Comparative Study Between Use of Alpha Blocker Versus Alpha Blocker and Antihistaminic in Management of Acute Renal Colic Prevent Pain Recurrence and Increase Expulsion Rate of Ureteric Stone ≤ 1cm

Urolithiasis is one of the most common urological diseases. The risk of stone disease ranges between 5% and 12% worldwide. Ureteric stones account for ≈20% of all urinary tract stones and >70% of the ureteric stones are located in the lower third of the ureter, i.e., distal ureteric stones (DUS). The colicky-type pain in the ureter, an increase in proximal peristalsis through activation of intrinsic ureteral pacemakers may contribute to the perception of pain. Muscle spasm increased proximal peristalsis, local inflammation, irritation, and oedema at the site of obstruction may contribute to the development of pain through chemoreceptor activation and stretching of submucosal free nerve endings. α-adrenergic blockers, anti-inflammatory drugs, antihistaminic and calcium channel blockers, which have a relaxant effect on the ureteric smooth musculature. The presence of histamine receptors in the ureter have been presented in various studies. The histamine-1 (H1) receptors have been shown to have a wide distribution Histamine, which is secreted from the mast cells, causes strong peristaltic contractions in the ureter. alpha adrenoreceptor antagonists (i.e., tamsulosin) have been employed in the treatment of ureteric colic due to smooth muscle relaxation so their potential ability to increase stone passage, reduce pain medication use and reduce urologic interventions. According to the currently accepted view, renal colic management starts with NSAI drugs also NSAI has role in decrease inflammation and oedema and increase expulsion rate . in this study we will compare the use of alpha blocker versus alpha blocker and antihistaminic in management of acute renal colic prevent pain recurrence and increase expulsion rate of ureteric stone ≤ 1cm, with analgesic use in case of acute stage.

开始日期2021-11-30

申办/合作机构

Assiut University

NCT05131555 / CompletedN/AIIT

Influence of Endurance Training and Histamine Receptor Antagonists on the Transcriptome Response in Human Muscle

Blocking histamine H1/H2 receptors blunts chronic endurance training adaptations. The current study addresses a twofold research question: "What is the influence of endurance training (1) and histamine H1 and H2 signaling (2) on the gene expression in human skeletal muscle." Results from this study will yield more insights into the molecular mechanisms of adaptations to exercise training.

开始日期2021-08-16

申办/合作机构

Ghent University

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100 项与伪麻非索相关的临床结果

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100 项与伪麻非索相关的转化医学

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100 项与伪麻非索相关的专利（医药）

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项与伪麻非索相关的文献（医药）

2024-02-21·Pharmaceutical research

An Evaluation of Wet Granulation Process Selection for API Prone to Polymorphic Form Conversion in the Presence of Moisture and Heat.

Article

作者: Freddy Arce ; Yue Schuman ; John Gawel ; Robert Garmise ; Admassu Abebe ; Divyakant Desai

PURPOSE:

Wet granulation (WG) is one of the most versatile processes to improve blend properties for processing. However, due to its need for moisture and heat, it is often considered not amenable to active pharmaceutical ingredients (APIs) prone to forming hydrates. Despite this claim, little literature exists evaluating the extent to which polymorphic form conversions occur for such API when processed with WG. This work sets out to explore two common WG methods, high-shear (HSG) and fluid-bed (FBG), and two drying processes, tray-drying (TD) and fluid-bed drying (FBD), and evaluate the risk they pose to hydrate form conversion.

METHODS:

The progression of anhydrous to hydrate form conversion of two model compounds with vastly different solubilities, fexofenadine hydrochloride and carbamazepine, was monitored throughout the various processes using powder X-ray diffraction. The resultant granules were characterized using thermogravimetric analysis, differential scanning calorimetry, BET adsorption, and sieve analysis.

RESULTS:

FBG and FBD processing resulted in the preservation of the original form of both APIs, while HSG+TD resulted in the complete conversion of the API. The FBD of fexofenadine and carbamazepine granules prepared with HSG resulted in partial and complete re-conversion back to the original anhydrous forms, respectively.

CONCLUSION:

The drying process is a critical factor in anhydrous form conservation. FBG and FBD yielded better preservation of the initial anhydrous forms. HSG could be an acceptable granulation method for API susceptible to hydrate formation if the API solubility is low. Selecting an FBG+FBD process minimizes API hydrate formation and preserves the original anhydrous form.

2024-02-21·Journal of neuroinflammation

Integration of National Health Insurance claims data and animal models reveals fexofenadine as a promising repurposed drug for Parkinson's disease.

Article

作者: Jae-Bong Kim ; Yujeong Kim ; Soo-Jeong Kim ; Tae-Young Ha ; Dong-Kyu Kim ; Dong Won Kim ; Minyoung So ; Seung Ho Kim ; Hyun Goo Woo ; Dukyong Yoon ; Sang Myun Park

BACKGROUND:

Parkinson's disease (PD) is a common and costly progressive neurodegenerative disease of unclear etiology. A disease-modifying approach that can directly stop or slow its progression remains a major unmet need in the treatment of PD. A clinical pharmacology-based drug repositioning strategy is a useful approach for identifying new drugs for PD.

METHODS:

We analyzed claims data obtained from the National Health Insurance Service (NHIS), which covers a significant portion of the South Korean population, to investigate the association between antihistamines, a class of drugs commonly used to treat allergic symptoms by blocking H1 receptor, and PD in a real-world setting. Additionally, we validated this model using various animal models of PD such as the 6-hydroxydopmaine (6-OHDA), α-synuclein preformed fibrils (PFF) injection, and Caenorhabditis elegans (C. elegans) models. Finally, whole transcriptome data and Ingenuity Pathway Analysis (IPA) were used to elucidate drug mechanism pathways.

RESULTS:

We identified fexofenadine as the most promising candidate using National Health Insurance claims data in the real world. In several animal models, including the 6-OHDA, PFF injection, and C. elegans models, fexofenadine ameliorated PD-related pathologies. RNA-seq analysis and the subsequent experiments suggested that fexofenadine is effective in PD via inhibition of peripheral immune cell infiltration into the brain.

CONCLUSION:

Fexofenadine shows promise for the treatment of PD, identified through clinical data and validated in diverse animal models. This combined clinical and preclinical approach offers valuable insights for developing novel PD therapeutics.

2024-02-02·European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V

Fexofenadine-loaded chitosan coated solid lipid nanoparticles (SLNs): A potential oral therapy for ulcerative colitis.

Article

作者: Walaa A El-Dakroury ; Moataz B Zewail ; Gihan F Asaad ; Heba M I Abdallah ; Marwa E Shabana ; Abdelrahman R Said ; Ahmed S Doghish ; Hadeer A Azab ; Dalia H Amer ; Ahmed E Hassan ; Alaa S Sayed ; Ghada M Samra ; Al-Aliaa M Sallam

The targeting and mucoadhesive features of chitosan (CS)-linked solid lipid nanoparticles (SLNs) were exploited to efficiently deliver fexofenadine (FEX) into the colon, forming a novel and potential oral therapeutic option for ulcerative colitis (UC) treatment. Different FEX-CS-SLNs with varied molecular weights of CS were prepared and optimized. Optimized FEX-CS-SLNs exhibited 229 ± 6.08 nm nanometric size, 36.3 ± 3.18 mV zeta potential, 64.9 % EE, and a controlled release profile. FTIR, DSC, and TEM confirmed good drug entrapment and spherical particles. Mucoadhesive properties of FEX-CS-SLNs were investigated through mucin incubation and exhibited considerable mucoadhesion. The protective effect of FEX-pure, FEX-market, and FEX-CS-SLNs against acetic acid-induced ulcerative colitis in rats was examined. Oral administration of FEX-CS-SLNs for 14 days before ulcerative colitis induction reversed UC symptoms and almost restored the intestinal mucosa to normal integrity and inhibited Phosphatidylinositol-3 kinase (73.6 %), protein kinase B (73.28 %), and elevated nuclear factor erythroid 2-related factor 2 (185.9 %) in colonic tissue. Additionally, FEX-CS-SLNs inhibited tumor necrosis factor α (TNF-α) and interleukin 6 (IL-6) to (70.79 % & 72.99 %) in colonic tissue. The ameliorative potential of FEX-CS-SLNs outperformed that of FEX-pure and FEX-market. The exceptional protective effect of FEX-CS-SLNs makes it a potentially effective oral system for managing ulcerative colitis.

项与伪麻非索相关的新闻（医药）

2023-05-11

·drugs

The Most Common Allergy Medicines

THURSDAY, May 11, 2023 -- If you suffer from allergies, you know how bothersome and uncomfortable the sneezing and itchy eyes can be. These symptoms are more than irritating — they impact day-to-day activities like work, school, sports, sleeping and even eating. Not only that, but allergies can also cause more serious health problems such as asthma and even anaphylaxis, a life-threatening allergic reaction. Allergies are a common health condition affecting almost one-third of adults in the United States and just over one-quarter of children under 17, according to the U.S. Centers for Disease Control and Prevention . But there is relief at hand: Here’s what you need to know about the most common allergy medicines, the type of allergies they treat, how they work and common side effects. Antihistamines This type of allergy medicine is very effective in relieving allergy symptoms. Mayo Clinic explains this drug type works by blocking histamine, “a symptom-causing chemical released by your immune system during an allergic reaction.” Antihistamines are available as an over-the-counter medication or as a prescription allergy medicine, and they are sold in oral form, as a nasal spray or as eyedrops. This allergy medicine treats symptoms of indoor and seasonal allergies. Common side effects of antihistamines include drowsiness, dry mouth, dizziness, blurred or double vision, mucous thickening and low blood pressure. Common antihistamines include: Oral Loratadine (Alavert, Claritin) Cetirizine (Zyrtec) Diphenhydramine (Benadryl) Doxylamine (Vicks NyQuil, Tylenol Cold and Cough Nighttime) Fexofenadine (Allegra) Nasal spray Olopatadine (Patanase) Eyedrops Ketotifen (Zaditor) Leukotriene modifiers Leukotriene modifiers prevent or lessen the symptoms of allergic rhinitis (hay fever) and allergic asthma. The Cleveland Clinic explains that leukotrienes are chemicals released in the body when you come in contact with an allergen. This causes symptoms like a runny nose and coughing. Leukotriene inhibitors block the effects leukotrienes have on the body or “stop your body from producing them.” This allergy medicine treats symptoms of indoor and seasonal allergies. Leukotriene inhibitors can cause side effects such as cold or flu symptoms, headache, diarrhea, fatigue and itchy skin or rash. More serious side effects like depression, thoughts of suicide, hives, trouble breathing, vomiting and yellowing of the skin or eyes can occur. You should seek medical treatment in these cases. Common leukotriene inhibitors include: Montelukast (Singulair) Zafirlukast (Accolate) Zileuton (Zyflo) Corticosteroids Corticosteroids treat mild to severe allergy symptoms by reducing inflammation caused by your body’s reaction to an allergen. Corticosteroids are available in several forms including pills and liquids, nasal sprays, inhalers, creams and eyedrops. They treat allergic inflammation caused by indoor and seasonal allergens as well as insect stings. Severe allergic reactions are treated with oral corticosteroids, according to the Mayo Clinic. Side effects vary depending on the medication form, but can include increased blood glucose levels, high blood pressure, nosebleeds, mouth and throat irritation, and skin irritation. Common corticosteroids by form include: Pills and liquids Prednisolone (Prelone) Methylprednisolone (Medrol) Nasal sprays Budesonide (Rhinocort) Mometasone (Nasonex) Inhalers Fluticasone (Flovent) Mometasone (Asmanex Twisthaler) Creams Betamethasone (Dermabet, Diprolene) Desonide (Desonate, DesOwen) Eyedrops Fluorometholone (Flarex, FML) Loteprednol (Alrex, Lotemax) Immunotherapy Immunotherapy works by modifying the immune system and its reaction to allergens. It’s not used for immediate allergy symptom relief but is a long-term allergy treatment. Immunotherapy treatments (or allergy shots) are prescription medicines. "Allergy shots can be helpful for patients with seasonal and year-round allergies," Miranda Curtiss , an assistant professor at the University of Alabama at Birmingham School of Medicine, said in a recent article . "However, these are a long-term investment that require planning to continue therapy for three to five years for maximal benefit. Asthmatics who want to start allergy shots need to have their asthma under good control first before starting shots." With allergy shots, you are exposed to an allergen over and over until your immune system becomes desensitized and no longer reacts to the allergen, the Mayo Clinic says. This type of treatment is commonly given as allergy shots (subcutaneous immunotherapy, or SCIT), but is also available in a form given under the tongue (sublingual immunotherapy, or SLIT). With SCIT, injections are given in your doctor’s office where they can monitor for adverse reactions. Treatment starts with the “build-up phase,” which is once or twice a week, and decreases to a maintenance dose which is once every two to four weeks. Sublingual immunotherapy treatment, like subcutaneous immunotherapy, also exposes you to allergens over a period of time, with the goal of building immunity to the allergen. SLIT tablets are available by prescription and taken daily. Immunotherapy is used to treat seasonal and indoor allergies, as well as insect stings. Side effects include watery eyes, sneezing, mild asthma symptoms, a rash at the injection site, tiredness and headaches. In rare cases, life-threatening reactions such as throat swelling and difficulty breathing can occur. Regardless of the type of allergy or your symptoms, there are options for relief. Reach out to your health care provider to learn more about which remedies are best for you. Posted May 2023

免疫疗法

2022-08-27

·药时代

药品召回面面观：你遭遇过问题药物吗？

1前言2022年8月，三批Clingen公司生产的盐酸美西律硬胶囊因可能存在剂量不足或过量，已发出 I类药品召回通知。召回的原因在于胶囊的载药量发生偏差，存在过载或者计量不足的潜在风险，有可能给患者造成安全隐患。药品安全性永远被视为药品研发、申报、生产、销售与售后监察领域内重要的因素。药品在提供给消费者之前经过严格的安全性和有效性测试。一旦投放市场，包括FDA在内的药监机构会与药品制造商一起继续监测药品是否存在任何不可预见的问题。如果出现问题或药品的安全性受到质疑，则可能会发起召回。药品召回是保护公众免受缺陷或潜在有害产品影响的最有效手段。根据 FDA 的定义，药品召回的概念为：当发现药品违反 FDA 管理的法律和法规时，制造商所执行的从市场中移除缺陷或有害药品的行动。药品可能因各种原因被召回，包括安全性、错误标签、污染以及强度或效力偏差。召回可作为制造商或供应商的自愿行动，或应 FDA 的要求，或者通过 FDA的法定命令。2药物召回的原因药品召回的原因，大体上可以划分为以下几个方面：1对健康构成危害尽管通过了临床试验，但某些药品对于患者的健康威胁却在它们被广泛使用后才浮出水面。例如召回含有PPA（phenylpropanolamine, 苯丙醇胺）的药品。在发现PPA与出血性中风或脑出血的风险相关联后, FDA要求制造商将含有PPA的药品从美国市场全部召回。而此前很多治疗感冒与咳嗽的非处方药中都含有PPA成分。另一个例子是减肥药西布曲明（Sibutramine）。因为它会增加患心脏病和中风的风险, Sibutramine 于 2010 年8月被其制造商雅培（在FDA的压力下）从美国市场召回。值得注意的是，目前很多市售减肥药中仍然含有Sibutramine可疑成分。2011 年 10 月，FDA 警告说 20 个品牌的膳食补充剂被Sibutramine污染。在 2018 年的一项研究中，FDA 在 700 多种冠以“天然”、“传统”或“草药”头衔的膳食补充剂中发现了包括Sibutramine在内的合成添加剂。 2污染在生产或分销过程中，药品可能会被有害或无害物质污染，被污染的药品原则上也应该被召回。2022年6月，Vi-Jon自愿将所有口味的柠檬酸镁盐水泻药口服溶液召回。召回是在 Vi-Jon的第三方微生物测试确定问题批次的产品被葡糖酸醋酸杆菌污染，这可能导致危及生命的不良健康后果。3贴错标签或包装不当由于不当的给药指导，亦或随药品提供的给药工具出现问题，某种药品也会被召回。2022年6月，Bryant Ranch Prepack 公司自愿召回一个批次的30毫克硫酸吗啡缓释片剂和一个批次的60毫克缓释片剂硫酸吗啡。召回的理由是这些问题批次的产品标签不正确，其中标有60 毫克硫酸吗啡缓释片剂的瓶子含有30 毫克硫酸吗啡缓释片剂，而标有30 毫克硫酸吗啡缓释片剂的瓶子可能含有60 毫克硫酸吗啡缓释片剂。服用 30 mg 剂量的患者接受 60 mg 剂量可能有过量和死亡的风险。如果给予的剂量太低，服用 60 mg 剂量的患者接受 30 mg 剂量可能会出现戒断和未经治疗的疼痛。 4毒性杂质2019年，由于检测到致癌物杂质 N-Nitroso-N-methyl-4-aminobutyric acid （NMBA, N-亚硝基-N-甲基-4-氨基丁酸），FDA 要求 Teva Pharmaceuticals召回 44 批生产并标记为 Golden State Medical Supply 的氯沙坦钾片。FDA与EMA以此为契机，要求制造商，包括原料药与成品药的制造商，彻底检查其工艺中产生亚硝胺杂质的风险。2022年，Sandoz Inc.主动召回 13 批口服奥芬那君 100 mg 缓释 (ER) 片剂。原因又是亚硝胺（N-甲基-N-亚硝基-2-[(2-甲基苯基)苯基甲氧基]乙胺（NMOA 或 Nitroso-Orphenadrine））杂质的存在，该杂质有可能超过FDA规定的每日可接受摄入量 (ADI) 上限（ 26.5 ng/天）。 5不过关的生产工艺与产品质量、纯度和效力相关的制造缺陷可能是药品召回的罪魁祸首。2022年5月， Teva Pharmaceuticals USA 在全国范围内主动召回一批阿那格雷胶囊。此次自愿召回是由于在常规稳定性测试期间检测到溶出度测试失败而发起的。不符合质量标准的溶出度，可以导致药品摄入后需要较长时间溶解，引发药品降低血小板作用有效性的降低或无效。对于血小板计数升高的重症患者，体内较低浓度的阿那格雷可能会增加凝血（血液凝固）和凝血或出血事件（如心脏病发作或中风）的风险，这可能会危及生命。3FDA在药品召回事件中扮演的角色大多数药品召回是自愿的：制造商发现问题并召回受影响的药品。然而，制造商有时是在 FDA 提出问题后召回药品。不管召回的原因是什么，FDA 的作用是监督制造商的策略，评估和确保其处理召回的适当性。依其严重程度，药品召回被划分为三个档次：I 类：可能导致严重健康问题或死亡的危险或有缺陷的产品。II 类召回适用于可能导致暂时性健康问题，或者仅仅性质严重但威胁轻微的产品。比如一种药力不足但不用于治疗致命疾病的药物。III 类召回适用于不太可能引起任何不良健康反应但违反 FDA 标签或制造法规的产品。例如容器缺陷（塑料材料分层或盖子未密封）。1提醒公众要知道并非所有召回都会在 FDA的网站或新闻媒体上公布。当被召回的问题药品已经广泛销售或对健康构成严重危害时，通常会发布公告。但是，如果涉事公司不发布召回的公开通知，FDA 出于保护患者健康不受威胁的考虑，可能会选择向大众公布药品召回的消息。患者还可以通过制造商、医疗保健专业人员或药剂师的得知他们的药品已被召回的信息。如果患者正在使用被召回批次的药品，应与医疗保健专业人员讨论最好的方案。通常，最严重的I 类召回通知会为患者提供操作说明。FDA 会建议患者遵循召回公司提供的说明。2每周执行报告所有召回每周发布在 FDA 执法报告中。分类的召回将根据危险程度分为 I 类、II 类或 III 类。尚未分类的正在进行的召回则会被冠以 “尚未分类”的头衔。在确定召回分类后，召回在执法报告中更新为适当的分类。3确认药品召回的效应FDA 通过分析制药公司在药品召回过程中是否有效地通知消费者，移除市场上的问题批次的药品，以此作为标准评估药品召回的有效性。如果召回被确定为无效，FDA 将要求公司采取额外行动。4史上影响较大的药物召回案例1. 己烯雌酚 (Diethylstilbestrol, DES) 己烯雌酚为非甾体雌激素类药物，于1938年首次合成。DES 的处方已超过 30 年，针对怀孕期间的流产和其他并发症。直到 1971 年，DES才被发现与一种罕见的肿瘤有关，这种肿瘤不断出现在服用它的女性患者的女儿身上。FDA 只禁止女性使用DES 处方，因为在男性中没有发现此类问题。事实上，仍然可以给男性开处方来治疗雌激素缺乏症。关于 DES 的诉讼导致了具有里程碑意义的产品责任裁决，这深远地影响了法院和 FDA 如何对多家制造商进行药物监督。最后一个生产己烯雌酚的美国制药企业礼来公司在1997年停止生产销售己烯雌酚。2.芬-芬（原料药：芬氟拉明Fenfluramine/芬特明Phentermine）‍•制造商：惠氏•召回时间：1997年（上市24年后）•经济损失：约210亿美元制药公司 Wyeth-Ayerst Laboratories 生产的芬-芬（Fen-Phen）减肥药于1970年上市，上市后24 年的1997年才被召回。原因是FDA 发芬芬的服用导致数千人罹患危险甚至致死的心肺机能障碍（心脏病、高血压和其他肺部问题）。据估计大约有 650 万人服用了这种药物来对抗肥胖。芬芬上市后的几十年间，经历了超过 50000 起诉讼和史上最大之一的产品责任赔偿，致使惠氏损失了近 210亿美元。3.特非那定（商标名Seldane®, 原料药：特非那定Terfenadine）•制造商：Hoechst Marion Roussel（现为赛诺菲）•召回时间：1997 年（上市 13 年后）•经济损失：1996年市场销售额 4.4 亿美元。 Seldane 是一种流行的抗组胺药，于 1985 年上市，用于治疗过敏而不引起嗜睡。在服用 Seldane 和其他药物的患者出现心律失常（心脏电活动异常）病例后，FDA 要求制造商召回。此次召回主要因其规模而引人注目。截至 1990 年，全球有超过1亿患者使用Seldane。在被召回后，Hoechst通过引入 Allegra（原料药：Fexofenadine，一种与 Seldane 非常相似但副作用低的药物）在一定程度上减轻了其损失。 4.米贝地尔(商标名：Posicor®，原料药：米贝地尔Mibefradil)•制造商：罗氏•召回：1998年（上市一年后）•经济损失：4年内销售额预计29亿美元。在市场上仅一年，Posicor 便与 123 名患者死亡扯上了关系。Posicor 在单独服用时被认为是相对安全的，当与 25 种不同药物中的任何一种结合使用时可能会致命。考虑到这种药物在一年内被开给全球不超过 20 万人的相对较小的数字，大量死亡是很惊人的。Posicor例子给了FDA一个沉重的教训，在对药物授予加速审批通道时应该做何深入准备？否则，药物匆忙上市有可能造成无法挽回的后果。5.曲格列酮（商标名：Rezulin®等，原料药：曲格列酮Troglitazone）•制造商：华纳-兰伯特•召回：2000 年（上市一年后）•经济损失：召回前的总销售额为 21 亿美元曲格列酮为噻唑烷二酮类口服降血糖药物，可改善胰岛素抵抗，增加人体组织对胰岛素的敏感性，增强胰岛素的作用。由于其不良反应（被发现与肝炎有因果关系），2000年3月美国FDA通知撤销该品种。但FDA本应更早召回曲格列酮，但由于制造商的投诉而推迟了召回。一名FDA的“吹哨医生”后来在制造商华纳-兰伯特的压力下被调离职位，并导致了召回过程的延迟。 6.苯丙醇胺 (PPA，phenylpropanolaminde)•制造商：没有主要制造商，在整个行业中广泛制造•2000 年（市场上至少 60 年）•经济损失：数以百万计，甚至数十亿美元（仅一家制造商就高达1500 万美元）。苯丙醇胺（Phenylpropanolamine，PPA），又称去甲基麻黄素或去甲麻黄碱，是一种精神活性药物。苯丙醇胺的独特性在于FDA从未正式批准过它。几十年来，它被用于从节食到感冒药再到治疗心理障碍的广泛领域，它存在于一种既不被禁止也不被完全认可的边缘。直到 2000 年耶鲁大学的一项分析认识到它与心脏事件和中风有关，尤其是在女性中危害更高。该研究估计，在 3 天内服用含有改成分药物作为食欲抑制剂的女性，每 107,000 至 3,268,000 人中，就有 1人可能因苯丙醇胺而中风。FDA 估计，如果 PPA 被更为安全的药物取代，美国全年可以预防 200 到 500 次中风。多家制药公司已经遭受到超过 25,000 起诉讼，整个制药行业的损害赔偿金额达到数亿甚至数十亿美元。7.西立伐他汀（商标：Baycol®,原料药：Cerivastatin 西立伐他汀）•制造商：拜耳•召回：2001 年（上市四年后）•经济损失：诉讼相关损失总计 12 亿美元据报道，作为治疗高胆固醇的药物的 Baycol ，至2001年在美国导致400多例横纹肌溶解症，其中31例患者不治身亡。其他国家共有21例西立伐他汀引起致死性横纹肌溶解症的报告。2001年8月8日，拜耳制药公司宣布从国际药品市场撤出西立伐他汀，FDA表示支持此决定。8月9日，中国国家食品药品监督管理局随即发出紧急通知，禁止使用西立伐他汀。8.罗非考昔（商标名：万络Vioxx®，原料药：Rofecoxib罗非考昔或罗非昔布）•制造商：默克•召回：2004 年（上市五年后）•经济损失：仅诉讼相关费用就接近 60 亿美元。 Vioxx 被认为是历史上最大的药品召回事件，也是引起公众最强烈抗议的事件之一。Vioxx 被作为关节炎止痛的处方药开给过超过2000万患者，但被发现会增加心脏病发作和中风的风险。默克和 FDA 都因在最终召回之前忽视了 Vioxx 危险的证据而受到严厉批评。据《柳叶刀》报道，仅在美国就有多达 14 万人因服用该药而患上严重的冠心病。默克以 48 亿美元和解了万络在美国的诉讼，法律费用接近 10 亿美元。9.伐地昔布（商标名：Bextra®，原料药名：伐地昔布或伐地考昔Valdecoxib）•制造商：辉瑞•召回：2005 年（上市仅一年后）•经济损失：超过 20 亿美元的法律裁决和费用。 Bextra 和 Vioxx 一样，是一种非甾体抗炎药，用于治疗关节炎和其他炎症性疾病引起的疼痛。拔出萝卜带出泥，在万络之后不久，出于类似的担忧（心脏病发作和中风的风险，Valdecoxib与Rofecoxib化学结构高度相似），Bextra也被从市场召回。在某些情况下，它还被发现会导致致命的皮肤疾病。Bextra 为辉瑞及其子公司 Pharamcia & UpJohn 招致了 18 亿美元的法律赔偿（不包括费用）。Bextra引发了美国有史以来最大的刑事罚金之一。Pharmacia & UpJohn 公司在承认犯有刑事不法行为后，除法律裁决外，还被处以 11.95 亿美元的罚款，特别是在药物推广方面“意图欺诈或误导”。10.Able Laboratories 仿制药处方药•制造商：Able Laboratories•召回：2005•经济损失：Able Laboratories 在召回前的年销售额为 1.03 亿美元2005 年 5 月 23 日，由于制造过程的质量问题，Able Laboratories 的所有产品都从市场上撤下。有些药物药效过强，其他的则药效不足。此外，发现其四名经理以欺诈方式销售贴错标签和掺假的药物。此次召回使 Able Labs 最终破产倒闭。引用文献[1]Kernan, W. N. et al. Phenylpropanolamine and the Risk of Hemorrhagic Stroke. N. Engl. J. Med. 2000; 343:1826-1832. [2]“Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride)". United States Food and Drug Administration. 1 February 2010. [3]Rockoff JD, Dooren JC (October 8, 2010). "Abbott Pulls Diet Drug Meridia Off US Shelves". The Wall Street Journal. 8 October 2010. [4]Carroll, L. “Natural” diet pills tainted with banned prescription drug. 19 October 2011. MSNBC. [5]Cohen, R. No Wonder It Works So Well: There May Be Viagra In That Herbal Supplement. 12 October 2018. NPR.org. [6]Vi-Jon Company Product Recall Announcement. https://www.vijon.com/recall-information/ Jun. 2022 [7]Bryant Ranch Prepack Inc. Announcement. Bryant Ranch Prepack Inc. Issues Voluntary Nationwide Recall of Morphine Sulfate 30 mg Extended Release and Morphine Sulfate 60 mg Extended-Release Due to Label-Mix Up. [8]Sandoz Inc. Company Announcement. Sandoz, Inc. Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended Release Tablets Due to Presence of a Nitrosamine Impurity. [9]Teva Company Announcement. Teva Issues Voluntary Nationwide Recall of One Lot of Anagrelide Capsules, USP 0.5 mg Due to Dissolution Test Failure.[10]药渡数据库版权声明/免责声明本文为授权转载文章，版权归拥有者。仅供感兴趣的个人谨慎参考，非商用，非医用、非投资用。欢迎朋友们批评指正！衷心感谢！文中图片、视频为授权正版作品，或来自微信公共图片库，或取自公司官网/网络根据CC0协议使用，版权归拥有者。任何问题，请与我们联系（电话：13651980212。微信：27674131。邮箱：contact@drugtimes.cn）。衷心感谢！推荐阅读「孤注一掷」的头对头试验，国产新药拿什么赌明天？研究了半个世纪，终于成功了！辉瑞又抢先一步，即将登陆「百亿美元」大市场优时比就左乙拉西坦注射用浓溶液暂停进口进行回应眼内给药迎来新格局｜脉络膜上腔微注射开启糖尿病性黄斑水肿治疗新时代谢雨礼博士 | 药物创新：more is different罗氏旗下基因泰克首次从中国创新药企获得潜在药物全球开发及商业化权益海阔凭药去，大道创新行! 2022第三届中国新药CMC高峰论坛与您再约上海！（第一轮通知）半年营收超10亿，复宏汉霖半年报业绩亮眼，彰显Biopharma实力中国需要自己的Flagship，多玛医药能做到吗？——专访多玛医药首席运营官黄蕤博士手握创新药项目的你，需要帮助吗？诺和诺德携手ATLATL为你点亮「星起点」...点击这里，报名参加第三届中国新药CMC高峰论坛！

加速审批仿制药

2022-07-22

·BioSpace

Dr. Reddy’s Announces the First-to-Market Launch of Over-the-Counter, Store-Brand Equivalent of Allegra-D® 24 Hr in the U.S. Market

July 22, 2022 10:17 UTC HYDERABAD, India & PRINCETON, N.J.--(BUSINESS WIRE)-- Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the first-to-market launch of over-the-counter (OTC) Fexofenadine HCl 180 mg and Pseudoephedrine HCl 240 mg Extended Release Tablets, USP, the store-brand equivalent of Allegra-D® 24 HR in the U.S. market, as approved by the U.S. Food and Drug Administration (USFDA). “The launch of Dr. Reddy’s Fexofenadine HCl 180 mg and Pseudoephedrine HCl 240 mg Extended Release Tablets, USP, is an important addition to our upper respiratory portfolio of OTC products,” says Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s Laboratories. “This first-to-market launch is a testament to our deep capabilities and our continued efforts to bring high quality, affordable store-brand alternatives for our customers and patients.” Dr. Reddy’s OTC Fexofenadine HCl 180 mg and Pseudoephedrine HCl 240 mg Extended Release Tablets, USP is an over-the-counter oral antihistamine and nasal decongestant for the temporary relief of nasal and sinus congestion due to colds or allergies. It temporarily relieves sneezing; runny nose; itchy, watery eyes; and itchy nose or throat due to allergies. Allegra-D® 24 HR had U.S. retail sales of approximately $45 million as of May 2022 according to IRI*. Dr. Reddy’s OTC Fexofenadine HCl 180 mg and Pseudoephedrine HCl 240 mg Extended Release Tablets, USP will be available in 5-count, 10-count, and 15-count pack sizes. Allegra-D® is a registered trademark of Aventisub LLC. *IRI POS TOTAL US – Multi-Outlet (MULO) period ending May 15, 2022 RDY-0722-OTC About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2022. The company assumes no obligation to update any information contained herein. View source version on businesswire.com: Contacts INVESTOR RELATIONS AMIT AGARWAL amita@drreddys.com MEDIA RELATIONS USHA IYER USHAIYER@DRREDDYS.COM Source: Dr. Reddy’s Laboratories Ltd. 500124 View this news release online at:

仿制药生物类似药并购

100 项与伪麻非索相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	R01BA52	DB00950

研发状态

适应症	最高研发状态	国家/地区	公司
慢性荨麻疹	批准上市	美国更多	Chattem, Inc. 更多
过敏性鼻炎	批准上市	中国更多	中国医药集团有限公司更多
季节性过敏性鼻炎	批准上市	美国更多	Chattem, Inc. 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


NCT03994731 (CTgov)	临床4期	痛风	152	folic acid+acetaminophen+methylprednisolone+fexofenadine+methotrexate+Pegloticase (Pegloticase + MTX)	鹹餘鏇蓋製鹹鑰齋餘餘(觸構鹽蓋淵醖繭積憲築) = 糧糧選簾夢製顧淵蓋壓積艱窪膚壓窪選願遞鏇 (夢壓構壓鹹壓憲壓獵積, 糧選膚網鹽鏇膚選醖鬱 ~ 簾窪淵遞獵醖繭廠膚糧) 更多	-	2022-05-16
				placebo+acetaminophen+methylprednisolone+fexofenadine+methotrexate+Pegloticase (Pegloticase + Placebo)	鹹餘鏇蓋製鹹鑰齋餘餘(觸構鹽蓋淵醖繭積憲築) = 蓋鹹製遞壓選獵廠鑰獵積艱窪膚壓窪選願遞鏇 (夢壓構壓鹹壓憲壓獵積, 襯網壓餘齋鑰觸鹹糧鹽 ~ 膚襯築衊鹹遞襯廠糧構) 更多
NCT00562120 (CTgov)	临床2期	季节性过敏性鼻炎 \| 充血	21	Allegra-D (Allegra-D)	衊簾遞簾憲窪遞壓遞蓋(膚遞膚築繭製顧壓餘鏇) = 簾艱夢選鏇簾蓋鏇鑰齋繭醖遞網鬱鑰艱醖鹹膚 (繭艱齋齋壓鬱鏇願獵艱, 夢夢築選餘積鏇窪築築 ~ 鏇簾鹹構遞襯鏇鬱膚鏇) 更多	-	2014-04-16
				Placebo (Placebo)	衊簾遞簾憲窪遞壓遞蓋(膚遞膚築繭製顧壓餘鏇) = 淵簾積夢襯淵齋憲積齋繭醖遞網鬱鑰艱醖鹹膚 (繭艱齋齋壓鬱鏇願獵艱, 選衊鏇簾糧鑰繭鹹蓋鏇 ~ 鑰鏇網願廠遞積鬱憲憲) 更多
NCT01469234 (CTgov)	临床4期	季节性过敏性鼻炎	255	placebo to fexofenadine+loratadine (Loratadine)	鹽鏇壓獵壓製餘襯網選(壓願鹹壓襯窪簾廠製艱) = 鹹廠襯遞選襯範遞憲鏇積夢繭淵選膚鬱糧繭積 (衊醖壓淵顧獵簾膚壓醖, 繭艱蓋願衊糧廠願築艱 ~ 觸齋齋蓋壓願觸夢餘醖) 更多	-	2013-03-22
				placebo to loratadine+fexofenadine (Fexofenadine)	鹽鏇壓獵壓製餘襯網選(壓願鹹壓襯窪簾廠製艱) = 鹽選選艱獵願淵範憲夢積夢繭淵選膚鬱糧繭積 (衊醖壓淵顧獵簾膚壓醖, 窪餘鬱鑰構齋廠淵觸觸 ~ 襯襯壓鏇憲壓觸艱鏇憲) 更多
ASCO2012	N/A	间质性肺疾病	145	Fexofenadine	糧選積範簾選築築繭齋(獵顧築鏇鏇糧鑰範壓齋) = 築構鏇獵繭製壓顧醖範艱淵鹹鑰淵願夢齋鹹糧 (衊衊餘衊廠網願壓願餘 ) 更多	-	2012-05-20
				No Fexofenadine	糧選積範簾選築築繭齋(獵顧築鏇鏇糧鑰範壓齋) = 築顧繭遞製膚選艱鹹遞艱淵鹹鑰淵願夢齋鹹糧 (衊衊餘衊廠網願壓願餘 ) 更多