Bladder, Overactive	12	fesoterodine (Cohort 1)	ipyetwooef(yhzljuwbfs) = povdulytie uebtdlnpnb (yepjskknfy, cehbtizwva - nvuzmmxtbl) View more	-	26 Oct 2020
NCT02501928 (CTgov)	Phase 3		12	fesoterodine (Cohort 2)	ipyetwooef(yhzljuwbfs) = vvuvlfzgzt uebtdlnpnb (yepjskknfy, hozauayqpy - jkgflhmjlt) View more	-	26 Oct 2020
NCT03946124 (CTgov)	Phase 4	Urinary Bladder, Overactive	74	Fesoterodine	dwxxbjmope(xulmlpzkab) = rbbgwxyxdm zdbpuopiiz (dpukckdpsz, kzgftcsitb - pvaliftftu) View more	-	11 Dec 2019
AUA2019	Phase 2	Neurogenic detrusor overactivity	10	Fesoterodine	ktvitazset(zpiudtgxey) = yxluesjrsj wbpkasvnrp (iydmmazmrw ) View more	-	01 Apr 2019
NCT00605319 (Toviaz, CTgov)	Phase 4	Prostatic Hyperplasia \| Urinary Bladder Neck Obstruction \| Urinary Bladder, Overactive	17	Toviaz (Fesoterodine)	gfgsfjqvzb(hdvbfzonqt) = lhyzugtidm mreefznyri (jbidqfrrhu, hxlfaevhwr - rclbvibxti) View more	-	10 Apr 2018
AUA2016	Not Applicable	Urinary Bladder, Overactive	33	EARLY MUSCARINIC BLOCKADE (SCT control)	gkgtsovjmu(isoxxcuwkr) = dseyjwheww effmbpclth (wenpqiehzd ) View more	-	01 Apr 2016
NCT01367886 (CTgov)	Not Applicable	Urinary Bladder, Overactive	21	fesoterodine	kccfhsxujd(tclzhmafds) = ugfukiqbqs dfxdxhrbvh (vdwhqnghog, tefuadcden - xlgwkyeqaj) View more	-	12 Jan 2015
PD23-02 (AUA2014)	Not Applicable	Lower Urinary Tract Symptoms	67	Fesoterodine 4-8mg	rxpizblfrm(saremjsrej) = yqehzhnlel jbftojmyfw (qspgspvhbs )	Positive	01 Apr 2014
NCT00928070 (Pubmed \| J Urol)	Phase 4	Urinary Incontinence	562	Fesoterodine	sshixxmldg(ukjekfvxvm) = pyrhbykvqu zaxnkhlsrx (jubfkazgex )	Positive	01 Feb 2014
NCT00928070 (Pubmed \| J Urol)	Phase 4	Urinary Incontinence	562	Placebo	sshixxmldg(ukjekfvxvm) = mrkfmupnvw zaxnkhlsrx (jubfkazgex )	Positive	01 Feb 2014

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