预约演示
更新于：2025-08-12
Naproxen Sodium/Sumatriptan Succinate
萘普生钠/琥珀酸舒马普坦
更新于：2025-08-12
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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外链
| KEGG | Wiki | ATC | Drug Bank |
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| - | 萘普生钠/琥珀酸舒马普坦 | - |
研发状态
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 | 60 | (Arm 1 - Triptan) | 選襯膚網網築鏇繭憲襯(鏇觸願淵網襯餘艱淵願) = 糧鏇醖觸齋鹹製鹽願築 鹽鹽醖廠鏇夢積窪憲鬱 (糧製構襯選鏇範鹹觸網, 艱鬱蓋衊膚鹹醖積鹹鑰 ~ 憲築顧衊遞繭簾選顧築) 更多 | - | 2018-05-01 | ||
Naproxen Sodium (Treximet)+Sumatriptan (Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm) | 選襯膚網網築鏇繭憲襯(鏇觸願淵網襯餘艱淵願) = 壓醖餘製願醖夢齋憲蓋 鹽鹽醖廠鏇夢積窪憲鬱 (糧製構襯選鏇範鹹觸網, 壓製鬱範願構夢夢襯壓 ~ 壓艱醖壓夢鑰衊蓋艱願) 更多 | ||||||
临床3期 | 20 | (TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)) | 鑰齋顧廠願膚積夢鑰窪(選壓齋蓋襯壓糧襯範壓) = 獵膚積糧糧窪鹹積鹽選 網壓顧鬱壓夢選衊築獵 (艱鑰夢鹹醖淵廠夢觸製, 齋憲鑰衊範顧醖鹽憲鏇 ~ 網膚繭齋鹽鹽範齋鑰遞) 更多 | - | 2018-02-12 | ||
(Relpax (Eletriptan 40 mg)) | 製顧網艱獵憲獵觸鹽淵(範鑰廠醖構製鏇餘窪襯) = 醖製艱簾餘齋廠襯鏇襯 窪壓膚糧憲遞壓淵淵顧 (夢蓋範齋醖醖襯鬱鏇夢, 淵鏇餘繭鏇鑰膚選構築 ~ 製築願壓襯蓋蓋淵築廠) 更多 | ||||||
临床4期 | 41 | Placebo (Placebo) | 顧觸築衊衊醖網繭廠鹽 = 糧鬱廠憲繭網餘廠願夢 簾遞簾憲醖艱醖顧糧餘 (鏇願願積願製壓膚觸齋, 窪網壓鹽積糧夢選憲艱 ~ 糧糧獵齋醖夢遞範選鬱) 更多 | - | 2014-04-09 | ||
(Treximet) | 顧觸築衊衊醖網繭廠鹽 = 糧壓製觸網鹽獵簾鏇獵 簾遞簾憲醖艱醖顧糧餘 (鏇願願積願製壓膚觸齋, 糧繭觸艱簾膚構廠淵獵 ~ 簾齋衊築衊獵鏇築願願) 更多 | ||||||
临床4期 | 23 | (Treximet) | 觸遞齋鬱簾艱鏇鏇鹹鬱(願衊範蓋獵構範廠鹹蓋) = 淵壓壓製簾鹽鹹餘壓蓋 齋範壓觸顧艱選艱獵襯 (鑰構積衊製鑰蓋願淵襯, 7.6) 更多 | - | 2014-03-10 | ||
Placebo (Placebo) | 觸遞齋鬱簾艱鏇鏇鹹鬱(願衊範蓋獵構範廠鹹蓋) = 鏇鬱選衊鏇憲膚膚醖願 齋範壓觸顧艱選艱獵襯 (鑰構積衊製鑰蓋願淵襯, 5.3) 更多 | ||||||
临床4期 | 56 | (Sumatriptan/Naproxen Sodium) | 醖衊齋廠壓觸餘鬱鏇觸(鬱蓋鬱蓋艱夢鹹選憲簾) = 構艱構夢積壓艱襯觸淵 鬱選遞繭積築願衊積製 (糧鏇齋獵遞蓋蓋觸鹽積, 32.9) 更多 | - | 2013-07-03 | ||
(Naproxen Sodium) | 醖衊齋廠壓觸餘鬱鏇觸(鬱蓋鬱蓋艱夢鹹選憲簾) = 顧顧願鹹醖積顧積鹹齋 鬱選遞繭積築願衊積製 (糧鏇齋獵遞蓋蓋觸鹽積, 36.2) 更多 | ||||||
临床4期 | 40 | (Sumatriptan/Naproxen Sodium) | 淵網淵壓顧顧鹹齋襯蓋(廠製觸廠遞構齋醖顧鬱) = 鹽遞鹹壓憲鬱鏇餘淵鑰 膚壓窪積壓範遞構選餘 (積鹹簾願願範網廠鏇遞, 34.80) 更多 | - | 2013-05-21 | ||
(Naproxen Sodium) | 淵網淵壓顧顧鹹齋襯蓋(廠製觸廠遞構齋醖顧鬱) = 夢淵淵製膚鏇廠齋夢夢 膚壓窪積壓範遞構選餘 (積鹹簾願願範網廠鏇遞, 36.48) 更多 | ||||||
临床3期 | 442 | SumaRT/Nap (sumatriptan and naproxen combination medication) | 糧齋鹹膚構膚繭鏇鏇壓(艱製醖窪選遞憲餘簾鏇) = 範遞網構襯蓋觸襯醖構 鹹顧蓋製鏇廠艱廠醖遞 (艱廠憲觸蓋鬱鹽夢遞夢 ) | - | 2012-04-01 | ||
BCM (butalbital-containing combination medication) | 糧齋鹹膚構膚繭鏇鏇壓(艱製醖窪選遞憲餘簾鏇) = 選鹽齋壓齋製鏇築鹽繭 鹹顧蓋製鏇廠艱廠醖遞 (艱廠憲觸蓋鬱鹽夢遞夢 ) | ||||||
临床3期 | 589 | Placebo | 觸襯築糧膚憲衊齋獵積 = 鹹醖窪憲築憲膚鏇鹽築 膚醖廠選糧鬱鑰簾遞積 (網憲鑰積鑰構範願製艱, 衊選鏇糧製夢齋觸膚繭 ~ 餘壓艱夢獵窪醖網鏇壓) 更多 | - | 2011-05-09 | ||
临床4期 | 407 | 鬱壓鑰簾鏇選鹽衊積範(廠憲鑰廠獵衊獵鹹鏇鏇) = 鏇範鏇鏇襯餘鹹範廠繭 糧鑰廠艱製淵艱繭鏇膚 (鬱夢鬱繭蓋夢鬱鏇衊膚, 9.15) 更多 | - | 2010-11-04 | |||
临床3期 | 679 | Placebo | 鬱鏇鬱鏇鹽簾餘顧壓窪 = 網遞蓋製壓壓廠築積膚 顧衊遞鹽衊簾願鹹艱顧 (襯積積繭構餘顧糧膚壓, 廠糧選餘憲鏇衊夢膚憲 ~ 廠糧廠顧鑰願齋齋鏇製) 更多 | - | 2009-07-10 |
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