更新于：2024-12-14
Flurbiprofen Sodium
氟比洛芬钠
更新于：2024-12-14
概要
基本信息
在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (1986-12-31), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C15H13FNaO2 |
InChIKeyCGCMNXTUJNJYIY-UHFFFAOYSA-N |
CAS号56767-76-1 |
关联
2
项与 氟比洛芬钠 相关的临床试验Pain-relieving plaster versus flurbiprofen cataplasms in terms of pain, stiffness, functional activities, joint swelling, quality of life, and safety for knee osteoarthritis treatment: a multi-center, randomized, controlled, non-inferiority clinical trial.
评估受试制剂氟比洛芬凝胶贴膏（规格：40mg）与参比制剂（泽普思® ）（规格：40mg）在健康成年受试者外用条件下的单中心、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 氟比洛芬钠 相关的临床结果
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100 项与 氟比洛芬钠 相关的转化医学
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100 项与 氟比洛芬钠 相关的专利（医药）
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48
项与 氟比洛芬钠 相关的文献（医药）2024-06-01European Review for Medical and Pharmacological Sciences
Efficacy and safety of topical NSAIDs combined with physiotherapy for frozen shoulder: a randomized controlled trial.
Article
作者: Li, H ; Zhou, C-Q ; Chen, G-Y ; Mao, X-Z
OBJECTIVE:
Frozen shoulder is a prevalent condition among individuals in their middle and later years. Invasive therapy has shown promising results in the treatment of frozen shoulders, but its widespread adoption has been hampered by high costs and the need for advanced medical technology. As a result, patients with frozen shoulders often turn to non-steroidal anti-inflammatory drugs (NSAIDs) for symptomatic relief. However, the oral administration of NSAIDs can lead to troublesome adverse effects on the gastrointestinal, cardiovascular, and urinary systems. In contrast, topical NSAIDs have gained attention for their excellent efficacy and lower adverse effects in various chronic pain conditions. Therefore, our study aimed to investigate the efficacy and safety of topical NSAIDs in improving pain and mobility among patients with frozen shoulders.
PATIENTS AND METHODS:
A total of 108 patients experiencing moderate to severe pain and mobility impairment due to frozen shoulder were enrolled in this study. The participants were randomly assigned to either the experimental group (n=72) or the control group (n=36). The experimental group received daily treatment with the loxoprofen hydrogel patch (LOX-P) in addition to basic rehabilitation physiotherapy. The control group was treated with flurbiprofen cataplasm (FLU-C) twice a day, along with rehabilitation physiotherapy. The primary endpoint for evaluating the efficacy of the two patches was the Constant-Murley score (CMS). Clinical symptom data, adverse events, and patient satisfaction were also recorded.
RESULTS:
After 14 days of treatment, the effective rate was 66.67% (n=48) in the experimental group and 41.67% (n=15) in the control group. The overall difference in the effective rates was 25.00% (95% CI=5.20-42.52; p=0.013). The safety profiles of the two topical agents were similar, with only a few adverse events reported.
CONCLUSIONS:
The loxoprofen hydrogel patch demonstrates a significant ability to alleviate shoulder pain and restore shoulder function in the treatment of frozen shoulder, with minimal adverse reactions. Chictr.org.cn ID: ChiCTR2100052375.
2024-05-01Pharmaceutical research
Nonlinear Pharmacokinetics of Topical Flurbiprofen Gel in a Phase I Study Among Chinese Healthy Adults
Article
作者: Xiao, Wending ; Cheng, Zeneng ; Xie, Feifan ; Zhu, Zhihong ; Liu, Feiyan
INTRODUCTION:
PDX-02 (Flurbiprofen sodium) is a topical nonsteroidal anti-inflammatory drug in gel formulation for local analgesia and anti-inflammation. A Phase I clinical trial was conducted to assess the safety, tolerability, and pharmacokinetics of single and multiple doses of PDX-02 gel in Chinese healthy adults.
METHODS:
The trial comprised three parts: (1) a single-dose ascending study with three dose levels (0.5%, 1% to 2% PDX-02 gel) applied on a 136 cm2 skin area; (2) a multiple-dose study with either 1% or 2% PDX-02 gel applied on a 136 cm2 skin area for 7 consecutive days; and (3) a high dose group with 2% PDX-02 gel on an 816 cm2 skin area and a frequent multiple dose group with 2% PDX-02 gel on a 272 cm2 skin area four times a day for 7 consecutive days. The safety, tolerability and pharmacokinetics of the PDX-02 gel were evaluated in each part.
RESULTS:
A total of sixty participants completed the trial, with all adverse events recovered and all positive skin reaction being transient and recovered. The overall absorption of topical PDX-02 gel was slow with a mean peak time exceeding 9 h. The elimination rate remained consistent between dose groups. A less-than-dose-proportional nonlinear pharmacokinetics relationship was observed within the studied dose range, and this is likely due to the autoinduction of skin first-pass metabolism.
CONCLUSION:
The topical PDX-02 gel showed favorable safety and tolerability in both single and multiple dosing studies, with a less-than-dose-proportional nonlinear pharmacokinetics observed.
2023-09-20Chinese medical journal
Efficacy and safety of flurbiprofen cataplasms versus loxoprofen sodium cataplasms in knee osteoarthritis: a randomized controlled trial
Article
作者: Guan, Zhenpeng ; Wang, Zhanguo ; Zhai, Suodi ; Yuan, Ping ; Xue, Tao ; Liu, Jiabang ; Wu, Ziyang ; Zhang, Hui ; Li, Dong ; Zhang, Guangwu ; Cheng, Yinchu ; Zhang, Kun ; Jia, Junxiu ; Kan, Jinfu
Abstract:
Background::
Clinical trial evidence is limited to identify better topical non-steroidal anti-inflammatory drugs (NSAIDs) for treating knee osteoarthritis (OA). We aimed to compare the clinical efficacy and safety of flurbiprofen cataplasms (FPC) with loxoprofen sodium cataplasms (LSC) in treating patients with knee OA.
Methods::
This is an open-label, non-inferiority randomized controlled trial conducted at Peking University Shougang Hospital. Overall, 250 patients with knee OA admitted from October 2021 to April 2022 were randomly assigned to FPC and LSC treatment groups in a 1:1 ratio. Both medications were administered to patients for 28 days. The primary outcome was the change of pain measured by visual analog scale (VAS) score from baseline to day 28 (range, 0–10 points; higher score indicates worse pain; non-inferiority margin: 1 point; superiority margin: 0 point). There were four secondary outcomes, including the extent of pain relief, the change trends of VAS scores, joint function scores measured by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and adverse events.
Results::
Among 250 randomized patients (One patient without complete baseline record in the flurbiprofen cataplasms was excluded; age, 62.8 ± 10.5 years; 61.4% [153/249] women), 234 (93.6%) finally completed the trial. In the intention-to-treat analysis, the decline of the VAS score for the 24-h most intense pain in the FPC group was non-inferior, and also superior to that in the LSC group (differences and 95% confidence interval, 0.414 (0.147–0.681); P <0.001 for non-inferiority; P = 0.001 for superiority). Similar results were observed of the VAS scores for the current pain and pain during exercise. WOMAC scores were also lower in the FPC group at week 4 (12.50 [8.00–22.50] vs. 16.00 [11.00–27.00], P = 0.010), mainly driven by the dimension of daily activity difficulty. In addition, the FPC group experienced a significantly lower incidence of adverse events (5.6% [7/124] vs. 33.6% [42/125], P <0.001), including irritation, rash and pain of the skin, and sticky hair uncovering pain.
Conclusions::
This study suggested that FPC is superior to LSC for treating patients with knee OA in pain relief, joint function improvement, and safety profile.
100 项与 氟比洛芬钠 相关的药物交易
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 强直性脊柱炎 | 中国 | 1998-01-01 | |
| 骨关节炎 | 中国 | 1998-01-01 | |
| 疼痛 | 中国 | 1998-01-01 | |
| 类风湿关节炎 | 中国 | 1998-01-01 | |
| 瞳孔缩小 | 美国 | 1986-12-31 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 膝关节炎 | 临床3期 | 中国 | 2020-03-31 | |
| 膝关节炎 | 临床3期 | 中国 | 2020-03-31 |
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