Prostate Enucleation With Intravesical Botox Injections in Treating Benign Prostatic Hyperplasia and Bladder Overactivity : A Randomized Controlled Trial

The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during Bipolar prostate enucleation surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB).

开始日期2025-01-01

申办/合作机构

Menoufia University

NCT05393921 / Not yet recruiting临床4期IIT

The Clinical Efficacy of Intravesical Botox Injections When Combined With HoLEP Surgery in Patients With Benign Prostatic Hyperplasia and Overactive Bladder

Benign prostatic hyperplasia (BPH) is the most common benign neoplasm in men. Almost 90% of men in their 70s report lower urinary tract symptoms related to BPH. These symptoms carry a significant negative impact on the patients' quality of life.
Despite the wide availability of surgical offerings to relieve bladder outlet obstruction such as transurethral resection of the prostate (TURP), Holmium Laser Enucleation of the Prostate (HoLEP), and prostatectomy, many patients still suffer from persistent LUTS after undergoing these. A study describing postoperative outcomes following HoLEP revealed that patients with severe lower urinary tract symptoms, storage-positive sub-score, and high maximum urinary flow rate before the surgery were affected by a rebound of mainly storage symptoms 6-8 weeks after HoLEP and prolonged recovery from LUTS with 7.4% of them presenting for persistent urge complaints.
Optimizing the management approach for these patients has been limited by lack of high level evidence-based recommendations and expert consensus. Intravesical botox injections are well-established therapeutic options for several urinary disorders. The current practice offers intravesical botox injections to patients who suffer from persistent urinary symptoms few months after their BPH procedure. This study aims to evaluate if giving botox injections at the time of the HoLEP surgery would yield a better outcome than performing the two procedures separately at different times (few months apart).
The concomitant use of botox injection during bladder de-obstructing procedures has been previously studied in TURP and have showed a significant reduction of incontinence episodes and OAB symptoms in the group that were treated with botox injections after 36 weeks post TURP. This data may suggest promising potential of this intervention in managing persistent OAB symptoms in patients with BOO. However, the efficacy of combining HoLEP and bladder Botox injections has not been systematically studied and evaluated.
The aim of this study is to evaluate the effect of intravesical Botox injections on lower urinary tract symptoms (LUTS) when administered during HoLEP surgery in patients with bladder outlet obstruction (BOO) and overactive bladder symptoms (OAB). The investigators are interested in comparing the postoperative outcome in terms of recovery and symptom relief in patients who performed HoLEP surgery with bladder Botox injections versus those who performed HoLEP surgery only at 2 weeks,1 month, 3 months, and 6 months postoperatively.
The investigators hypothesize that administering bladder botox injections during HoLEP surgery is a combination treatment that will result in faster and more potent symptom relief compared to patients who received only a HoLEP surgery for their obstructive and irritative symptoms.

开始日期2024-11-30

申办/合作机构-

NCT06293300 / Not yet recruiting临床2期IIT

Understanding and Treating TBI Associated Photophobia With Botulinum Toxin Type A and Its Impact on Visual Function

The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.

开始日期2024-08-01

申办/合作机构

University of Miami

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100 项与 A型肉毒毒素相关的临床结果

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100 项与 A型肉毒毒素相关的转化医学

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100 项与 A型肉毒毒素相关的专利（医药）

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2,231

项与 A型肉毒毒素相关的文献（医药）

2024-05-01·American journal of otolaryngology

Use of botox for sialorrhea and dysphagia in the neonatal population

Article

作者: Haykal, Nadine ; McCoy, Jennifer L ; Tobey, Allison B J ; Lu, Nathan

INTRODUCTION:

Botox is frequently used for sialorrhea in patients with compromised airways and those with etiologies causing difficulty with secretion management (i.e. strokes, neurologic disorders, etc.). There are no published studies regarding the use of botulinum toxin (BoNT) in the neonate population. We aim to discuss our experience and safety of BoNT use in the neonate population in regards to alleviating secretion management and airway protection.

METHODS:

Retrospective review of neonates admitted to the neonatal intensive care unit (NICU) ≤12 months of age who received BoNT injection to submandibular (SMG) and parotid (PG) glands for sialorrhea/dysphagia. BoNT was administered under ultrasound (u/s) guidance by interventional radiology.

RESULTS:

6 children were examined. 2 (33 %) were male. Avg NICU stay was 87.5 ± 33.1 days. 2 underwent surgical airway intervention prior to injection. Mean age at initial BoNT was 1.5 ± 0.7 months. Avg weight at injection was 4 ± 1.1 kg. Each PG and SMG were injected in 5/6 cases. Bilateral SMG were unidentified on u/s in 1 case and thus not injected. Dose range injected per gland was 5-15u. 100 % required tube feeds, 50 % with tubes distal to stomach (NJT/NDT). 83 % were completely NPO prior to injection and there was no noted clinical improvement in oral skills post injection. All had noted desats/apneas prior to injection and 83 % had reported decreased events post injection. 50 % had reported decrease O2 requirements and frequent suctioning 2wks after injection, however 2 (33 %) required surgical airway intervention after injection (trach, SGP/MDO). 4/6 (67 %) trialed medical therapy, anticholinergics being the most common. 50 % underwent 2nd injection (age = 6.5 ± 0.3 months) avg. 4.7 ± 0.7mo after 1st injection, and the same 3pts underwent 3rd injection (age = 12.5 ± 2.4 months) avg. 6.1 ± 2.5mo after 2nd injection. 1 pt. had a total 6 injections. There were no injection related complications.

CONCLUSION:

BoNT injection is a safe, non-invasive alterative for management of sialorrhea in neonates. Further extensive study needs to be performed to identify the optimal dose per gland in this population.

2024-03-01·Journal of plastic, reconstructive & aesthetic surgery : JPRAS

Ocular-oral synkinesis caused by partial injury of the zygomatic and buccal branches of the facial nerve after mid-face trauma

Article

作者: Jun, Dongkeun ; Kim, Jin ; Park, Il-Seok

BACKGROUND:

Facial nerve paralysis induced by acute traumatic facial nerve injuries limited to the zygomatic and buccal branches shows unique complications, such as strong co-contractions of the lower facial muscles around the lips during voluntary blinking (ocular-oral synkinesis). We investigated the characteristics of facial complications after facial nerve injury in the mid-face area and reported the treatment results.

METHODS:

A total of 21 patients with facial nerve injuries to the zygomatic and/or buccal branches were evaluated for the degree of facial synkinesis and mouth asymmetry. Patients with mild-to-moderate symptoms were treated using physical rehabilitation therapy combined with botulinum toxin (Botox) injection, and patients with severe or uncontrolled symptoms were treated using surgical therapy.

RESULTS:

Initial/final mean synkinesis scores and mouth asymmetry degrees were 2.17/1.75 and 0.85/0.66 in the physical therapy group and 3.11/0.78 and 2.41/-0.31 in the surgery group, respectively. Physical therapy with Botox injection alone did not show significant improvements in synkinetic symptoms of the patients with mild-to-moderate synkinesis (p > 0.05), whereas surgical therapy resulted in significant improvements in synkinesis and mouth asymmetry (p < 0.05).

CONCLUSIONS:

Surgical treatment is an effective adjustment procedure for the management of facial complications in patients with severe or uncontrolled synkinesis after facial nerve injury to the mid-face area.

2024-02-01·Journal of the World federation of orthodontists

Orthodontic considerations in hypodivergent craniofacial patterns

Article

作者: Park, Jae Hyun ; Liaw, Johnny J L

This article examines the characteristics of hypodivergent craniofacial patterns and explores treatment modalities in response to these features. It discusses the impact of robust masticatory muscles, which produce heavy occlusal forces. In addition, it examines the use of Botox or splints to reduce gonial angles in individuals with a square face. A nonextraction treatment approach supported by temporary skeletal anchorage devices is recommended; however, if anatomical limitations persist, extraction may be necessary when arch expansion, molar distalization, incisor proclination, or interproximal reduction cannot create the necessary space. In hypodivergent cases where a nonextraction approach is impractical, a single-arch extraction strategy may be considered to prevent a reduction in the vertical dimension. Emphasizing esthetics, particularly maxillary incisor display, a protocol of total arch extrusion of the maxillary dentition assisted with temporary skeletal anchorage device, bite raisers, and interarch elastics is suggested.

286

项与 A型肉毒毒素相关的新闻（医药）

2024-06-27

·药渡Daily

绿叶制药不按套路出牌

传统药企的转型路径各式各样，其中绿叶制药选择了中枢神经系统（CNS）赛道，而且迎来了收获期。半个月不到，绿叶制药就在国内接连获批了2款CNS药物，一是治疗精神分裂症的美比瑞（棕榈酸帕利哌酮注射液），二是全球首个治疗帕金森病长效微球制剂金悠平（注射用罗替高汀微球）。此外，在阿尔茨海默病和抑郁症领域，绿叶制药近年来也有相应产品获批上市，甚至成功出海。不难看出，绿叶制药开辟的CNS新战场已经看到了曙光。 01 强化CNS产品线，绿叶制药新获批的这两款CNS药物，究竟能不能打？ 6月11日，绿叶制药自研的第二代抗精神病药长效针剂棕榈酸帕利哌酮注射液（美比瑞）获得国家药监局批准上市，用于精神分裂症急性期和维持期的治疗。精神分裂症是一种慢性、高复发和高致残性疾病，目前治疗手段主要以口服药物为主，分为第一代、第二代和第三代，其中第二代药物由于安全性和疗效更好，占据市场最大份额，已获批药物包括奥氮平、帕利哌酮、阿立哌唑等。不过，口服药物的痛点在于患者需每日给药，常常出现中断治疗或自行减药而导致病情反复的情况。而长效针剂相比口服剂型可显著改善患者的依从性。绿叶制药的美比瑞，是每月给药一次的棕榈酸帕利哌酮长效针剂，极具依从性优势，其活性成分帕利哌酮是精神分裂症治疗的一线用药，具有良好的改善精神分裂症阳性症状、阴性症状、情感症状和认知功能的作用。从市场前景看，精神分裂症患者人数庞大，在全球约有2400万名患者，中国占了全球患者总数的1/3，高达约800万名患者。根据IQVIA数据显示，2023年全球抗精神病药长效针剂市场规模约为80亿美元，其中帕利哌酮长效针剂销售额超过50亿美元。除抗精神分裂药物外，帕金森病也是CNS领域的“必争之地”。一则，患者人数庞大，中国约有超过300万名帕金森病患者，预计到2030年将增至500万人；二则，由于当前的药物或手术治疗均以改善症状为主，不能阻止病情的发展，更无法治愈，导致帕金森病领域存在庞大的临床未满足需求。因而，临床提倡早诊早治和长期管理，以更好地改善症状，包括罗替高汀在内的非麦角类多巴胺受体激动剂（DAs）是早发型帕金森病患者病程初期的首选药物。 6月20日，绿叶制药研发的金悠平——注射用罗替高汀缓释微球（LY03003）获NMPA批准上市，用于治疗帕金森病。金悠平是全球首个治疗帕金森病的长效缓释微球制剂，每周给药一次，也是目前更符合“持续多巴胺能刺激（CDS）”理念的周制剂。与当前已上市的、需要每日给药的DAs药物相比，金悠平克服了短效DAs药物产生的非生理性的脉冲式刺激，显示出明显的缓释制剂特征，7天内可维持稳定的罗替高汀释放，保持稳定的血药浓度和连续多日的持续疗效，从而真正实现CDS，减少药物浓度波动导致的症状波动以及不良反应。而且，每周一次的给药频率有助于提升患者依从性，更利于长期管理。 02 为何开辟CNS新战场？ CNS领域是绿叶制药近年来的重要发力点，打造了多个技术平台：新型制剂技术平台、新分子实体技术平台、生物抗体平台等，其中新型制剂技术平台包括长效及缓释技术、脂质体与靶向给药技术、透皮释药技术。可以看到，不同于一些国内药企争相抢占仿制药的常规策略，绿叶制药选择深耕高端剂型，走出了一条剂型或结构改良的微创新道路。基于这些技术平台，绿叶制药在CNS领域打造了一系列产品，除了前文所述的美比瑞、金悠平以外，还包括Rykindo（利培酮缓释微球注射剂）、若欣林（盐酸托鲁地文拉法辛缓释片）、思瑞康（富马酸喹硫平片）及其缓释片、治疗阿尔茨海默病的利斯的明透皮贴剂（单日贴及多日贴）等，业务覆盖全球80多个国家和地区，包括中美日和欧洲在内的主要医药市场以及更多高潜力国际新兴市场。其中，Rykindo（瑞可妥）是中国首个在美获批的治疗精神分裂症的CNS新药，若欣林是中国首个自研并拥有自主知识产权用于治疗抑郁症的化药1类创新药。凭借丰富的产品组合，2023年绿叶制药实现CNS产品销售收入约13.9亿元，同比增长14%，占公司总产品销售收入比重约24.7%。但这还不是终点，在CNS领域，绿叶制药还有治疗迟发性运动障碍的VMAT2抑制剂（LY03015）等多个新药在中国及海外市场同步开发。绿叶制药CNS领域在研产品线图片来源：公司官网绿叶制药选择开辟CNS新战场，在于这一领域患者人数庞大，是中国第四大药品市场。例如，若欣林针对的抑郁症，影响着全球近3亿人，其中中国约有5000万名需要规范用药治疗的患者，使得若欣林在上市第一年就实现迅速销售，成为中国CNS领域增长最快的新药，绿叶制药预计该药将成为销售潜力达数十亿元的畅销产品；瑞可妥针对的精神分裂症、躁郁症，在全球分别影响约2400万人、4000万人，同样有着巨大的商业价值。值得一提的是，今年4月，专注长效缓释制剂技术的法国制药公司Medincell，获全球制药巨头艾伯维超19亿美元押注，双方共同开发和商业化6款长效制剂。 Medincell专有的长效制剂技术（BEPO）可以控制和保证药物在几天、几周甚至几个月内以最佳治疗剂量定期给药。MNC巨头的押注，无疑佐证了长效制剂在CNS领域的应用潜力。去年4月，Medincell和梯瓦共同开发的利培酮缓释注射混悬液Uzedy获FDA批准上市，成为利培酮的第一个皮下长效制剂，每隔1到2个月注射一次。Uzedy正是基于MedinCell的BEPO技术进行开发。 03 MNC重金押注CNS领域艾伯维在神经科学领域的布局还不止于此。神经科学领域是艾伯维除免疫学以外的第二大收入来源，2023年贡献收入约77.2亿美元，同比增长18.2%，是去年唯一实现正增长的业务板块。其中，3款偏头痛药物Botox、Ubrelvy、Qulipta分别实现销售额29.91亿美元、8.15亿美元、4.08亿美元，精神分裂症药物Vraylar、帕金森病药物Duodopa实现收入27.59亿美元、4.68亿美元，同比增长35.4%、2.3%。随着免疫学板块的“药王”Humira（修美乐）专利到期、业绩承压，艾伯维迫切需要新的业务线填补，神经科学领域的价值尤为重要。为此，艾伯维去年斥资87亿美元收购Cerevel Therapeutics，囊括了一系列治疗精神分裂症、帕金森病和情绪障碍等多种疾病的潜在候选药物。除艾伯维外，近年来入局CNS领域的全球制药巨头也不在少数。例如，2022年，辉瑞斥资116亿美元收购Biohaven，拿下偏头痛口服CGRP抑制剂Rimegepant；去年11月，默沙东以6.1亿美元收购Caraway Therapeutics，布局退行性神经疾病；百时美施贵宝（BMS）更是豪掷140亿美元收购Karuna，拿下精神分裂症药物KarXT。 Rimegepant于2020年获FDA批准用于成人急性偏头痛的治疗，2023年销售额达9.28亿美元，相比2022年翻了4倍有余。辉瑞曾预测，Rimegepant年销售额峰值将达到60亿美元。 KarXT作为M1/M4毒蕈碱受体口服小分子激动剂，是治疗精神分裂症的全新靶点，已经向FDA提交上市申请，PDUFA日期为2024年9月25日，有望成为近几十年来首个用于治疗精神分裂症的新机制药物。 Evaluate预测，到2028年KarXT销售额可达到28亿美元。甚至有分析师认为，如果KarXT后续能扩大适应症范围，包括用于阿兹海默病患者的精神病治疗，销售峰值年营收可达60亿美元。正是由于CNS领域具备大药潜质，吸引了绿叶制药、众多MNC巨头入局，此外还有另一家拥有微球技术平台的丽珠集团/丽珠医药，以及东阳光药、华海药业、石药集团等国内药企。在抗抑郁症药物领域，国内药企布局了多款1类新药，包括东阳光药的磷酸嘧替佐酮片（II/III期临床）、广为医药的GW117片剂（II期临床）、华海药业的盐酸羟哌吡酮、豪森药业/翰森制药的HS-10353（II期临床）、信立泰的SAL0114片（I/II期临床）、石药集团的新型SNRIs类药物盐酸阿姆西汀肠溶片。 04 结语这几年，随着改良型新药、新机制药物的接连突破，CNS领域的市场空间不断被打开，同时也给入局CNS领域的绿叶制药带来了更大的想象空间。当然，药物获批还不是终点，绿叶制药能否证明自己、验证商业价值，还需CNS治疗产品商业化的兑现。参考资料 1.各家公司的财报、公告、官微 2.兴业证券、招商证券研报

上市批准临床研究

2024-06-21

·生物谷

Journal of Advanced Research：连翘苷A通抑制肺和结肠炎症及上皮屏障损伤减轻急性肺损伤

研究表明，连翘苷A在ALI治疗过程中，通过调控PAR-c/RXR-a复合物发挥细胞特异性作用，抑制炎症，减轻肺和结肠上皮屏障损伤。急性肺损伤(ALI)和急性呼吸窘迫综合征(ARDS)是公认的以弥漫性炎性细胞浸润、出血和肺水肿为特征的肺部疾病。可导致ALI/ARDS的直接和间接因素包括吸入、肺炎、败血症、创伤、胰腺炎和输血等。许多研究表明，炎症在ALI/ARDS的发病机制中起关键作用。具体地说，大量的免疫细胞聚集在损伤部位，启动一系列炎症信号转导，释放过量的促炎细胞因子。随后，炎症破坏了肺泡上皮和血管内皮细胞的屏障功能，增加了肺泡毛细血管膜的通透性。这会导致富含蛋白质的水肿液积聚到肺间质中，最终导致肺水肿和组织损伤。目前，除机械通气外，药物干预仍是ALI/ARDS的主要治疗方法。皮质类固醇具有广泛的抗炎活性，被认为是治疗ALI/ARDS的理想药物。然而，皮质类固醇的应用受到许多不良反应的限制，如肌肉无力、身体功能受损、过敏反应和神经认知功能障碍。因此，需要在治疗方法和药物方面为ALI提供额外的支持。图片来源：https://doi-org.libproxy1.nus.edu.sg/10.1016/j.jare.2023.08.006 近日，来自成都中医药大学的研究者们在Journal of Advanced Research杂志上发表了题为“Forsythiaside A alleviates acute lung injury by inhibiting inflammation and epithelial barrier damages in lung and colon through PPAR-c/RXR-a complex”的文章，该研究揭示了连翘苷A通过PPAR-c/RXR-a复合体抑制肺和结肠炎症及上皮屏障损伤减轻急性肺损伤。急性肺损伤(ALI)是一种以炎症为特征的肺部疾病，仍需要进一步的药物开发。连翘苷A是连翘中的活性成分，具有治疗ALI的潜力。本研究目标是从肠肺轴角度探讨连翘苷A通过PPAR-c及其结合物RXR-a治疗ALI的机制。本研究利用脂多糖和肿瘤坏死因子-α建立了体外和体内损伤模型。药物处理采用连翘苷A，RXR-a抑制剂UVI3003干扰细胞内PPAR-c/RXR-a复合体。组织病理学检查采用HE染色。用微量试剂盒检测血清内毒素含量。免疫组织化学染色和Western印迹法检测蛋白表达。采用ELISA法检测细胞培养上清液中促炎症细胞因子的含量。通过CO-IP分析蛋白质间的相互作用。连翘苷A对脂多糖诱导的急性肺损伤小鼠肺和结肠炎症的影响图片来源：https://doi-org.libproxy1.nus.edu.sg/10.1016/j.jare.2023.08.006 体内实验结果表明，连翘苷A可调节PPAR-c/RXR-a，抑制TLR4/MAPK/NF-Jb和MLCK/MLC2信号通路，从而抑制气管内毒素诱导的ALI小鼠肺和结肠的炎症和上皮屏障损伤。PPAR-c/RXR-a在肺中被连翘苷A促进，而在结肠中被连翘苷A抑制。此外，体外实验结果表明，连翘苷A通过调控PPAR-c/RXR-a抑制脂多糖和肿瘤坏死因子-α诱导的TLR4/MAPK/NF-JB和NF-JB/MLCK/MLC2信号通路的激活，从而抑制巨噬细胞和肺/结肠上皮细胞的炎症和上皮屏障损伤。进一步的机制研究表明，连翘苷A对PPAR-c/RXR-a复合体具有细胞特异性调节作用。在脂多糖诱导的巨噬细胞RAW264.7和肿瘤坏死因子-α诱导的肺上皮细胞A549中，连翘苷A可促进PPAR-c/RXR-a蛋白相互作用，而在肿瘤坏死因子-α诱导的结肠上皮细胞SW620中，连翘苷A可抑制PPAR-c/RXR-a蛋白的相互作用。在ALI的治疗中，连翘苷A通过对PPAR-c/RXR-a复合体的调节，抑制肺和结肠的炎症和上皮屏障损伤。机制总结图图片来源：https://doi-org.libproxy1.nus.edu.sg/10.1016/j.jare.2023.08.006 总之，本研究的主要结果如下：(1)连翘苷A(Ⅰ)可调节PPAR-c/RXR-a复合体的活性，抑制TLR4/MAPK/NF-JB和MLCK/MLC2信号通路的活性，抑制脂多糖诱导的ALI小鼠肺和结肠的炎症反应和上皮屏障的损伤。连翘苷A还能促进肺组织中PPAR-c/RXR-a复合物的表达，抑制结肠组织中PPAR-c/RXR-a复合物的过表达; (2)连翘苷A可以调节PPAR-c/RXR-a复合物抑制LPS和tnf -a诱导的TLR4/MAPK/NFjB和NF-jB/MLCK/MLC2信号通路的激活，从而抑制巨噬细胞和肺/结肠上皮细胞的炎症和上皮屏障损伤; (3)连翘苷A对不同细胞的PPAR-c/RXR-a复合物具有细胞特异性调控作用。具体来说，它促进了PPAR-c/RXR-a在lps诱导的巨噬细胞RAW264.7和tnf诱导的肺上皮细胞A549中的蛋白相互作用，而抑制了tnf -a诱导的结肠上皮细胞SW620中的蛋白相互作用。综上所述，连翘苷A在ALI治疗过程中，通过调控PAR-c/RXR-a复合物发挥细胞特异性作用，抑制炎症，减轻肺和结肠上皮屏障损伤。（生物谷 Bioon.com）参考文献: Jing Wang et al. Forsythiaside A alleviates acute lung injury by inhibiting inflammation and epithelial barrier damages in lung and colon through PPAR-c/RXR-a complex. J Adv Res. 2024 Jun:60:183-200. doi: 10.1016/j.jare.2023.08.006.

免疫疗法

2024-06-20

·FiercePharma

No sweat for dermatology specialist Botanix as hyperhidrosis gel Sofdra gains FDA approval

Hyperhidrosis is the third largest dermatology market behind acne and atopic dermatitis, according to Botanix. Everybody sweats, but for the 10 million people in the U.S. living with primary axillary hyperhidrosis, sweating can take on a whole new meaning. The condition is hallmarked by sweating beyond the level necessary to regulate body temperature. Primary axillary hyperhidrosis specifically refers to the underarms and has major effects on quality of life, potentially impacting patients' work productivity, social interactions and emotional well-being. It’s been years since a new treatment hit the market in this condition. With an FDA approval in hand, Botanix hopes its topical gel Sofdra can change the game. The drug won FDA approval to treat primary axillary hyperhidrosis in patients ages 9 and older. It’s the first and only new chemical entity cleared for the condition, Botanix said in a press release. Current treatment options include AbbVie’s Botox injections and different formulations of glycopyrrolate. Many of the marketed therapies aren’t as targeted as Sofdra so they can dry out other fluids, such as tears, saliva and even cause urinary retention, Botanix’s founder and board executive director, Matt Callahan, said in a recent interview. In two phase 3 studies that enrolled a total of 701 patients, the gel helped patients achieve clinically and statistically meaningful improvements from baseline levels in the Gravimetric Sweat Production scale and the Hyperhidrosis Disease Severity Measure-Axillary score, according to the company's release. Reaching the roughly 10 million U.S. patients with primary axillary hyperhidrosis will require a unique commercial approach for Botanix, especially considering that fewer than half of patients have an official diagnosis, according to the company. Bearing in mind the social challenges the condition presents, many patients may be actively searching online to find a treatment, as opposed to visiting the dermatologist’s office, Callahan said. Botanix will reach these patients through a “very strong digital approach” that includes a telemedicine component. “This is kind of one of those areas where people don't like to talk about it much and dermatologists don't seem to know much about it,” Callahan explained. “So we're trying to solve that problem with a telemedicine approach to provide a better service and a better fulfillment option to these patients.” Still, the large patient population makes for a “massive opportunity” for Botanix, the executive said. Sofrda is the Australia-based company’s first commercial product. It will come with a price tag “on par” with other treatments on the market, but the key difference, Callahan said. Prescription wipe Qbrexza has an average retail price of $771, according to GoodRx. Considering 90% of those with hyperhidrosis also suffer from excessive sweating in other areas of the body, there is “lots of future potential” from a label expansion perspective, Callahan noted. Callahan says Botanix is something of a “hidden gem” on the Australian Stock Exchange, but the drugmaker plans to become “the next big dermatology company in the U.S.," he added. Its U.S. operations are based in Pennsylvania and Arizona, and the company is also working on treatments for acne and rosacea. The approval makes for a “transformative event” for the company as it transitions “from a development stage to a revenue-generating dermatology company,” CEO Howie McKibbon, M.D., added in Botanix's release. The drugmaker will roll out initial doses through an early patient experience program during this year’s third quarter. The wider launch is expected to take off during the fourth quarter.

临床3期上市批准临床结果

100 项与 A型肉毒毒素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08957	A型肉毒毒素	M03AX01	DB00083

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
咀嚼肌肥大	中国	Allergan, Inc.	2024-06-03
神经源性逼尿肌过度活动	美国	AbbVie, Inc.	2022-08-22
尿失禁	美国	AbbVie, Inc.	2022-08-22
发声困难	日本	GSK Plc	2018-05-25
额头皱纹	美国	AbbVie, Inc.	2017-10-02
膀胱功能障碍	美国	AbbVie, Inc.	2017-04-04
外眦皱纹	美国	AbbVie, Inc.	2013-09-11
上下肢痉挛	美国	AbbVie, Inc.	2010-03-09
马蹄状畸形	日本	Allergan, Inc.	2009-01-21
多汗症	日本	Allergan, Inc.	2009-01-21
偏头痛	日本	-	2009-01-21
神经性膀胱功能障碍	日本	Allergan, Inc.	2009-01-21
膀胱过度活动症	日本	Allergan, Inc.	2009-01-21
原发性颈性肌张力障碍	日本	GSK Plc	2005-10-03
肌肉痉挛	-	Genesis Healthcare, Inc.	2005-10-03
原发性腋窝多汗症	美国	AbbVie, Inc.	2004-07-19
斜视	美国	AbbVie, Inc.	2004-07-19
眼睑痉挛	中国	Allergan Pharmaceuticals Ireland ULC	2003-04-22
肌痛性痉挛	中国	Allergan Pharmaceuticals Ireland ULC	2003-04-22
斜颈	日本	GSK Plc	2000-06-20

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
头痛	临床3期	中国	葛兰素史克（中国）投资有限公司	2017-01-17
头痛	临床3期	中国	Allergan Pharmaceuticals Ireland ULC	2017-01-17
鱼尾纹	临床3期	中国	Allergan Pharmaceuticals Ireland ULC	2014-09-16
鱼尾纹	临床3期	中国	葛兰素史克（中国）投资有限公司	2014-09-16
脑瘫	临床3期	美国	Allergan Plc	2012-07-12
脑瘫	临床3期	加拿大	Allergan Plc	2012-07-12
脑瘫	临床3期	匈牙利	Allergan Plc	2012-07-12
脑瘫	临床3期	菲律宾	Allergan Plc	2012-07-12
脑瘫	临床3期	波兰	Allergan Plc	2012-07-12
脑瘫	临床3期	俄罗斯	Allergan Plc	2012-07-12

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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


NCT05248867 (CTgov)	临床3期	眉间纹	638	Placebo+AGN-151586 (Placebo)	鹽淵衊醖糧衊築艱鏇窪(衊艱築襯艱鑰網願衊窪) = 襯範觸繭鏇繭衊積積鬱艱鏇構範艱蓋遞鏇築鏇 (鹹廠衊構壓鹽遞襯顧範, 鑰遞構鹽繭廠鏇憲構鏇 ~ 繭淵蓋壓積獵鹽願艱積) 更多	-	2024-05-24
				AGN-151586 (AGN-151586)	鹽淵衊醖糧衊築艱鏇窪(衊艱築襯艱鑰網願衊窪) = 憲製顧糧繭糧鏇獵鹹築艱鏇構範艱蓋遞鏇築鏇 (鹹廠衊構壓鹽遞襯顧範, 鹽鏇艱齋選築餘醖遞選 ~ 廠獵夢廠壓觸膚遞蓋積) 更多
NCT03779841 (CTgov)	临床2期	心房颤动	323	Placebo (Placebo)	顧齋壓觸糧選遞膚選繭(齋網選築蓋夢鹽獵廠窪) = 淵鏇鏇選醖鑰壓選夢製獵鏇鏇願糧顧廠簾襯顧 (衊觸齋鏇積衊鑰獵廠鹽, 製獵網顧網願憲積簾範 ~ 遞鏇選襯簾憲觸齋壓範) 更多	-	2024-05-14
				AGN-151607 (AGN-151607 (125 U))	顧齋壓觸糧選遞膚選繭(齋網選築蓋夢鹽獵廠窪) = 積鏇襯窪齋顧遞築膚製獵鏇鏇願糧顧廠簾襯顧 (衊觸齋鏇積衊鑰獵廠鹽, 餘醖鏇襯鏇夢壓蓋製鏇 ~ 積鹽蓋糧選鬱繭夢獵壓) 更多
NCT05248867 \| NCT05248880 (M21-508, Corporate Publications) 人工标引	临床3期	眉间纹	947	TrenibotulinumtoxinE (BoNT/E)	觸築構顧憲顧製築蓋憲(鹽範選窪遞鏇顧艱襯衊) = 鬱願襯鬱窪襯膚襯遞廠膚遞觸糧糧鑰壓築鹹醖 (蓋糧選廠選觸衊願選選 ) 达到	积极	2023-10-24
				Placebo	-
CNS2023	临床2期	头痛	45	Onabotulinumtoxin A	鑰壓繭窪壓醖蓋淵淵簾(糧願淵範廠鹹鑰積衊蓋) = 鹽簾願衊繭築顧觸積簾觸積夢鏇醖衊繭淵糧鹹 (網糧積襯醖繭窪觸壓淵, 0 ~ 17) 更多	-	2023-10-01
NCT04994535 (M21-310, Corporate Publications) 人工标引	临床3期	颈阔肌突出	426	Onabotulinumtoxin A	簾選觸遞網鏇齋鹹艱範(淵獵選鹽網鏇製襯壓糧): P-Value = <0.0001 达到更多	积极	2023-09-18
				Placebo
NCT03137407 (CTgov)	临床2期	足底筋膜炎	59	Placebo (Placebo)	觸齋夢艱選廠鑰襯鹹築(選壓夢遞積積積壓醖窪) = 醖鏇夢艱鹹醖齋鹽鹽壓糧繭膚繭觸蓋願窪構積 (鑰願窪窪淵廠衊糧範製, 鹹繭願獵憲積遞鹽構醖 ~ 獵積構鑰窪顧憲鬱鏇顧) 更多	-	2023-08-28
				Botulinum Toxins, Type A (DAXI 240 U)	齋淵簾選糧繭醖構積鏇(廠蓋淵醖獵膚齋積襯觸) = 構願壓遞鏇範膚製糧襯鏇願鹽艱壓餘範壓鹹淵 (膚簾鬱窪艱餘簾窪襯鏇, 鹹鹽醖網夢選膚積範遞 ~ 構願齋廠壓糧構蓋遞築) 更多
NCT05127018 (CTgov)	临床1/2期	肉毒中毒	33	botulinum toxin type A+Botox (the First Injection(the Average-dose Method))	醖鏇艱膚製遞鏇壓衊鑰(願範簾鹹齋積憲鏇醖網) = 鹽淵觸蓋艱製齋鑰願齋廠網齋顧膚齋餘簾醖襯 (憲餘構獵艱鏇襯願觸觸, 築窪壓觸鏇遞鬱襯壓獵 ~ 鏇鬱鏇願觸網廠艱壓鏇) 更多	-	2023-04-26
				botulinum toxin type A+Botox (the Second Injection(the Higher-dose Method))	醖鏇艱膚製遞鏇壓衊鑰(願範簾鹹齋積憲鏇醖網) = 觸鹽願獵壓餘廠願鏇構廠網齋顧膚齋餘簾醖襯 (憲餘構獵艱鏇襯願觸觸, 醖蓋鏇廠壓簾糧窪簾鹹 ~ 鏇鏇選襯築廠願構觸築) 更多
AUA2023	N/A	神经性膀胱功能障碍	101	NLUTD patients receiving BTX-A	鹽觸觸膚餘觸衊窪餘網(遞積蓋範鏇鬱鬱網憲積) = 齋糧衊衊鹹遞餘構鏇窪壓齋鹹齋鏇壓廠遞糧觸 (壓糧網繭醖構願積憲築 ) 更多	-	2023-04-01
NCT03991299 (CTgov)	临床1/2期	非胰岛素依赖型糖尿病2 \| 体重下降 \| 肥胖	4	Botox 200 UNT Injection	觸製獵願顧範餘糧構範(醖選廠夢醖鑰襯蓋窪夢) = 選壓簾簾顧遞襯鑰醖襯醖築窪鑰餘顧餘鏇顧襯 (膚窪顧鏇選鏇壓衊鏇餘, 願餘夢鹽繭鑰鑰積鹽艱 ~ 網廠鑰襯構鬱繭範憲鏇) 更多	-	2023-02-28
AAO2022	N/A	良性基础型眼睑痉挛	-	OnabotulinumtoxinA	製衊簾網窪觸簾壓簾糧(構糧積網壓齋簾範願淵) = 糧醖選鏇襯範鹽窪艱鹹構艱餘窪選顧艱艱蓋壓 (窪醖鏇憲醖夢醖網淵壓 )	-	2022-09-29