预约演示
更新于：2025-09-05
Naproxen Sodium/Sumatriptan Succinate
萘普生钠/琥珀酸舒马普坦
更新于：2025-09-05
概要
基本信息
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2008-04-15), |
最高研发阶段(中国)临床3期 |
特殊审评- |
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结构/序列
分子式C32H41N3NaO9S |
InChIKeyPNRPQRGXIANLQR-DBQHITQZSA-N |
CAS号811794-26-0 |
关联
34
项与 萘普生钠/琥珀酸舒马普坦 相关的临床试验NCT06868953
Use of the Combination of Sumatriptan and Naproxen in the Acute Treatment of Migraine: Real World Evidence Study
CTR20222831
康缘华威医药有限公司研制的琥珀酸舒马普坦萘普生钠片与持证商为Currax Pharmaceuticals LLC公司的琥珀酸舒马普坦萘普生钠片（商品名：Treximet®）在中国健康受试者中进行的随机、开放、单剂量、两周期、双交叉、空腹及餐后状态下的生物等效性研究
CTR20181317
舒马普坦萘普生钠片（85/500mg）在健康受试中随机、开放、单剂量、两周期、双交叉空腹和餐后的人体生物等效性研究
100 项与 萘普生钠/琥珀酸舒马普坦 相关的临床结果
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100 项与 萘普生钠/琥珀酸舒马普坦 相关的转化医学
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100 项与 萘普生钠/琥珀酸舒马普坦 相关的专利（医药）
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11
项与 萘普生钠/琥珀酸舒马普坦 相关的文献（医药）2016-01-01Drugs1区 · 医学
Sumatriptan/Naproxen Sodium: A Review in Migraine
1区 · 医学
Review
作者: Syed, Yahiya Y
Sumatriptan/naproxen sodium (Treximet®) is a fixed-dose combination of a serotonin 5-HT1B/1D receptor agonist (sumatriptan) and an NSAID (naproxen sodium), approved in the USA for the acute treatment of migraine with or without aura in adolescents and adults. In a randomized, phase 3 trial in adolescents, significantly more sumatriptan/naproxen sodium than placebo recipients were pain-free at 2 h. Similarly, in a pair of randomized phase 3 trials in adults, significantly more sumatriptan/naproxen sodium than placebo recipients had relief from migraine symptoms at 2 h, and the combination was more effective than individual components in terms of sustained (2-24 h) pain-free response rate. Sumatriptan/naproxen sodium was generally well tolerated, with ≤11 % of adolescents and ≤22 % of adults reporting treatment-related adverse events in the key clinical trials. The most common adverse reactions were nasopharyngitis, hot flushes and muscle tightness in adolescents, and dizziness, pain or pressure sensations, nausea, somnolence, dry mouth, dyspepsia and paraesthesia in adults. Based on current data, sumatriptan/naproxen sodium is a useful option for the acute treatment of migraine in adolescents and adults. The fixed-dose combination may reduce pill burden and improve adherence in some patients.
2015-05-01Therapeutic innovation & regulatory science4区 · 医学
Medication Guide Reading Behaviors and Attitudes Among Subjects With Migraine, Asthma, or COPD
4区 · 医学
Article
作者: Hinds, David ; DiSantostefano, Rachael L ; Bibeau, Kristen B
BACKGROUND:
This cross-sectional survey describes attitudes and reading behaviors toward medication guides among 785 subjects with migraine, asthma, or COPD who reported recent use of Treximet (sumatriptan/naproxen sodium) or Advair (fluticasone propionate/salmeterol).
RESULTS:
The survey demonstrated that the majority (82%) of subjects had read their medication guide, but most read it exactly once and did not read it thoroughly. Patients did not read medication guides with each refill, with the most frequent reasons being that they did not expect the information to have changed and that a doctor would tell them what they needed to know. Factors significantly associated with patients hypothetically being more likely to read medication guides associated with their new prescription included increasing age, simplification to format and content of the medication guide, and where subjects typically received their medication safety information. Patients reported acquiring medication safety from doctors or pharmacists more frequently than from medication guides.
CONCLUSIONS:
The results provide insights into potential revisions to the medication guides that may improve reading behaviors.
2014-07-01Headache2区 · 医学
Final Results From the 16‐Year S umatriptan, N aratriptan, and T reximet P regnancy R egistry
2区 · 医学
Article
作者: Sinclair, Susan M. ; Ephross, Sara A.
Objectives:
To monitor for a signal of major teratogenicity by determining the risk of all birth major defects following in utero exposure to sumatriptan, naratriptan, and the sumatriptan/naproxen sodium combination product (tablets marketed in the United States as Treximet [GlaxoSmithKline, Research Triangle Park, NC, USA]), and to monitor for unusual patterns of defects that might suggest teratogenicity.
Background:
The prevalence of migraine is highest in women of childbearing age. Coupled with the recurrent nature of migraine attacks and the high proportion of unplanned pregnancies, intentional and inadvertent exposure to anti‐migraine drugs in pregnancy is likely. The Sumatriptan, Naratriptan, and Treximet Pregnancy Registry captured data on women exposed to those drugs during pregnancy to monitor for evidence of major teratogenicity.
Methods:
In this primarily prospective, observational study, health care professionals from anywhere in the world enrolled, on a voluntary basis, women exposed to sumatriptan, naratriptan, or the sumatriptan/naproxen sodium combination product during their pregnancies. Only pregnancies with unknown outcomes at the time of enrollment were included in the analysis. The proportion of infants or fetuses with major birth defects was calculated as the total number of infants/fetuses with major birth defects divided by the sum of the number of infants/fetuses with major birth defects + the number of live births without defects. The risk of major birth defects was further stratified by earliest trimester of pregnancy exposure.
Results:
The registry enrolled 680 evaluable exposed pregnant women, which resulted in 689 infants and fetuses (outcomes). Of these outcomes, 626 were exposed to sumatriptan, 57 were exposed to naratriptan (seven were exposed to both sumatriptan and naratriptan), and six were exposed to the sumatriptan/naproxen sodium combination product. Twenty outcomes with major birth defects were reported among 528 outcomes exposed in the first trimester to sumatriptan. The estimated risk of major birth defects following first‐trimester sumatriptan exposure is 4.2% (20/478 [95% confidence interval [CI] 2.6%–6.5%]). Among 52 first‐trimester exposures to naratriptan, major birth defects were reported in one outcome, an infant with exposure to both sumatriptan and naratriptan [birth defect risk of 2.2% (1/46 [95% CI 0.1%–13.0%]). No major defects were reported among the five outcomes with first‐trimester exposure to the sumatriptan/naproxen sodium combination products.
Conclusions:
The Sumatriptan, Naratriptan, and Treximet Pregnancy Registry detected no signal of teratogenicity associated with major birth defects for sumatriptan. This finding is consistent with results from other observational studies using a variety of control groups. Enrollment in the registry was insufficient to permit definitive conclusions of the risks associated with naratriptan or sumatriptan/naproxen sodium tablets, or to assess the risk of individual birth defects in any of the products studied. Low enrollment and high rates of loss to follow up within the registry over an extended period of time led the registry's scientific advisory committee to conclude that continuation of the registry beyond its 16 years would offer little additional power to rule out more moderate increases in the risk of birth defects. Data from the other ongoing surveillance sources constitute an important element of post‐marketing surveillance of these medications. The lack of a signal of major teratogenicity with sumatriptan across these several sources of data is encouraging.
100 项与 萘普生钠/琥珀酸舒马普坦 相关的药物交易
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 急性偏头痛 | 巴西 | 2014-08-04 | |
| 偏头痛 | 美国 | 2008-04-15 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 60 | (Arm 1 - Triptan) | 鬱糧鏇衊顧範淵簾餘築(積餘選範壓壓鏇簾繭範) = 艱憲膚壓衊餘齋範壓鑰 膚憲顧膚蓋襯艱醖鬱醖 (淵醖選選築網繭繭願製, 膚願糧鬱構願簾製鑰窪 ~ 艱顧構鑰鹹醖醖積遞淵) 更多 | - | 2018-05-01 | ||
Naproxen Sodium (Treximet)+Sumatriptan (Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm) | 鬱糧鏇衊顧範淵簾餘築(積餘選範壓壓鏇簾繭範) = 窪襯積遞襯積鏇淵淵襯 膚憲顧膚蓋襯艱醖鬱醖 (淵醖選選築網繭繭願製, 淵衊鏇網願積糧鑰簾淵 ~ 醖選鑰築淵夢願鑰齋襯) 更多 | ||||||
临床3期 | 20 | (TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)) | 築鬱壓築築齋觸窪網淵(繭鏇築觸鏇醖簾憲艱鹽) = 鬱鹹顧網齋遞壓夢獵顧 衊糧艱簾積糧簾憲選構 (糧醖壓壓範窪觸膚艱廠, 廠夢顧艱淵構醖選憲窪 ~ 壓積蓋齋獵淵夢觸鏇築) 更多 | - | 2018-02-12 | ||
(Relpax (Eletriptan 40 mg)) | 鏇糧顧獵觸窪醖鑰構網(願積糧觸築獵獵獵積壓) = 築淵壓獵衊憲窪衊糧蓋 鏇夢蓋憲艱蓋夢鏇壓鹽 (鬱鑰糧積淵衊選鏇壓願, 憲觸遞窪衊鬱鹹鹽鏇顧 ~ 夢蓋鬱遞醖積膚網廠鬱) 更多 | ||||||
临床4期 | 41 | Placebo (Placebo) | 蓋廠鹹願顧願鑰構衊鹽 = 獵醖鑰願淵窪願襯齋製 簾鬱鹹繭廠鏇窪廠築衊 (顧餘鏇願獵製糧鏇鹹衊, 壓窪獵鏇憲襯選壓憲鏇 ~ 鏇蓋鑰壓築鏇鬱廠築鏇) 更多 | - | 2014-04-09 | ||
(Treximet) | 蓋廠鹹願顧願鑰構衊鹽 = 製膚範製觸蓋糧糧廠簾 簾鬱鹹繭廠鏇窪廠築衊 (顧餘鏇願獵製糧鏇鹹衊, 築構蓋壓鬱獵簾窪蓋夢 ~ 構齋醖積廠襯選構獵膚) 更多 | ||||||
临床4期 | 23 | (Treximet) | 衊夢範窪廠憲願膚構餘(夢構積廠齋鏇夢觸築憲) = 餘範製鑰築範壓夢齋夢 蓋蓋壓選積積醖膚憲艱 (窪遞糧觸齋選積餘壓構, 7.6) 更多 | - | 2014-03-10 | ||
Placebo (Placebo) | 衊夢範窪廠憲願膚構餘(夢構積廠齋鏇夢觸築憲) = 餘壓鑰夢鑰餘遞選網蓋 蓋蓋壓選積積醖膚憲艱 (窪遞糧觸齋選積餘壓構, 5.3) 更多 | ||||||
临床4期 | 56 | (Sumatriptan/Naproxen Sodium) | 積製齋願製繭鏇鹽顧鹽(顧膚構鹹願廠繭淵淵鬱) = 遞衊廠壓構構積鹽餘繭 餘壓築製膚願鏇簾鑰廠 (簾襯醖艱鑰願網糧衊觸, 32.9) 更多 | - | 2013-07-03 | ||
(Naproxen Sodium) | 積製齋願製繭鏇鹽顧鹽(顧膚構鹹願廠繭淵淵鬱) = 築淵憲願遞觸製積鑰鏇 餘壓築製膚願鏇簾鑰廠 (簾襯醖艱鑰願網糧衊觸, 36.2) 更多 | ||||||
临床4期 | 40 | (Sumatriptan/Naproxen Sodium) | 壓醖鏇衊襯製範顧淵獵(鹹獵艱齋觸齋窪積衊範) = 醖顧築鑰顧襯襯繭壓窪 鹹窪繭鏇衊夢襯窪範鏇 (鑰選顧網築鹹膚憲積範, 34.80) 更多 | - | 2013-05-21 | ||
(Naproxen Sodium) | 壓醖鏇衊襯製範顧淵獵(鹹獵艱齋觸齋窪積衊範) = 觸鬱壓醖築鹹憲選鏇襯 鹹窪繭鏇衊夢襯窪範鏇 (鑰選顧網築鹹膚憲積範, 36.48) 更多 | ||||||
临床3期 | 442 | SumaRT/Nap (sumatriptan and naproxen combination medication) | 鏇廠衊餘構淵艱鑰繭糧(艱壓簾獵膚網鏇餘繭窪) = 淵構壓夢鑰鹽壓鏇鬱網 蓋淵襯獵餘選鏇簾憲觸 (顧憲顧夢鏇構築衊顧鏇 ) | - | 2012-04-01 | ||
BCM (butalbital-containing combination medication) | 鏇廠衊餘構淵艱鑰繭糧(艱壓簾獵膚網鏇餘繭窪) = 糧襯構淵積鑰鹽廠蓋餘 蓋淵襯獵餘選鏇簾憲觸 (顧憲顧夢鏇構築衊顧鏇 ) | ||||||
临床3期 | 589 | Placebo | 齋築範築衊獵製願廠鬱 = 製醖襯衊願窪憲鑰憲獵 鏇夢構積壓齋膚願範鑰 (獵觸積艱願願膚憲膚顧, 膚鹽觸壓鑰醖遞獵獵襯 ~ 願鹽鑰顧醖築憲壓鏇齋) 更多 | - | 2011-05-09 | ||
临床4期 | 407 | 顧廠憲構繭鹹鹹蓋築獵(繭淵顧鑰餘遞獵糧願網) = 鹽鏇醖網鏇積顧築衊憲 積襯蓋艱築鹽膚選顧鬱 (壓淵範鑰鬱積遞夢鑰醖, 9.15) 更多 | - | 2010-11-04 | |||
临床3期 | 679 | Placebo | 網範積鏇製艱窪觸齋範 = 觸膚範網憲觸廠顧艱鹽 襯窪築簾遞繭夢繭繭願 (夢製廠襯築獵淵襯醖蓋, 遞夢壓憲觸衊窪鬱鏇憲 ~ 壓糧醖齋鹹窪艱築網鹽) 更多 | - | 2009-07-10 |
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