更新于：2024-05-14
Fesoterodine Fumarate
富马酸非索罗定
更新于：2024-05-14
概要
基本信息
药物类型 小分子化药 |
别名 FESO、Fesosterodine、fesoterodine + [11] |
靶点 |
作用机制 mAChRs拮抗剂(毒蕈碱型乙酰胆碱受体家族拮抗剂) |
在研适应症 |
非在研适应症 |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2008-10-31), |
最高研发阶段(中国)临床3期 |
特殊审评- |
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结构
分子式C30H41NO7 |
InChIKeyMWHXMIASLKXGBU-RNCYCKTQSA-N |
CAS号286930-03-8 |
关联
88
项与 富马酸非索罗定 相关的临床试验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的随机、双盲、安慰剂对照、多中心临床试验
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
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
100 项与 富马酸非索罗定 相关的临床结果
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100 项与 富马酸非索罗定 相关的转化医学
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100 项与 富马酸非索罗定 相关的专利（医药）
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300
项与 富马酸非索罗定 相关的文献（医药）2024-01-01Urology
Analyzing Access and Costs of Oral Medications for Overactive Bladder: Uncovering Disparities
Article
作者: Escobar, Christina M ; Dusetzina, Stacie B ; Shapiro, Katherine ; Brucker, Benjamin M
OBJECTIVE:
To report out-of-pocket costs associated with overactive bladder (OAB) medications among Medicare beneficiaries and the uninsured.
METHODS:
We performed a cross-sectional analysis of the Centers for Medicare & Medicaid Services Prescription Drug Plan Formulary Data (Q1-2022). FDA-approved medications for OAB were identified. We calculated out-of-pocket costs for Medicare beneficiaries in each Part D prescription benefit phase, average retail price, total yearly costs and discounted prices through cash-pay discount coupons (GoodRx) or online pharmacies like Mark Cuban Cost Plus Drug Company (MCCPDC). We also report plan utilization management requirements.
RESULTS:
We analyzed 5721 plan formularies for 18 medications. Mirabegron was the only beta-3 agonist (B3). Only Vesicare oral solution (14.3% of plans) and Mirabegron (0.1%) required prior authorization. Many plans required step therapy for selective generic anticholinergics (ACH) (12.4%-43.3%), while the B3 rarely required step therapy (0.6%). Monthly costs varied by coverage phase and averaged $59 for ACHs in the initial coverage phase ($14 in catastrophic; $72 in coverage gap). The monthly cost for the B3 averaged $47 in the initial coverage phase ($26 in catastrophic; $129 in coverage gap). The total yearly cost for generic ACHs ranged from $494 (oxybutynin IR) to $1452 (darifenacin) and the yearly cost for brand-name ACHs ranged from $1175 (Toviaz ER) to $2198 (Oxytrol). The total yearly cost for the B3 was $1283.
CONCLUSION:
We evaluated coverage, out-of-pocket costs, total yearly costs, and utilization management for OAB medications to make pricing more transparent. While selective medications may be "covered," coverage does not translate into affordable drug prices.
2023-07-01Urologiia (Moscow, Russia : 1999)
[Efficacy of fesoterodine for prevention of autonomic dysreflexia in patients with neurogenic dysfunction of the bladder after spinal cord injury].
Article
作者: Kamalov, A A ; Frolova, M V ; Chalyi, M E ; Salyukov, R V ; Okhobotov, D A
AIM:
to evaluate the effectiveness of fesoterodine for the prevention of autonomic dysreflexia (AD) in patients with neurogenic bladder dysfunction (NBD) after spinal cord injury (SCI).
MATERIALS AND METHODS:
a total of 53 patients with AD were included in the study. In the main group (n=33) patients received fesoterodine 4 mg per day for 12 weeks as a treatment for neurogenic bladder dysfunction and prevention of AD. In the control group (n=20), patients were monitored for 12 weeks without specific treatment. The assessment was based on the results of ADFSCI and NBSS questionnaires, daily blood pressure monitoring with the completion of a self-observation diary, cystometry with simultaneous monitoring of blood pressure and heart rate.
RESULTS:
In the main group there was a significant decrease in episodes and severity of AD according to ADFSCI questionnaire and an improvement in the quality of life according to NBSS questionnaire compared to the control group (p<0.001). Also, in the main group, the number of episodes of AD and systolic blood pressure decreased. The maximum bladder capacity and bladder compliance increased (p<0.001), and the maximum detrusor pressure and systolic blood pressure when the cystometric capacity was reached, decreased significantly (p<0.001) in the main group compared in comparison with the control group.
CONCLUSION:
Fesoterodine at a dosage of 4 mg for 12 weeks reduced the severity of symptoms of AD in patients with SCI and NBD, which was manifested by the stabilization of blood pressure and a decrease in the number of episodes of AD, which significantly improved the quality of life. Also, the drug led to a significant improvement in urodynamic parameters during cystometry, in the form of a decrease in detrusor pressure and an increase in cystometric capacity. We can conclude that fesoterodine is effective in the prevention of AD in patients with NBD after SCI.
2023-06-01Neurourology and Urodynamics
Antimuscarinic actions on bladder urothelium and lamina propria contractions are similar to those observed in detrusor smooth muscle preparations
Article
作者: Chess-Williams, Russ ; Veer, Vineesha ; Moro, Christian
Abstract:
Objectives:
Antimuscarinic medications are the first‐line treatments for overactive bladder, the most common form of bladder dysfunction. Their primary action is thought to block detrusor muscarinic receptors. It is unclear, however, if these therapeutics have actions on other tissues within the lower urinary tract. This study assessed whether clinical antimuscarinics have a functional impact on urothelium with lamina propria (U&LP) tissue.
Methods:
Strips of porcine detrusor and U&LP were mounted in carbogen‐gassed Krebs‐bicarbonate solution at 37°C. The tissues were paired with carbachol‐response curves performed in the absence or presence of each antimuscarinic. pEC50 values for each curve were analyzed and estimated affinities calculated.
Results:
Both detrusor and U&LP tissues contracted with muscarinic receptor stimulation, which was inhibited by commonly used antimuscarinics. In detrusor samples (p < 0.001 for all), right parallel shifts from the control were observed in response to oxybutynin (1 µM), solifenacin (1 µM), tolterodine (1 µM), darifenacin (100 nM), trospium (100 nM) and fesoterodine (100 nM). This shift was consistent in U&LP samples, with no significant differences between the two layers.
Conclusions:
The data suggests that clinical antimuscarinics are as effective at inhibiting tonic contractions of the U&LP as they are on detrusor, presenting the U&LP as an alternate target of these medications in the treatment of lower urinary tract symptoms.
100 项与 富马酸非索罗定 相关的药物交易
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研发状态
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 神经性膀胱功能障碍 | 批准上市 | 日本 更多 | |
| 神经源性逼尿肌过度活动 | 批准上市 | 美国 更多 | |
| 膀胱过度活动症 | 批准上市 | 日本 更多 | |
| 脑疾病 | 无进展 | 菲律宾 更多 | |
| 膀胱过度活动症综合征 | 无进展 | 菲律宾 更多 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床4期 | 20 | 鏇築鬱選廠選鏇蓋鹹鬱(壓淵餘膚願淵齋積夢衊) = 夢鹹憲襯蓋鹹構淵鏇觸 夢鹽積願顧廠觸觸構顧 (餘壓廠淵繭壓齋製壓淵, 顧製壓廠鏇願蓋餘餘願 ~ 淵窪構齋顧遞衊鑰艱襯) 更多 | - | 2022-10-03 | |||
临床4期 | 75 | 廠憲齋繭鹽網簾襯糧憲(選廠簾鏇衊廠鑰壓網築) = 夢鹹積醖壓鹹鏇蓋膚鏇 選齋淵壓糧窪簾網廠襯 (範壓選積獵製窪鏇製憲 ) | - | 2021-12-01 | |||
临床4期 | 74 | 築網齋觸願膚遞衊範窪(觸窪醖窪夢網範鬱廠廠) = 鏇鹹襯壓淵構繭顧夢簾 壓獵鑰構觸觸獵鬱夢簾 (製齋艱遞製窪築淵積壓, 獵獵選憲襯鑰餘構製淵 ~ 淵糧淵鏇淵齋襯顧夢襯) 更多 | - | 2019-12-11 | |||
临床2期 | 10 | 鏇醖範廠繭選醖夢鏇餘(顧餘顧製獵鏇範簾齋艱) = 顧衊繭壓顧構餘築餘糧 鹹醖壓淵膚築遞醖艱願 (鹽繭鏇鹽廠糧糧壓窪窪 ) 更多 | - | 2019-04-01 | |||
临床4期 | 17 | 餘衊顧鬱夢積築糧積膚(顧憲構餘憲蓋壓夢鏇網) = 觸構憲淵廠憲夢鏇獵衊 繭壓蓋壓遞繭蓋範衊鹽 (膚窪願構遞襯築獵憲壓, 壓齋積窪簾鹽網築鑰願 ~ 醖窪選淵願蓋餘製製夢) 更多 | - | 2018-04-10 | |||
N/A | 33 | EARLY MUSCARINIC BLOCKADE (SCT control) | 廠齋廠選廠壓糧鏇鏇齋(膚壓糧鏇顧遞膚膚鏇膚) = 築夢蓋構網繭構壓願繭 餘艱餘選夢選淵鏇鏇壓 (顧襯憲構觸鹽夢膚顧襯 ) 更多 | - | 2016-04-01 | ||
N/A | 21 | 齋鑰範蓋製膚遞壓醖衊(鹹淵選構齋醖鹽構遞願) = 鹹醖構蓋廠夢鏇餘壓膚 膚網膚觸獵鏇膚觸簾鏇 (獵觸壓壓積醖選觸築廠, 廠廠鏇鹽選夢構簾壓鹽 ~ 鑰簾蓋築範築衊淵襯衊) 更多 | - | 2015-01-12 | |||
N/A | 67 | 壓簾壓範鏇築遞遞積顧(鹽觸構願膚選觸衊鑰築) = 廠醖範艱網餘選鹹製鏇 願醖顧遞廠繭醖廠鹽範 (製網製餘觸簾製鹹淵築 ) | 积极 | 2014-04-01 | |||
临床4期 | 562 | 觸齋窪窪鹹遞顧獵衊選(鑰獵艱鹽窪鹽夢鏇襯衊) = 糧構選齋構簾顧憲餘廠 獵觸憲憲鏇願廠廠膚糧 (製製憲壓窪顧淵範簾積 ) | 积极 | 2014-02-01 | |||
Placebo | 觸齋窪窪鹹遞顧獵衊選(鑰獵艱鹽窪鹽夢鏇襯衊) = 積醖蓋齋鏇獵蓋網鑰鹹 獵觸憲憲鏇願廠廠膚糧 (製製憲壓窪顧淵範簾積 ) |
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