Multimodal analgesia (MMA) is an essential part of Enhanced Recovery After Surgery (ERAS) protocol. The principle of MMA is to manage pain with analgesics of multiple classes acting on distinct target sites through different strategies. MMA can reduce the adverse reaction caused by opioids and improve the quality of recovery from surgery. Inadequate postoperative pain management will increase the risk of complications, including pneumonia, deep vein thrombosis, infection, delayed surgical healing, and chronic postoperative pain.

开始日期2024-05-31

申办/合作机构

中国医药大学附设医院

NCT06344169 / Not yet recruiting临床2/3期IIT

Efficacy of Parenteral Injection of an Extended Release Kappa-receptor Opioid Sebacoyl Dinalbuphine Ester for Pain Management After Cesarean Section: a Randomized, Open-label, Non-inferiority Trial

Inadequate postoperative pain management can lead to physical and psychological distress in patients as well as impact surgical wound healing and increase the risk of developing postoperative delirium and cardiopulmonary and thromboembolic events. Severe postoperative pain may also result in the development of chronic post-surgical pain (CPSP), which in turn can lead to prolonged use of opioids and increased health-care costs. A descriptive survey study in 60 postpartum women who received cesarean section suggested that the presence of postoperative pain significantly reduced the willingness of breastfeeding and infant care. The incidence of CPSP after cesarean delivery has been reported to vary from 1% to 18% up to 1 year after operation. Intrathecal morphine (ITM) injection is considered as the standard pain management strategy for post-cesarean pain. However, the overall analgesic effect of ITM is about 8-12h and it is associated with pruritus, nausea/vomiting, urinary retention, constipation, mental status change, and respiratory depression. Therefore, the development of a safe, conveniently operated, and long-lasting analgesic strategy, which serves as background pain control modality up to several days after cesarean section should provide clinically beneficial advantages in the management of acute postoperative pain and prevention of CPSP in postpartum women. Naldebain® is prodrug of nalbuphine, which was approved by the Taiwan FDA in 2017. Naldebain® is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine. The bioavailability of nalbuphine following intramuscular injection Naldebain® was 85.4%, and it took approximately 6 days for the complete release of Naldebain® into the blood circulation. Therefore, a single parenteral injection of Naldebain® could provide long lasting analgesic effect in several phase II trials. However, Naldebain® has not been tested in the pain control after cesarean section. Therefore, this PI-initiated prospective, randomized, open-label, non-inferiority trial aims to investigate the clinical efficacy of Naldebain® in management of acute postoperative pain in term parturient who receive elective cesarean section to provide analgesic effect that is not inferior to the standard ITM and prevent the development of CPSP.

开始日期2024-04-15

申办/合作机构-

NCT05842733 / Enrolling by invitation临床2期

A Novel, Potent and Non-addictive Analgesic of Combinations for Knee Replacement Moderate to Severe Pain Management

To assess the safety, efficacy, and pharmacokinetics of oral SafeTynadol, Naldebain and Naldebain combine with SafeTynadol in the treatment of moderate to severe pain following knee replacement.

开始日期2023-07-25

申办/合作机构

欣耀生医股份有限公司

100 项与那布扶林相关的临床结果

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100 项与那布扶林相关的转化医学

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100 项与那布扶林相关的专利（医药）

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项与那布扶林相关的文献（医药）

2024-06-01·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Amphiphilic NLC-Gel formulation loaded with Sebacoyl dinalbuphine ester and Nalbuphine for localized postoperative pain management

Article

作者: Shyong, Yan-Jye ; Li, Yi-Lian ; Kuo, Cheng-Hsiang ; Tsai, Jui-Chen ; Tu, Ting-Yuan ; Chen, Yu-Wei ; Lin, Cheng-Li ; Liu, Yuan-Fu

Opioids are powerful analgesics; however, their significant systemic adverse effects and the need for frequent administration restrict their use. Nalbuphine (NA) is a κ-agonist narcotic with limited adverse effects, but needs to be frequently administrated due to its short elimination half-life. Whereas sebacoyl dinalbuphine ester (SDE) is a NA prodrug, which can effectively prolong the analgesic effect, but lacks immediate pain relief. Therefore, in this study, a rapid and sustained local delivery formulation to introduce NA and SDE directly into surgical sites was developed. An amphiphilic nanostructured lipid carrier (NLC) poloxamer 407 (P407) gel (NLC-Gel) was developed to permit concurrent delivery of hydrophobic SDE from the NLC core and hydrophilic NA from P407, offering a dual rapid and prolonged analgesic effect. Benefiting from the thermal-sensitive characteristic of P407, the formulation can be injected in liquid phase and instantly transit into gel at wound site. NLC-Gel properties, including particle size, drug release, rheology, and stability, were assessed. In vivo evaluation using a rat spinal surgery model highlighted the effect of the formulation through pain behavior test and hematology analysis. NLC-Gels demonstrated an analgesic effect comparable with that of commercial intramuscular injected SDE formulation (IM SDE), with only 15 % of the drug dosage. The inclusion of supplemental NA in the exterior gel (PA12-Gel + NA) provided rapid drug onset owing to swift NA dispersion, addressing acute pain within hours along with prolonged analgesic effects. Our findings suggest that this amphiphilic formulation significantly enhanced postoperative pain management in terms of safety and efficacy.

2024-06-01·Journal of clinical pharmacology

Breast Milk Excretion of Dinalbuphine Sebacate Injection Administered After Cesarean Section

Article

作者: Hsiao, Wen‐Kai ; Wang, Kai‐Yi ; Lin, Chi‐Kang ; Tang, Sung‐Ling

Abstract:

Ensuring the safety of analgesics during lactation is crucial for women of childbearing potential. Available data regarding the transfer of nalbuphine for postoperative acute pain via breast milk are limited to the postmarketing experience. This lactation study aimed to assess nalbuphine and dinalbuphine sebacate concentrations in breast milk from lactating women with postoperative pain treated with dinalbuphine sebacate extended‐release injection (150 mg dinalbuphine sebacate/2 mL Naldebain). Breast milk was collected throughout the 5‐day posthospitalization interval from 20 mothers injected with one dose of extended‐release dinalbuphine sebacate intramuscularly. Maternal safety was assessed during the study period. Nalbuphine was detectable in 71% of milk samples collected from all mothers, whereas dinalbuphine sebacate was undetectable or below the quantitation limit (0.1 ng/mL). The mean nalbuphine concentration in milk was approximately 10.55 ng/mL, with the peak concentration reaching up to 12.7 ng/mL. The mean relative infant dose was 0.39% (coefficient of variation, 65%). The mean pain intensity at rest was reduced to mild pain from Day 2 morning to discharge. Overall, the maternal safety profile was tolerable. The breast milk of women who receive one dose of dinalbuphine sebacate injection postpartum contains low nalbuphine concentration. In addition, dinalbuphine sebacate injection potentially reduces maternal pain intensity during the first postpartum week and offers low toxicity risk among breastfed infants.

2024-05-17·AQUACULTURE NUTRITION

Effect of Scoparia dulcis Extract on Lipid Oxidation in Fish Feed, Growth Performance, and Hypoxia Tolerance in Juvenile Jian Carp (Cyprinus carpio var. Jian)

Article

作者: Ye, Yuxue ; He, Mingquan ; Liao, Ling ; Li, Fengyi ; Du, Wenhao ; Li, Huatao ; Wu, Min ; Xu, Jing ; Yu, Xiaolu ; Chen, Gangfu

Lipid oxidation and hypoxia can lead to oxidative damage in aquatic animals. This study explored the effects of Scoparia dulcis extracts (SDE) on lipid oxidation, fish growth performance, digestive ability, antioxidant capacity, and hypoxia tolerance ability. The results showed that SDE decreased malonaldehyde (MDA), conjugated diene (CD), and peroxide value (PO) in the linoleic acid and linolenic acid as well as in fish feed. Broken-line analysis revealed that the optimal acetone extract of S. dulcis (AE) supplements was 4.02, 4.01, and 4.01 g kg−1 determined from PO, CD, and MDA, respectively. Dietary AE supplementation increased feed intake and specific growth rate and activities of amylase, trypsin, and lipase as well as alkaline phosphatase in fish hepatopancreas and gut. Polynomial regression analysis showed that optimal dietary AE supplement was 3.61 g kg−1 diet determined from weight gain. Furthermore, dietary AE supplementation decreased MDA content and increased glutathione content and the activities of glutathione peroxidase, catalase, superoxide dismutase, and glutathione reductase in fish digestive organs, gills, erythrocytes, and muscle. Dietary AE supplementation increased durative time (DT) and oxygen consumption rate (OCR) under hypoxia condition. Based on polynomial regression analysis, optimal dietary AE supplements were 4.73 and 4.60 g kg−1 diet determined from DT and OCR for hypoxia tolerance in fish, respectively. According to our current research, SDE’s antioxidant capacity may be attribute to their phenolic chemicals.

项与那布扶林相关的新闻（医药）

2022-10-16

·E药经理人

中国台湾Top10 Biotech盘点：遍地开花，专注植物药、单克隆抗体药物、疫苗研发……

中国台湾生物技术公司正蓬勃发展。多年来，中国台湾方面采取积极主动的姿态，通过监管和促进政策，推进和引导生物科技产业。自1980年代以来，当地政府一直在投资该行业，并于1984年成立了旨在推动中国台湾生物技术和制药业的非营利组织生物技术发展中心。在政策扶持等各方润土下，中国台湾创新生物科技公司逐步在世界赢得一席之地。知名外媒Labiotech统计了中国台湾10家创新生物科技公司，领域分别聚焦于植物药、单克隆抗体(mAb)药物、癌症细胞免疫疗法、人用疫苗、小分子药物等。总的来看，这些Biotech成立时间跨度较大，但大多集中于2000年前后。其中，历史最为悠久的是成立于1965年的老牌企业Adimmune，发展至今已有50多年历史，专注于人用疫苗的研发、加工、制造和销售。而最年轻的Biotech至今也已发展5年，为2017年成立的Acepodia。在这10家企业中，总部一半坐落在台北。在2021年，中国台湾生物科技公司营收也创下新高，创造了超过7000亿新台币（233.7亿美元）的收入，比2020年增长了近10%。以下是中国台湾涉及应用生物技术和制药领域的10家生物技术公司（排名不分先后）：1.TailMed Biologics地点：台北成立时间：2007TailMed Biologics是单克隆抗体(mAb)药物的开发商和制造商，并提供CDMO服务。该公司由著名的艾滋病研究人员David Ho创立。2007年，基因泰克将用于治疗HIV/AIDS的单克隆抗体Trogarzo(ibalizumab)授权给TailMed，以完成该药物的开发。2018年和2019年，ibalizumab分别获得美国食品药品监督管理局（FDA）和欧洲药品管理局的批准。TailMed目前正在研究ibalizumab的其他给药途径，这些新技术可以克服ibalizumab耐药性和广泛中和HIV-1抗体。2. PhytoHealth Corp.地点：台北成立时间：1998PhytoHealth是第一家在中国台湾股票市场上市的药物开发公司。该公司专注于开发植物药——以中药为基础的草药化合物。2010年，中国台湾批准了PhytoHealth的抗癌疲劳植物药，这是一种从开花植物黄芪中分离出来的冷冻干燥碳水化合物分子的注射剂。该药物已被美国FDA授予用于特发性血小板减少性紫癜的孤儿药指定——一种血液中血小板数量异常低的血液疾病。此外，PhytoHealth还有其它几款正在开发的候选药物，其中三个已经完成了3期临床试验，并已获得美国FDA快速通道指定。3.Lumosa Therapeutics地点：台北成立时间：2000Lumosa Therapeutics是一家临床阶段的公司，为神经和肿瘤疾病开发解决方案。该公司首个上市产品Naldebain是世界上第一个用于术后疼痛的镇痛剂注射剂，可提供长达7天的持续镇痛作用，同时绕过与阿片类药物相关的物质依赖。其产品管线中的另一种产品为由合成肽和抗氧化剂组成的新型分子，它可以恢复阻塞的血流而不会导致出血，用于治疗急性缺血性中风，这是一项未得到满足的医疗需求，因为由于出血风险增加，美国FDA批准的唯一一种缺血性卒中治疗仅限于卒中发病3-4.5小时内的患者，使得该药物在临床上的实际使用率仅为1-8%。4. AltruBio地点：台北成立时间：2001AltruBio正开发一种免疫调节剂，用于治疗和预防炎症和自身免疫性疾病。该公司最先进的项目neihulizumab是一种一流的抗体，具有独特的作用机制：它选择性地靶向并消耗参与免疫介导疾病的慢性活化T细胞，保持其他T细胞完整以维持宿主防御。Neihulizumab在银屑病关节炎和溃疡性结肠炎的2a期试验中显示出临床疗效，目前正处于急性移植物抗宿主病的1期试验中。另一种T细胞调节剂正处于临床前开发阶段，可作为实体器官移植后长期给予免疫抑制药物的替代方案。5.ScinoPharm Taiwan地点：台南成立时间：1997ScinoPharm是一家全球性的活性药物成分(API)制造商，从事其研究、开发、制造和销售。除了作为全球制药行业的主要原料药供应商外，该公司还提供外包服务，供应的主要产品包括抗癌原料药、蛋白质药物、多肽、新型小分子药物和注射剂。6. Acepodia地点：新北市成立时间：2017Acepodia专注于使用其专有的抗体细胞偶联（ACC）平台开发下一代癌症细胞免疫疗法。ACC是一种肿瘤靶向技术，可简单且经济有效地将抗体直接连接到γ-δ(γδ)T细胞和自然杀伤(NK)细胞，以增强其肿瘤杀伤能力，而无需进行基因操作。该公司管道中最先进的产品是一种现成的ACC-oNK细胞疗法，与HER2抗体结合，用于治疗表达HER2的肿瘤，目前处于第一阶段测试中。7. Caliway Biopharmaceuticals地点：新北市成立时间：2012Caliway Biopharmaceuticals主要开发用于治疗和美容目的的新型小分子药物。旗下重要候选产品是一款可以破坏注射部位脂肪细胞的注射剂，该药物已经完成了非手术减脂的2a期测试，预计其适应症将扩展到Dercum病和脂肪瘤（这两种疾病都是脂肪组织块在皮肤下生长的疾病）。临床开发中的其他产品主要针对骨关节炎、糖尿病以及皮肤色素沉着过度和衰老。8. Adimmune Corp.地点：台中成立时间：1965Adimmune是本次中国台湾生物技术公司名单中历史最悠久的公司，专注于人用疫苗的研发、加工、制造和销售。它是亚洲唯一一家同时拥有欧盟良好生产规范和美国FDA认证的流感疫苗制造商。除了在国内供应超过3000万剂流感疫苗外，Adimmune还向国际市场扩张：其针对四种不同抗原的四价流感疫苗在赛诺菲的帮助下于美国实现商业化，并在美国完成了3期试验。其他产品包括破伤风、日本脑炎疫苗以及针对肠道病毒71的疫苗等。Adimmune还在开发用于大规模生产DNA的质粒生产平台，以满足对DNA和RNA疗法不断增长的需求。9. Steminent Biotherapeutics地点：台北成立时间：2009Steminent是一家干细胞研发公司，在其Stemchymal产品组合下开发新型细胞疗法。Stemchymal产品由从人类供体来源的脂肪组织中分离出来的干细胞制成。Steminent最先进的细胞疗法正处于治疗脊髓小脑性共济失调的第二阶段测试中——这是一种罕见的神经退行性疾病，会导致协调性进行性困难。除了急性肝功能衰竭和药物性肝损伤的临床前阶段项目外，其他疗法还包括治疗1期膝关节骨性关节炎的候选药物。10. United BioPharma地点：新竹成立时间：2013United BioPharma专注于开发用于治疗传染病、免疫疾病和癌症的创新单克隆抗体。旗下主要候选药物是一种单克隆抗体，正在研究用于2期和3期试验中三种不同的HIV适应症。其余正在进行临床试验的候选药物包括用于治疗复发性生殖器疱疹和慢性自发性荨麻疹的单克隆抗体。该公司还拥有三种用于乳腺癌、胃癌和慢性淋巴细胞白血病临床前开发的单克隆抗体。参考来源：《10 biotech companies to know in Taiwan》https://www.labiotech.eu/best-biotech/10-biotech-companies-taiwan/登记邮箱信息订阅E药经理人信息服务扫描二维码精彩推荐集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

抗体疫苗细胞疗法免疫疗法小分子药物

2017-11-13

·BioPortfolio

Lumosa Therapeutics Co Ltd 6535 Financial and Strategic SWOT Analysis Review [Report Updated: 13112017] Prices from USD $300

Summary Lumosa Therapeutics Co Ltd Lumosa Therapeutics, formerly SunTen Phytotech Co Ltd is a developer of neurological and inflammatory drugs. The company's pipeline products comprise LT1001 for moderate to severe pain, LT2001 for tumor and cancer and LT3001 for acute ischemic stroke. Its activities comprise translational research, preclinical, intellectual property regulatory affairs, clinical development, project management and business development. Lumosa Therapeutics' products are used in the areas of neural, hypertension, diabetic foot ulcer, oncology and inflammatory diseases. The company partners with biotech and pharmaceutical companies for product licensing, development and commercialization. Lumosa Therapeutics is headquartered in Taipei, Taiwan. This comprehensive SWOT profile of Lumosa Therapeutics Co Ltd provides you an indepth strategic analysis of the company's businesses and operations. The profile has been compiled by GlobalData to bring to you a clear and an unbiased view of the company's key strengths and weaknesses and the potential opportunities and threats. The profile helps you formulate strategies that augment your business by enabling you to understand your partners, customers and competitors better. This company report forms part of GlobalData's Profile on Demand' service, covering over 50,000 of the world's leading companies. Once purchased, GlobalData's highly qualified team of company analysts will comprehensively research and author a full financial and strategic analysis of Lumosa Therapeutics Co Ltd including a detailed SWOT analysis, and deliver this direct to you in pdf format within two business days. excluding weekends. The profile contains critical company information including*, Business description A detailed description of the company's operations and business divisions. Corporate strategy Analyst's summarization of the company's business strategy. SWOT Analysis A detailed analysis of the company's strengths, weakness, opportunities and threats. Company history Progression of key events associated with the company. Major products and services A list of major products, services and brands of the company. Key competitors A list of key competitors to the company. Key employees A list of the key executives of the company. Executive biographies A brief summary of the executives' employment history. Key operational heads A list of personnel heading key departments/functions. Important locations and subsidiaries A list and contact details of key locations and subsidiaries of the company. Key manufacturing facilities A list of key manufacturing facilities of the company. Detailed financial ratios for the past five years The latest financial ratios derived from the annual financial statements published by the company with 5 years history. Interim ratios for the last five interim periods The latest financial ratios derived from the quarterly/semiannual financial statements published by the company for 5 interims history. Note*: Some sections may be missing if data is unavailable for the company. Key benefits of buying this profile include, You get detailed information about the company and its operations to identify potential customers and suppliers. The profile analyzes the company's business structure, operations, major products and services, prospects, locations and subsidiaries, key executives and their biographies and key competitors. Understand and respond to your competitors' business structure and strategies, and capitalize on their weaknesses. Stay up to date on the major developments affecting the company. The company's core strengths and weaknesses and areas of development or decline are analyzed and presented in the profile objectively. Recent developments in the company covered in the profile help you track important events. Equip yourself with information that enables you to sharpen your strategies and transform your operations profitably. Opportunities that the company can explore and exploit are sized up and its growth potential assessed in the profile. Competitive and/or technological threats are highlighted. Scout for potential investments and acquisition targets, with detailed insight into the companies' strategic, financial and operational performance. Financial ratio presented for major public companies in the profile include the revenue trends, profitability, growth, margins and returns, liquidity and leverage, financial position and efficiency ratios. Gain key insights into the company for academic or business research. Key elements such as SWOT analysis, corporate strategy and financial ratios and charts are incorporated in the profile to assist your academic or business research needs.

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外链

KEGG	Wiki	ATC	Drug Bank
-	那布扶林	N02AF02	DB15341

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
疼痛	中国台湾	台耀化学股份有限公司	2016-07-11

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适应症	最高研发状态	国家/地区	公司	日期
镇痛	临床3期	中国	顺天医药生技股份有限公司	2021-06-04
镇痛	临床3期	中国	联亚药业股份有限公司	2021-06-04
镇痛	临床3期	中国	上海新探创业投资有限公司	2021-06-04
中度疼痛	临床3期	中国	顺天医药生技股份有限公司	2021-06-04
中度疼痛	临床3期	中国	上海新探创业投资有限公司	2021-06-04
中度疼痛	临床3期	中国	联亚药业股份有限公司	2021-06-04
重度疼痛	临床3期	中国	顺天医药生技股份有限公司	2021-06-04
重度疼痛	临床3期	中国	上海新探创业投资有限公司	2021-06-04
重度疼痛	临床3期	中国	联亚药业股份有限公司	2021-06-04
感觉迟钝	临床3期	中国台湾	顺天医药生技股份有限公司	2012-12-01