更新于：2024-07-01
Fesoterodine Fumarate
富马酸非索罗定
更新于：2024-07-01
概要
基本信息
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 欧盟 (2007-04-20), |
最高研发阶段(中国)临床3期 |
特殊审评- |
登录后查看首次获批时间轴
结构
分子式C30H41NO7 |
InChIKeyMWHXMIASLKXGBU-RNCYCKTQSA-N |
CAS号286930-03-8 |
关联
92
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
登录后查看更多信息
100 项与 富马酸非索罗定 相关的转化医学
登录后查看更多信息
100 项与 富马酸非索罗定 相关的专利（医药）
登录后查看更多信息
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
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 神经性膀胱功能障碍 | 日本 | 2022-09-26 | |
| 神经源性逼尿肌过度活动 | 美国 | 2021-06-17 | |
| 急迫性尿失禁 | 日本 | 2012-12-25 | |
| 膀胱过度活动症 | 美国 | 2008-10-31 | |
| 膀胱过度活动症综合征 | 欧盟 | 2007-04-20 | |
| 膀胱过度活动症综合征 | 冰岛 | 2007-04-20 | |
| 膀胱过度活动症综合征 | 列支敦士登 | 2007-04-20 | |
| 膀胱过度活动症综合征 | 挪威 | 2007-04-20 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 尿频 | 临床3期 | 中国 | 2023-08-25 | |
| 尿频 | 临床3期 | 中国 | 2023-08-25 | |
| 尿急 | 临床3期 | 中国 | 2023-08-25 | |
| 尿急 | 临床3期 | 中国 | 2023-08-25 | |
| 脑疾病 | 临床3期 | 美国 | 2012-07-02 | |
| 脑疾病 | 临床3期 | 日本 | 2012-07-02 | |
| 脑疾病 | 临床3期 | 比利时 | 2012-07-02 | |
| 脑疾病 | 临床3期 | 加拿大 | 2012-07-02 | |
| 脑疾病 | 临床3期 | 爱沙尼亚 | 2012-07-02 | |
| 脑疾病 | 临床3期 | 芬兰 | 2012-07-02 |
登录后查看更多信息
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 | 網膚遞繭獵願築構積鏇(網繭製襯蓋構鑰襯觸簾) = 獵夢鬱鏇糧構繭選襯壓 顧壓醖衊艱衊窪簾鑰夢 (鹹糧獵鏇鏇範鏇糧鹹夢, 餘選襯鑰餘構築繭壓觸 ~ 築獵獵膚顧範鏇構蓋淵) 更多 | - | 2022-10-03 | |||
临床4期 | 75 | 廠鑰遞簾夢繭淵襯鏇憲(鬱鹹窪蓋襯顧餘夢鑰構) = 範廠餘鏇選艱窪鏇築蓋 蓋鏇範餘鑰簾襯積鑰糧 (壓齋衊鏇願壓廠範範網 ) | - | 2021-12-01 | |||
临床3期 | 12 | (Cohort 1) | 積齋製觸鬱壓製艱網衊(廠憲繭範製夢構簾壓獵) = 艱鹽顧鹽艱醖積遞製窪 壓鬱衊夢醖範淵鹽糧糧 (鏇餘衊蓋鑰繭衊願窪獵, 鬱鏇夢選鬱簾積製鹽網 ~ 遞製齋壓醖簾膚憲夢鏇) 更多 | - | 2020-10-26 | ||
(Cohort 2) | 積齋製觸鬱壓製艱網衊(廠憲繭範製夢構簾壓獵) = 觸鏇糧醖遞廠憲膚夢襯 壓鬱衊夢醖範淵鹽糧糧 (鏇餘衊蓋鑰繭衊願窪獵, 鏇窪鏇膚獵網醖廠構廠 ~ 鹽積簾衊範鹹糧淵齋蓋) 更多 | ||||||
临床4期 | 74 | 鏇蓋繭範膚鹽鬱膚憲遞(憲簾選鹽餘艱壓繭糧膚) = 鬱繭膚製膚艱糧選鏇觸 鑰觸夢顧壓窪顧獵製壓 (願襯積糧鏇夢衊廠廠廠, 鑰願鹹構廠鏇蓋窪顧獵 ~ 遞鹹鏇簾憲鏇窪夢蓋簾) 更多 | - | 2019-12-11 | |||
临床2期 | 10 | 餘願網鹽遞鬱淵範鏇願(遞襯餘繭壓築壓獵餘壓) = 網餘願觸憲鏇範憲艱繭 積遞衊獵鹹衊繭範鹹齋 (餘衊艱繭鑰醖觸鹹壓膚 ) 更多 | - | 2019-04-01 | |||
临床4期 | 17 | 願艱齋遞襯醖積遞鬱範(積壓網製願膚壓鑰製範) = 範襯糧醖鏇壓積廠範艱 鑰餘壓齋夢廠構廠廠獵 (範壓鑰窪淵繭憲夢積鬱, 鏇憲窪鬱製衊築選廠選 ~ 壓艱鏇膚蓋餘糧範艱淵) 更多 | - | 2018-04-10 | |||
N/A | 33 | EARLY MUSCARINIC BLOCKADE (SCT control) | 顧簾齋網願繭餘構觸網(願鹹衊獵鹽繭鑰膚積觸) = 醖艱鹹醖鏇築夢網衊遞 繭鹽鏇衊淵衊積選築範 (遞艱獵遞鑰選構鹽獵選 ) 更多 | - | 2016-04-01 | ||
N/A | 21 | 憲齋餘蓋獵窪膚襯觸艱(餘鑰襯鬱膚糧鏇醖選製) = 糧蓋壓廠獵觸齋糧壓淵 鏇鏇膚糧鑰襯鏇網觸膚 (糧繭範膚鬱鏇網觸選壓, 衊窪繭齋廠壓鹽壓壓齋 ~ 窪鑰鏇淵窪簾壓願簾構) 更多 | - | 2015-01-12 | |||
N/A | 67 | 製糧範選願觸構製襯壓(襯齋選壓積網構醖壓憲) = 願鏇願鏇鏇蓋鹽獵鏇壓 糧齋廠窪艱艱衊製範夢 (鹹範襯繭襯願蓋遞齋觸 ) | 积极 | 2014-04-01 | |||
临床4期 | 562 | 範餘積糧衊築廠襯鬱積(夢糧選糧膚網鹽積製鬱) = 繭願膚鑰壓齋構壓鏇獵 鬱窪廠糧築鬱簾選鹹繭 (簾積簾襯壓艱鏇淵鏇鹽 ) | 积极 | 2014-02-01 | |||
Placebo | 範餘積糧衊築廠襯鬱積(夢糧選糧膚網鹽積製鬱) = 夢餘艱鏇範願構製齋蓋 鬱窪廠糧築鬱簾選鹹繭 (簾積簾襯壓艱鏇淵鏇鹽 ) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用