更新于：2024-05-03

Ibuprofen

布洛芬

更新于：2024-05-03

概要

概要

基本信息

简介布洛芬是一种小分子药物，具有 COX 抑制剂的作用。强生公司于 1978 年 8 月批准了该药，主要用于治疗类风湿性关节炎、关节炎、发烧和疼痛等疾病。布洛芬会阻碍产生前列腺素的 COX 酶的活性。这些激素参与炎症和疼痛信号传导。通过减少前列腺素的产生，布洛芬可以减轻炎症并减轻疼痛。多种形式的布洛芬可在柜台购买，包括片剂、胶囊和外用乳膏。虽然布洛芬通常是安全的，但长期使用或高剂量使用会增加胃肠道出血、肾脏损伤和心脏问题等副作用的风险。患者应遵守推荐剂量，如果症状持续或恶化，应寻求医疗建议。

药物类型

小分子化药

别名

(4-isobutylphenyl)-α-methylacetic acid、(RS)-ibuprofen、(±)-2-(p-isobutylphenyl)propionic acid

+ [86]

靶点

COX

作用机制

COX抑制剂(环氧化酶抑制剂)

治疗领域

免疫系统疾病神经系统疾病心血管疾病+ [6]

在研适应症

动脉导管未闭慢性疼痛幼年型关节炎+ [26]

非在研适应症

急性疼痛急性呼吸道感染镇痛+ [10]

原研机构

Johnson & Johnson

在研机构

Kaken Pharmaceutical Co., Ltd.Viatris Pty Ltd.

先声药业有限公司

+ [15]

非在研机构

海南正瑞医药科技开发有限公司

Apsen Farmacêutica SA

Pfizer Inc.

+ [13]

最高研发阶段批准上市

首次获批日期

中国 (1966-01-01),

关节炎发热疼痛

最高研发阶段(中国)批准上市

特殊审评优先审评 (中国)

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结构

分子式C13H18O2

InChIKeyHEFNNWSXXWATRW-UHFFFAOYSA-N

CAS号15687-27-1

关联

1,000

项与布洛芬相关的临床试验

CTRI/2024/03/064923 / Not yet recruiting临床4期

Effectiveness of oral premedication on anesthetic success of Inferior alveolar nerve block in mandibular molars with symptomatic irreversible pulpitis using Dexamethasone and combination of Dexamethasone and Ibuprofen A double blinded randomized controlled trial - NIL

开始日期2024-04-25

申办/合作机构-

NCT06342830 / Not yet recruiting临床2期IIT

Comparison of the Effects of Different Natural and Synthetic Intracanal Medicaments on the Healing of Periapical Lesion in Retreatment Cases (A Randomized Clinical Trial)

The goal of this clinical trial is to compare the effects of different intracanal medication between endodontic retreatment visits in previously failed root canal treatment patients (single root canal anteriors or premolars teeth). The main question it aims to answer are:
Is natural and synthetic intracanal Medicament effective in reducing or complete healing of Periapical lesions or not? the researchers will compare the effect of different intracanal dressing including:
nanocurcumin gel
curcumin gel
ciprofloxacin +ibuprofen gel
calcium hydroxide Paste as control group in between the endodontic retreatment visits to see if these medicaments work well on periapical lesion healing this outcome measured by Cone beam CT at base and after 6 months follow up periods

开始日期2024-04-01

申办/合作机构

Ain Shams University

NCT06088732 / Recruiting临床1/2期IIT

Effects of Acute Exercise and Ibuprofen on Symptoms, Immunity, and Neural Circuits in Bipolar Depression

This is a 2x2, within-subjects, cross-over trial to test the anti-depressant effects of acute exercise in 20 participants with bipolar depression. Participants will complete four experimental sessions, two with an exercise challenge and two with a resting control condition in a counterbalanced order. Participants will receive either 800mg of ibuprofen or placebo before exercise or rest in order to test whether blocking the inflammatory response to exercise interferes with the neural and psychological effects of exercise.

开始日期2024-03-12

申办/合作机构

Laureate Institute for Brain Research

100 项与布洛芬相关的临床结果

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100 项与布洛芬相关的转化医学

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100 项与布洛芬相关的专利（医药）

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15,987

项与布洛芬相关的文献（医药）

2024-12-31·Journal of the International Society of Sports Nutrition

The dose-response effects of flurbiprofen, indomethacin, ibuprofen, and naproxen on primary skeletal muscle cells

Article

作者: Roberts, Brandon M ; Matheny, Ronald W ; Geddis, Alyssa V

BACKGROUND:

Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, flurbiprofen, naproxen sodium, and indomethacin are commonly employed for their pain-relieving and inflammation-reducing qualities. NSAIDs work by blocking COX-1 and/or COX-2, enzymes which play roles in inflammation, fever, and pain. The main difference among NSAIDs lies in their affinity to these enzymes, which in turn, influences prostaglandin secretion, and skeletal muscle growth and regeneration. The current study investigated the effects of NSAIDs on human skeletal muscle cells, focusing on myoblast proliferation, differentiation, and muscle protein synthesis signaling.

METHODS:

Using human primary muscle cells, we examined the dose-response impact of flurbiprofen (25-200 µM), indomethacin (25-200 µM), ibuprofen (25-200 µM), and naproxen sodium (25-200 µM), on myoblast viability, myotube area, fusion, and prostaglandin production.

RESULTS:

We found that supraphysiological concentrations of indomethacin inhibited myoblast proliferation (-74 ± 2% with 200 µM; -53 ± 3% with 100 µM; both p < 0.05) compared to control cells and impaired protein synthesis signaling pathways in myotubes, but only attenuated myotube fusion at the highest concentrations (-18 ± 2% with 200 µM, p < 0.05) compared to control myotubes. On the other hand, ibuprofen had no such effects. Naproxen sodium only increased cell proliferation at low concentrations (+36 ± 2% with 25 µM, p < 0.05), and flurbiprofen exhibited divergent impacts depending on the concentration whereby low concentrations improved cell proliferation (+17 ± 1% with 25 µM, p < 0.05) but high concentrations inhibited cell proliferation (-32 ± 1% with 200 µM, p < 0.05).

CONCLUSION:

Our findings suggest that indomethacin, at high concentrations, may detrimentally affect myoblast proliferation and differentiation via an AKT-dependent mechanism, and thus provide new understanding of NSAIDs' effects on skeletal muscle cell development.

2024-05-01·Journal of Clinical Anesthesia

Femoral vs sciatic nerve block to provide analgesia after medial open wedge high tibial osteotomy in the setting of multimodal analgesia: A randomized, controlled, single-blinded trial

Article

作者: Rossel, Jean-Benoit ; Nguyen, Alexandre ; Albrecht, Eric ; Martin, Robin ; Kull, Corey

STUDY OBJECTIVE:

Medial open wedge high tibial osteotomy (MOW HTO) is associated with moderate to severe postoperative pain. The proximal part of the tibia is innervated by branches from the femoral nerve anteriorly and the sciatic nerve posteriorly. There is a paucity of information regarding the optimal peripheral nerve block for postoperative analgesia with minimal impact on motor function. This study tested the hypothesis that a femoral nerve block provides superior analgesia to a sciatic nerve block after MOW HTO in the setting of multimodal analgesia.

DESIGN:

Randomized controlled single-blind trial.

SETTING:

Operating room, postoperative recovery area and ward, up to 6 postoperative months.

PATIENTS:

Fifty patients undergoing MOW HTO.

INTERVENTIONS:

Interventions were femoral or sciatic nerve block under ultrasound guidance. For each intervention, a total of 100 mg of ropivacaine was injected. Postoperative pain treatment followed a pre-defined protocol with intravenous patient-controlled analgesia of morphine, paracetamol, and ibuprofen.

MEASUREMENTS:

The primary outcome was intravenous morphine consumption at 24 h postoperatively. Secondary outcomes included rest and dynamic pain scores (on a numeric rating scale out of 10) at 2, 24 and 48 h postoperatively. Functional outcomes included the Short Form-12, Knee injury and Osteoarthritis Outcome Score, and International Knee Documentation Committee (IKDC) scores measured at 6 months postoperatively.

MAIN RESULTS:

Mean [95% confidence interval] i.v. morphine consumption at 24 postoperative hours were 24 mg [15 mg,33 mg] in the femoral nerve block group and 24 mg [16 mg,32 mg] in the sciatic nerve block group (p = 0.98). There were no significant differences in the secondary outcomes between groups.

CONCLUSIONS:

This trial failed to demonstrate that a femoral nerve block provides superior analgesia to a sciatic nerve block after MOW HTO under general anesthesia in the setting of multimodal analgesia. There was no significant difference in quality of life and functional outcomes at 6 months postoperatively between groups. Trial registry number:Clinicaltrials.com - NCT05728294; Kofam.ch - SNCTP000003048 | BASEC2018-01774.

2024-04-01·Archives of Oral Biology

Nociceptive and histomorphometric evaluation of the effects of ozone therapy on the rat masseter muscle in a carrageenan model of myofascial pain

Article

作者: Casais-E-Silva, Luciana Lyra ; da Silva Guerreiro, Marcos Lázaro ; Aguiar, Marcio Cajazeira ; de Souza, Kelvin Borges Rocha ; Almeida Guerra, Lysianne Rodrigues de

OBJECTIVE:

This study evaluated the effects of intramuscular ozone therapy on nociception, inflammation, and tissue damage caused by the injection of carrageenan in the masseter muscle of rats.

DESIGN:

Rat masseter muscles were injected with saline or carrageenan. Seventy-seven adult male rats were divided into six groups: Sal, saline; Car, carrageenan; Ibup + Sal, ibuprofen and saline; Ibup + Car, ibuprofen and carrageenan; O3 + Sal, ozone and saline; and O3 + Car, ozone and carrageenan. The mixture of 5% ozone and 95% oxygen (20 µg/mL) was administered three times in the course of a week. Nociceptive responses in the masseter muscles were measured using a head withdrawal threshold, determined by an electronic von Frey anesthesiometer. The animals were euthanized one or eight days after the carrageenan injection, and the masseters were submitted to histological and histomorphometric analyses.

RESULTS:

Mechanical allodynia and inflammation levels were reduced in the Ibup + Car group compared to the other groups. Myonecrosis was similar among carrageenan-treated groups. Picrosirius red stained sections showed more collagen fibers and more regenerating myofibers in the O3 + Car group compared to the other groups. Eight days after carrageenan injection, the O3 + Car group showed neutrophils close to the regenerating myofibers.

CONCLUSIONS:

Intramuscular ozone therapy did not alleviate mechanical allodynia, and it did not protect the masseter muscle against the deleterious effects produced by carrageenan, probably due to the mode of administration of this therapeutic agent.

558

项与布洛芬相关的新闻（医药）

2024-04-30

·PRNewswire

CUMBERLAND PHARMACEUTICALS TO ANNOUNCE FIRST QUARTER 2024 FINANCIAL RESULTS

NASHVILLE, Tenn., April 30, 2024 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, announced today that it will release its first quarter 2024 financial results and provide a company update after the market closes on Tuesday, May 7, 2024. A conference call will be held on May 7 at 4:30 p.m. Eastern Time to discuss the results. To participate in the call, please register at . Once registered, participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference. A replay of the call will be available for one year and can be accessed via Cumberland's website or by visiting . Cumberland Pharmaceuticals is a specialty pharmaceutical company focused on providing unique products that improve patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes: Acetadote® (acetylcysteine) injection, for the treatment of acetaminophen poisoning; Caldolor® (ibuprofen) injection, for the treatment of pain and fever; Kristalose® (lactulose) for oral solution, a prescription laxative, for the treatment of constipation; Omeclamox®-Pak, (omeprazole, clarithromycin, amoxicillin) for the treatment of Helicobacter pylori (H. pylori) infection and related duodenal ulcer disease; Sancuso® (granisetron) transdermal system, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; Vaprisol® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and Vibativ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections. The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy and Systemic Sclerosis. Additionally, Cumberland recently received FDA clearance to proceed directly to a Phase II study for patients with Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease. For more information on Cumberland's approved products, including full prescribing information, please visit links to the individual product websites, which can be found on the company's website at . SOURCE Cumberland Pharmaceuticals Inc.

临床2期上市批准财报

2024-04-25

·药研发

【药研发0426】常山生化GLP-1R激动剂报产 | 和誉肝癌新药获孤儿药资格...

「本文共：17条资讯，阅读时长约：3分钟」今日头条常山生化GLP-1R激动剂报产。河北常山生化药业旗下常山凯捷健生物提交的艾本那肽注射液上市申请获CDE受理，拟用于在饮食控制和运动基础上改善2型糖尿病患者的血糖控制。艾本那肽注射液是一款长效GLP-1受体激动剂，此前已在中国2型糖尿病患者中开展的III期临床研究中达到了主要终点和关键次要终点。患者接受艾本那肽注射液治疗24周后，其血糖水平显著降低，且疗效维持长达52周。国内药讯1.君实PD-1单抗在香港报产。君实生物PD-1抑制剂特瑞普利单抗向香港卫生署药物办公室（DO）提交上市申请并获得受理，拟联合顺铂/吉西他滨一线治疗转移性或复发性局部晚期鼻咽癌成人患者，以及单药治疗复发性、不可切除或转移性鼻咽癌。在Ⅲ期临床JUPITER-02中，特瑞普利单抗联合化疗使患者的疾病进展或死亡风险降低48%，死亡风险降低37%。2.科伦博泰ADC亮相ASCO。科伦博泰宣布将在ASCO2024年会上口头报告Trop2 ADC新药SKB264两项临床研究的最新数据。这两项临床分别为：SKB264用于治疗局部复发性或转移性三阴乳腺癌经治患者的Ⅲ期临床OptiTROP-Breast01；SKB264联合PD-L1单抗KL-A167一线治疗晚期非小细胞肺癌患者的Ⅱ期临床OptiTROP-Lung01。SKB264是科伦博泰采用专有毒素-连接子策略研发的一款创新ADC，抗体药物偶联比（DAR）平均值高达7.4。3.和誉肝癌新药获孤儿药资格。和誉医药自主研发的小分子FGFR4抑制剂依帕戈替尼（irpagratinib/ABSK011）获FDA授予孤儿药资格，用于治疗肝细胞癌（HCC）。在具有过表达FGF19的HCC细胞中，ABSK011可以通过抑制FGFR4的自身磷酸化并阻断FGFR4向下游通路活化的信号转导，最终抑制HCC患者的肿瘤。临床数据显示，ABSK011（每日两次）治疗的客观缓解率（ORR）达40.7%。4.康方双抗实体瘤早期临床积极。康方生物PD-1/VEGF双抗依沃西（AK112/SMT112）在治疗晚期实体瘤（包括卵巢浆液性癌、MSS结直肠癌和其他癌症）的Ⅰa期临床中获积极结果。中位随访为12.8个月时，依沃西在这类被认为对单药免疫治疗缺乏响应的肿瘤患者中达到了25.5%的客观缓解率（ORR），疾病控制率（DCR）为63.8%，且具有良好的安全性。详细数据已发表于《癌症免疫治疗杂志》（JITC）期刊上。5.通化东宝双靶点减肥药获批临床。通化东宝1类化药注射用THDBH120获国家药监局临床试验默示许可，拟开发用于超重/肥胖患者的长期体重管理。THDBH120是一款GLP-1/GIP双靶点激动剂，通过分子设计将GLP-1和GIP这两种促胰岛素的作用整合至一个多肽分子中，同时提高了代谢稳定性，从而改善血糖控制。去年年底，该新药已获批开展用于治疗2型糖尿病的临床研究。6.迈诺威病理性瘢痕新药获批IND。迈诺威医药拟用于预防和治疗病理性瘢痕的创新药MI151凝胶获FDA临床许可。MI151可抑制成纤维细胞增殖和TGF-β1的产生，同时可以影响TNF-α、IL-1β等炎症细胞因子和粘附分子的产生以及基质重塑因子的表达，有望通过抗炎和抗纤维化的双重作用来治疗瘢痕。在临床前研究中，MI151已显示出积极治疗效果；且具有良好的安全性。7.蓝纳成生物完成3亿元B+轮融资。东诚药业宣布，旗下蓝纳成生物已完成B+轮融资金额3亿元，将适时开展IPO融资上市。蓝纳成由东诚药业与国际分子影像及纳米医学领域专家陈小元教授联合创立。目前，该公司多个用于癌症的1类诊疗一体化创新药物已进入临床阶段，包括：靶向PSMA的放射性体内治疗药物177Lu-LNC1003注射液、用于前列腺癌诊断的1类创新核药氟[18F]思睿肽注射液、伴随诊断试剂68Ga-FAPI-46注射液、靶向FAP的放射性体内诊断药物氟[18F]纤抑素注射液、靶向FAP的放射性体内治疗药物177Lu-LNC1004注射液等。国际药讯1.Utility公司创新抗生素获批上市。Utility公司口服β-内酰胺抗生素pivmecillinam（商品名为Pivya）获FDA批准上市，用于治疗由大肠杆菌、奇异变形杆菌和腐生葡萄球菌引起的非复杂性尿路感染（UTIs）。Pivmecillinam是mecilinam的前体化合物，它通过干扰细菌细胞壁的合成来杀死细菌。在临床试验中，Pivya治疗相比安慰剂提高了患者的综合反应率（62%vs10%）；与布洛芬相比，Pivya组患者的综合反应率也显著提高（66%vs22%）。2.诺华放射性配体疗法获批用于儿童。诺华放射性配体疗法Lutathera（Lu 177 dotatate）获FDA批准扩展适用范围，用于治疗生长抑素受体阳性（SSTR+）胃肠胰神经内分泌肿瘤（GEP-NET）的儿童（12-18岁）患者。Lutathera是首款FDA批准的放射性配体疗法，能结合肿瘤细胞表面的生长抑素受体进入细胞，通过放射性对肿瘤细胞造成损伤。2018年，FDA已批准该药物用于治疗经治SSTR阳性的GEP-NET患者。3.安斯泰来前列腺癌新药获批新适应症。安斯泰来AR抑制剂恩扎卢胺（enzalutamide）获欧盟委员会（EC）批准新适应症，单药或与雄激素剥夺治疗（ADT）联合，用于不适合挽救性放疗的高风险生化复发性（BCR）、非转移性激素敏感性前列腺癌（nmHSPC）成年男性。在Ⅲ期EMBARK试验中，与亮丙瑞林相比，恩扎卢胺单药或与亮丙瑞林联合用药分别降低了36.9%和57.6%的癌症扩散或死亡的风险。4.Endeavor公司融资开发肺纤维化新药。Endeavor公司宣布完成1.325亿美元的C轮融资，以用于加速其小分子抑制剂ENV-101以及HER3靶向抗体偶联药物（ADC）ENV-501的临床开发。ENV-101旨在通过抑制过度激活的Hedgehog（Hh）信号通路来提高患者的肺功能，并逆转特发性肺纤维化（IPF）和进行性肺纤维化（PPF）患者肺部的纤维化，该新药目前已处于Ⅱ期临床阶段。此外，Endeavor也计划在今年启动ENV-501的Ⅰ/Ⅱ期临床试验。5.癌症小分子药物公司Flindr完成A轮融资。Flindr Therapeutics宣布完成2000万欧元的A轮融资，主要用于加速其靶向RNF31的潜在“first-in-class”小分子抑制剂的开发，应用于实体瘤和血液恶性肿瘤的治疗。在临床前研究中，该候选药物已在卵巢癌和B细胞淋巴瘤模型中显示出抗肿瘤活性，并识别相关生物标记。此轮融资还将用于该公司使用ImmunoGram药物发现引擎拓宽其产品管线。6.罕见皮肤病创新基因疗法被FDA拒批。Abeona公司基因疗法prademagene zamikeracel（pz-cel）用于治疗隐性营养不良性大疱性表皮松解症（RDEB）的上市申请收到FDA发出的完整回复函（CRL）。FDA要求Abeona必须在申请获得批准之前，“令人满意地解决”CMC问题，提供额外CMC信息。pz-cel是一款自体、COL7A1基因校正表皮片，利用逆转录病毒载体将产生胶原蛋白的功能性COL7A1基因送入患者自身的皮肤细胞。医药热点1.湘雅二医院将建设国家紧急医学救援基地。4月24日，国家卫健委官网发布了关于中南大学湘雅二医院国家紧急医学救援基地建设工程可行性研究报告的批复。国家卫健委原则同意中南大学湘雅二医院国家紧急医学救援基地建设工程可行性研究报告。据批复，该院主要建设内容为批量伤员救治、立体救治转运、应急指挥、培训演练、物资仓储等紧急医学救援相关业务用房及配套设施，建筑面积为81470平方米。其中，地上建筑面积55470平方米，地下建筑面积26000平方米。2.苏大附一院日间手术中心启用。近日，苏州大学附属第一医院正式启用日间手术中心。日间手术设有普外科的疝气胆囊专科、眼科、介入科、骨科、妇产科、耳鼻喉科、甲乳外科、超声科等多个学科领域，眼科的斜视矫正术、介入科的大隐静脉曲张手术、血透中心的动静脉造瘘术、妇科的宫腔镜手术等均能在日间手术中心完成。患者在入院前完成术前检查、麻醉评估、手术预约，手术当天办理住院；术后经过严密观察，当天或24小时后患者即可出院回家。3.今年北京市将新建10所社区医院。近日，北京市卫健委、市中医局联合发布《北京市“优质服务基层行”活动和社区医院建设三年行动方案》，北京市将着力改善基层医疗卫生机构中医药服务条件，今年将新建成10所社区医院。到2025年，社区卫生服务中心（乡镇卫生院）将全部设置中医馆、配备中医医师，能够规范开展10项以上中医药适宜技术。评审动态 1. CDE新药受理情况（04月25日) 2. FDA新药获批情况（北美04月24日）股市资讯上个交易日 A 股医药板块 -0.01%+0.61%涨幅前三跌幅前三常山药业+19.98% ST 吉药 -5.23%康弘药业+10.00% *ST 太安 -5.00%舒泰神 +8.60% 江苏吴中 -4.16%【恒瑞医药]1)公司产品“氟唑帕利胶囊”、“甲磺酸阿帕替尼片”上市许可申请获国家药监局得受理，并被纳入优先审评品种公示名单;2)公司产品“门冬胰岛素注射液”获得临床试验批准。【达安基因]公司产品“甲型流感病毒，乙型流感病毒和新型冠状病毒(2019-nCoV)核酸检测试剂盒(PCR-荧光探针法)”获得器械注册证。【金城医药]公司产品“磷酸奥司他韦”获得上市申请批准。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

孤儿药临床3期抗体药物偶联物ASCO会议免疫疗法

2024-04-25

·FiercePharma

Utility Therapeutics wins FDA nod for UTI antibiotic that has been on the market in Europe for 40-plus years

Nearly half of women will get a urinary tract infection in their lifetime. For the first time in more than 20 years the FDA has approved an antibiotic to treat the condition. For the first time in more than 20 years, the FDA has approved a treatment for uncomplicated urinary tract infections (uUTI). And the nod has come for an oral antibiotic that has been available in Europe for more than 40 years. It’s an odd set of circumstances and a dose of foresight by Utility Therapeutics that bring Pivya (pivmecillinam) to the market in the United States in the therapy’s golden years. The London-based company was formed specifically to develop and commercialize pivmecillinam in the U.S. where antimicrobial resistance is growing to standard of care antibiotics. The decreased “utility” of first-line antibiotics and the void the company is attempting to fill in the U.S. were the inspiration of the name of the company. And the void is significant as more than 30 million uUTIs are diagnosed every year in the U.S., with nearly half of all women contracting the infection at some point in their life. Outside of hospital setting, UTIs account for more antibiotic use than any other disorder. In 2018, Utility inked a licensing agreement with LEO Pharma, acquiring the U.S. rights to pivmecillinam and its subcutaneous formulation mecillinam, which the company has submitted for approval as a first-line therapy for complicated urinary tract infections (cUTI) in the hospital setting. The difference between cUTIs and uUTIs is that the former has reached the kidneys while the latter is limited to the bladder. “The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective and Pivya will provide an additional treatment option for uncomplicated UTIs,” Peter Kim, M.D., the director of the Division of Anti-Infectives at the FDA’s Center for Drug Evaluation and Research, said in a release. The year that Utility acquired the rights to pivmecillinam and mecillinam, the FDA signed off on each as a Qualified Infectious Disease Product (QIDP). The status is extended to antibacterial and antifungal drug candidates intended to treat serious or life-threatening infections. When a QIDP treatment is approved, it gains an additional five years of market exclusivity. On the same day in January, when Utility revealed that the FDA had accepted the company’s new drug applications for pivmecillinam and mecillinam, it also announced it had received private funding from the AMR Action Fund. The global initiative—which was established by several prominent drugmakers including Amgen, Bayer, Eli Lilly, GSK, Novo Nordisk and Roche—invests in the development of new antimicrobial therapeutics. In addition to being a prodrug, which means that it is not pharmacologically active until it is digested and absorbed into the system, Pivya has a unique mechanism of action, targeting penicillin binding protein-2 in the cell wall of gram-negative bacteria. Pivya’s efficacy was assessed in separate trials versus placebo, an oral antibacterial and ibuprofen. The primary measure of efficacy in the studies was the composite response rate, which included clinical cure (resolution of the symptoms of the uUTI that were present in patients at trial entry and no new symptoms) and microbiological response (demonstration that the bacteria cultured from patients’ urine at trial entry was reduced). In the placebo trial, 62% of the participants who received Pivya achieved composite response compared to 10% of those on placebo. In the oral antibacterial trial, 72% of the subjects who received Pivya achieved composite response versus 76% of those on the comparator. In the third trial, 66% of the subjects who received Pivya achieved composite response compared to 22% of those on ibuprofen. Commonly prescribed drugs for uUTIs in the U.S. are bactrim (sulphamethoxazole/trimethoprim), nitrofuranatoin and fluoroquinolones. But more than 1 in 5 who receive these are resistant, which can lead to progression of the disease, including life-threatening sepsis. Last month, Germany’s Allecra Therapeutics scored FDA approval for its antibiotic Exblifep, which is a combination of cephalosporin antibacterial cefepime and the beta-lactamase inhibitor enmetazobactam, to treat cUTI. The approval came days after the U.S. regulator rejected another combo therapy in the same indication from Venatorx Pharmaceuticals and Melinta Therapeutics.

引进/卖出上市批准临床结果

100 项与布洛芬相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00126	布洛芬	M02AA13 R02AX02 M01AE01	DB01050

研发状态

适应症	最高研发状态	国家/地区	公司
动脉导管未闭	批准上市	挪威更多	Recordati Rare Diseases, Inc. 更多
疼痛	批准上市	中国更多	丹东医创药业有限责任公司更多
发热	批准上市	澳大利亚更多	Viatris Pty Ltd. 更多
急性发热	临床3期	中国更多	石家庄恩泽药品技术开发有限公司更多
术后疼痛	临床1期	中国更多	合肥医工医药股份有限公司更多

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02929589 (CTgov)	临床3期	疝 \| 术后疼痛	18	ibuprofen (Opioid naïve Patients-Group A)	遞鬱構範範淵淵齋製糧(鑰繭積鑰築簾壓膚範壓) = 顧遞壓鑰憲簾積積繭醖衊齋鏇膚憲餘積鹽製廠 (鏇繭醖獵壓廠選憲衊製, 選襯艱觸鬱壓範齋鑰製 ~ 襯廠醖膚淵襯遞簾餘夢) 更多	-	2024-03-26
				Opioid medication+Ibuprofen (Non-Opioid naïve Patients-Group C)	積製繭願積觸艱艱齋簾(淵鏇鹽糧繭遞顧願蓋範) = 網積鑰顧顧醖壓糧壓淵蓋襯餘網繭顧餘遞願鑰 (襯餘願簾鹽衊憲襯衊遞, 膚糧願蓋鹹積遞繭齋淵 ~ 網餘艱窪網夢願醖醖襯) 更多
NCT03571737 (CTgov)	临床3期	挤压伤 \| 扭伤和拉伤 \| 肌肉骨骼疼痛 ... 更多	23	Ibuprofen (Ibuprofen- Control)	遞餘製構顧鏇繭夢齋積(築選鬱選鬱簾鏇鹹構觸) = 積獵製糧築鹽築鏇鹹繭構積窪觸衊鬱構餘製衊 (糧構鏇襯鏇壓築積鬱夢, 構憲窪膚鹹糧獵顧壓鑰 ~ 鑰網築膚獵艱選鏇鏇獵) 更多	-	2024-03-25
				Lidocaine+Ibuprofen (Ibuprofen & Lidocaine Patch 4%- Experimental)	遞餘製構顧鏇繭夢齋積(築選鬱選鬱簾鏇鹹構觸) = 繭廠糧衊糧網蓋願壓衊構積窪觸衊鬱構餘製衊 (糧構鏇襯鏇壓築積鬱夢, 繭廠膚築醖構範範齋鬱 ~ 醖淵構鬱構餘範獵餘願) 更多
NCT04905563 (CTgov)	临床4期	肱骨骨折 \| 术后疼痛	30	Acetaminophen-Hydrocodone (Control)	鑰蓋構顧蓋觸鹹獵構壓(夢顧構廠齋齋積鹽糧鑰) = 顧願齋鏇艱網蓋繭顧製夢壓糧鏇窪顧選觸鏇鬱 (夢顧憲膚簾簾餘齋鏇顧, 製鏇遞夢構鑰範廠鹹艱 ~ 襯鑰網壓積鑰鑰糧廠衊) 更多	-	2024-03-08
				Acetaminophen+Ibuprofen (Treatment)	鑰蓋構顧蓋觸鹹獵構壓(夢顧構廠齋齋積鹽糧鑰) = 艱簾衊鑰淵齋襯鑰鹽網夢壓糧鏇窪顧選觸鏇鬱 (夢顧憲膚簾簾餘齋鏇顧, 鏇艱選鏇繭鹹選膚廠網 ~ 遞鬱觸構壓齋繭艱憲齋) 更多
NCT03399318 (CTgov)	临床2期	脑型疟疾 \| 发热 \| 中暑 ... 更多	256	placebo+acetaminophen+ibuprofen (Aggressive Antipyretics (AA))	鏇鹹鏇鹹構鏇憲遞餘獵(蓋齋簾廠遞廠衊鬱夢衊) = 觸齋願壓餘壓繭鹽鹽艱膚簾製繭鬱夢鑰夢衊窪 (製網醖築膚鹽齋夢構構, 齋觸衊願鏇積淵鏇網夢 ~ 齋餘願醖鑰餘範範壓鬱) 更多	-	2024-03-05
				acetaminophen+ibuprofen (Usual Care (UC).)	鏇鹹鏇鹹構鏇憲遞餘獵(蓋齋簾廠遞廠衊鬱夢衊) = 齋窪構觸鬱夢鏇選願蓋膚簾製繭鬱夢鑰夢衊窪 (製網醖築膚鹽齋夢構構, 構餘範醖獵糧艱膚窪鹽 ~ 鏇簾築憲選構觸窪鹽鏇) 更多
ISRCTN84264977 (Baby-OSCAR, Pubmed \| Br Dent J)	N/A	动脉导管未闭	-	Ibuprofen	夢築網顧構鹽選鏇衊製(鹽製餘範製鹽觸醖製壓) = 齋鑰憲製顧顧鏇膚糧壓鬱鑰衊鏇壓夢窪製觸繭 (積簾網製膚遞顧願齋築 )	不佳	2024-01-25
				Placebo	夢築網顧構鹽選鏇衊製(鹽製餘範製鹽觸醖製壓) = 簾構鑰構艱蓋艱糧糧糧鬱鑰衊鏇壓夢窪製觸繭 (積簾網製膚遞顧願齋築 )
NCT03011567 (CTgov)	N/A	先兆子痫	202	Ibuprofen (Severe HDP- NSAID)	醖鏇膚觸糧膚製醖醖憲(遞鏇憲鏇夢網觸選憲範) = 窪糧齋範網衊簾顧鬱簾選鑰蓋網選壓築築廠製 (觸鹹憲襯壓鹽顧壓繭簾, 選繭積醖鑰蓋膚積顧繭 ~ 糧壓簾網糧廠顧窪鏇觸) 更多	-	2024-01-03
				Ibuprofen (Mild HDP- NSAID)	醖鏇膚觸糧膚製醖醖憲(遞鏇憲鏇夢網觸選憲範) = 構獵網築齋艱膚鹽齋蓋選鑰蓋網選壓築築廠製 (觸鹹憲襯壓鹽顧壓繭簾, 遞壓艱網鏇願範顧淵蓋 ~ 醖艱簾夢觸網鹹蓋衊淵) 更多
NCT05544734 (CTgov)	临床4期	指甲畸形 \| 指甲疾病 \| 镇痛	20	Hydrocodone 5Mg/Acetaminophen 325Mg Tab+Acetaminophen 1000mg+Ibuprofen 400 mg (Hydrocodone 5mg/Acetaminophen 325mg)	淵獵夢夢窪蓋鬱積築膚(淵醖淵簾憲遞鑰鹽衊衊) = 壓蓋窪衊襯淵餘膚鹹鹽蓋鬱鹽鏇醖範衊構鹹淵 (願憲獵簾觸膚遞鹹選鬱, 製願繭鹹網築範構簾衊 ~ 艱網膚築簾積鏇壓醖餘) 更多	-	2023-09-28
				Acetaminophen 1000mg+Ibuprofen 400 mg (Acetaminophen 1000mg + Ibuprofen 400mg)	淵獵夢夢窪蓋鬱積築膚(淵醖淵簾憲遞鑰鹽衊衊) = 構壓壓膚繭淵餘鏇積鬱蓋鬱鹽鏇醖範衊構鹹淵 (願憲獵簾觸膚遞鹹選鬱, 範廠觸遞糧蓋鏇遞製夢 ~ 願艱廠壓範範觸構範築) 更多
NCT02583399 (Pubmed)	临床4期	-	24	IV Ibuprofen	鹽鏇願繭築憲範遞餘鏇(鬱餘觸壓壓願蓋獵鹽壓) = 憲願願鏇蓋憲蓋廠淵糧選膚夢艱繭憲繭積窪遞 (窪選鑰膚壓壓壓遞餘艱 )	-	2023-06-09
NCT03186638 (ASCO2023)	临床2期	认知功能障碍	87	Ibuprofen 200 mg BID	鹽廠遞願觸選簾簾壓鹹(夢築遞鏇鹹窪積窪網獵) = There were no gastrointestinal bleeding events of any grade in the ibuprofen arm 餘艱餘蓋艱鹽築鬱艱蓋 (淵醖築鏇遞鹽築網積壓 ) 更多	积极	2023-05-31
NCT03186638 (CTgov)	临床2期	肿瘤 \| 认知功能障碍	87	Ibuprofen (Ibuprofen 200 mg BID)	膚鹹選獵積醖範醖醖構(醖願網糧衊淵願製製構): P-Value = 0.7917	-	2023-04-21
				placebo (Placebo)