更新于：2024-11-21

Alprazolam

阿普唑仑

更新于：2024-11-21

概要

概要

基本信息

简介阿普唑仑是一种小分子药物，可作为 GABAA 受体的激动剂，GABAA 受体是一种对抑制性神经递质γ-氨基丁酸 (GABA) 有反应的神经递质受体。通过增强 GABA 在大脑中的作用，阿普唑仑具有抗焦虑、镇静和抗惊厥的特性。这种药物主要用于治疗焦虑症和恐慌症。然而，它也被发现对某些癫痫和哮喘相关焦虑症有效。阿普唑仑于1981年10月16日首次获得FDA批准，由日本制药公司武田制药公司研制。阿普唑仑有多种形式，包括速释片和缓释片，以及口服溶液。应谨慎使用，因为它可能会导致依赖性和戒断症状。

药物类型

小分子化药

别名

8-Chloro-1-methyl-6-phenyl-4H-s-triazolo(4,3-a)(1,4)benzodiazepine、Alprazolcem

+ [17]

靶点

DOCK5 x GABAA receptor

作用机制

DOCK5抑制剂(dedicator of cytokinesis 5 inhibitors)、GABAA receptor激动剂(γ-氨基丁酸 A 受体激动剂)

治疗领域

神经系统疾病其他疾病

在研适应症

紧张症抑郁症入睡和睡眠障碍+ [4]

非在研适应症

药物滥用轻度哮喘恐慌

原研机构

Takeda Pharmaceutical Co., Ltd.Upjohn Pharmaceuticals Ltd.

在研机构

UCB Biopharma SRL

优时比贸易（上海）有限公司

Teva Takeda Pharma Ltd.初创企业

+ [5]

非在研机构

Viatris, Inc.

Engage Therapeutics, Inc.初创企业

UCB, Inc.

+ [3]

最高研发阶段批准上市

首次获批日期

美国 (1981-10-16),

焦虑症惊恐障碍

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (中国)

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结构

分子式C17H13ClN4

InChIKeyVREFGVBLTWBCJP-UHFFFAOYSA-N

CAS号28981-97-7

关联

110

项与阿普唑仑相关的临床试验

IRCT20240506061669N1 / Recruiting临床3期IIT

Comparing the effect of Alprazolam (single dose) and Clonidine on improving the patient's stability under General Anesthesia

开始日期2024-05-21

申办/合作机构

Islamic Azad University

CTR20241558 / CompletedN/A

阿普唑仑片在空腹及餐后条件下的人体生物等效性试验

本研究考察健康受试者在空腹及餐后条件下，单次口服由湖南洞庭药业股份有限公司生产的阿普唑仑片（受试制剂，规格：0.4 mg）或由ヴィアトリス製薬株式会社（Viatoris制药株式会社）持证的阿普唑仑片（参比制剂，商品名：Solanax®，规格：0.4 mg）的药动学特征，评价两制剂的生物等效性及安全性，该受试制剂一致性评价提供依据。

开始日期2024-05-14

申办/合作机构

湖南洞庭药业股份有限公司

NCT06293638 / RecruitingN/AIIT

Functional Brain Network Changes in Patients Undergoing Deep Brain Stimulation for Essential Tremor

The purpose of this study is to collect electrophysiological data related to functional brain network changes in patients undergoing deep brain stimulation for the treatment of essential tremor. Participants will be asked to remain seated with their head inside of a Magnetoencephalography (MEG) recording system as resting-state and task-related data are acquired. Spontaneous electrophysiological activity will be recorded in both the eyes open and eyes closed conditions with the participant seated comfortably. These recordings will be repeated in the DBS OFF and DBS ON states, with the ON state involving specific settings identified as optimal, sub-optimal, or ineffective at achieving tremor control. They will also be repeated following the optional administration non-DBS tremor mitigation techniques, which may include one or more of 1) cooling the limb, 2) oral administration of alprazolam, 3) oral consumption of ethanol (alcohol), or 4) peripheral nerve stimulation.

开始日期2024-03-25

申办/合作机构-

100 项与阿普唑仑相关的临床结果

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100 项与阿普唑仑相关的转化医学

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100 项与阿普唑仑相关的专利（医药）

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2,686

项与阿普唑仑相关的文献（医药）

2025-01-01·Progress in Neuro-Psychopharmacology and Biological Psychiatry

Mother's little helper turned a foe: Alprazolam use, misuse, and abuse

Review

作者: Meisser, Noelle ; Vardeleon, Nathan I ; Steiner, Heinz ; Cardona-Acosta, Astrid M ; Bolaños-Guzmán, Carlos A

Benzodiazepines are effective in managing anxiety and related disorders when used properly (short-term). Their inappropriate use, however, carries significant risks, involving amnesia, rebound insomnia, rebound anxiety, depression, dependence, abuse, addiction, and an intense and exceedingly prolonged withdrawal, among other complications. Benzodiazepines also amplify the effects of opioids and, consequently, have been implicated in approximately 30 % of opioid overdose deaths. Despite their unfavorable profile, sharp increases in medical and non-medical use of benzodiazepines have been steadily reported worldwide. Alprazolam (Xanax®), a potent, short-acting benzodiazepine, is among the most prescribed and abused anxiolytics in the United States. This medication is commonly co-abused with opioids, increasing the likelihood for oversedation, overdose, and death. Notwithstanding these risks, it is surprising that research investigating how benzodiazepines, such as alprazolam, interact with opioids is severely lacking in clinical and preclinical settings. This review therefore aims to present our current knowledge of benzodiazepine use and misuse, with an emphasis on alprazolam when data is available, and particularly in populations at higher risk for developing substance use disorders. Additionally, the potential mechanism(s) surrounding tolerance, dependence and abuse liability are discussed. Despite their popularity, our understanding of how benzodiazepines and opioids interact is less than adequate. Therefore, it is now more important than ever to understand the short- and long-term consequences of benzodiazepine/alprazolam use.

2024-12-01·Sleep Medicine: X

Case report on melatonin overdose: Cause and concern

Article

作者: Bano, Hina ; Tripathi, Richa ; Alam, Mohd Rashid

Melatonin, the primary hormone secreted by the pineal gland, regulates central and peripheral oscillators and adapts the internal environment to the external one through MT1 and MT2 receptors. The authors present a case of 16-year-old male intentionally overdosed on 900mg of melatonin (180 tablets) and 10 tablets of 0.5mg alprazolam. Admitted to the emergency department, he was extremely drowsy and minimally responsive with a Glasgow coma scale score of 8/15. Vital signs were stable, and no renal or liver dysfunction was noted. Elevated total leucocyte count and positive benzodiazepine urine test were observed. Gastric lavage was performed, and toxicology reports showed blood alprazolam levels at 0.15 mg/litre eight hours post-overdose. The patient regained consciousness 32 hours post-ingestion and was transferred to the psychiatry unit. This case underscores the increasing abuse of melatonin due to its easy availability and lack of regulation. Although melatonin has a low toxicity potential, side effects and interactions with other drugs can be severe. Supportive measures and vital sign control are crucial in overdose treatment.

2024-12-01·Journal of Psychopharmacology

Evaluation of the sedative-motor effects of novel GABAkine imidazodiazepines using quantitative observation techniques in rhesus monkeys

Article

作者: Berro, Laís F ; Mian, Md Yeunus ; Sharmin, Dishary ; Rüedi-Bettschen, Daniela ; Platt, Donna M ; Pareek, Tanya ; Golani, Lalit ; Rashid, Farjana ; Reeves-Darby, Jaren A ; Cook, Jemma E ; Rowlett, James K ; Cook, James M ; Moreira-Junior, Eliseu da Cruz

Background: Benzodiazepines bind to γ-aminobutyric acid type A (GABAA) receptor subtypes identified by different α subunits (i.e., α1GABAA, α2GABAA, α3GABAA, and α5GABAA). Sedative-motor effects of benzodiazepines are thought to involve α1GABAA and α3GABAA subtypes. Aims: We evaluated observable measures of sedative-motor effects and species-typical behaviors in monkeys following acute administration of novel GABAkines (positive allosteric modulators of GABAA receptors), with varying degrees of selective efficacy at different GABAA receptor subtypes. We predicted that the induction of sedative-motor effects would depend on the degree of α1GABAA and α3GABAA efficacy. Methods: Adult female rhesus monkeys ( N = 4) were implanted with chronic indwelling i.v. catheters. Quantitative behavioral observation was conducted by trained observers following administration of multiple doses of the conventional benzodiazepine alprazolam and the GABAkines MP-III-80 (preferential efficacy at α2/α3/α5GABAA subtypes), KRM-II-81, MP-III-24 (both with preferential efficacy for α2/α3GABAA subtypes), and MP-III-22 (preferential potency and efficacy for α5GABAA subtypes). Results: As with alprazolam, all GABAkines induced significant levels of mild sedation (“rest/sleep posture”). Deep sedation was observed with alprazolam, MP-III-80, and MP-III-22; motoric effects (observable ataxia) were obtained with alprazolam, KRM-II-81, and MP-III-22 only. Surprisingly, the order of potency for rest/sleep posture was significantly associated only with potency at α5GABAA subtypes. Conclusions: GABAkines with preferential efficacy at α2/α3GABAA and/or α5GABAA subtypes engendered sedative-motor effects in monkeys, although only compounds with α5GABAA activity engendered deep sedation. Moreover, the significant relationship between potency obtained with in vitro electrophysiology data and the rest/sleep posture measure suggests a role for the α5GABAA subtype in this milder form of sedation.

项与阿普唑仑相关的新闻（医药）

2024-11-10

·美柏医健

蓝海赛道开出王炸

三十余年来FDA未批准一款药物用于该适应症，MASH研发黑洞的称号并不是说说而已。但最近Madrigal第三季度的财报开始颠覆了众人在该适应症上的“思想钢印”：TGF-β受体激动剂在MASH上大获成功，并已经在商业化上开始超预期放量。而在随后的研发管线之中，TGF-β，FGF21以及GLP-1靶点之间将陷入极其激烈的竞争。近日，司美格鲁肽在MASH适应症的III期临床试验也得到了令投资者们满意的结果。研发黑洞适应症，将会在不远的未来进入神仙打架阶段。 01 为什么是研发黑洞 MASH，即非酒精性脂肪性肝炎，两个关键词，非酒精性指的是该病发病并不是由于过度饮酒导致的肝脏损伤，脂肪性肝炎指的是肝内脂肪沉积，在严重的情况造成了肝细胞损伤和炎症。对于炎症而言，往往机制和通路呈现网状，调控极其复杂，往往在一个靶点上进行“狙击”，就会牵一发而动全身，找对基础机制和精准定位靶点是极其重要的。该病的发病的主线逻辑，与肝内脂肪细胞死亡以及肝脏细胞纤维化密切相关。一般而言，中年人随着体重的增加，将会导致肝脏内脂肪细胞的集聚，而肝内脂肪细胞的死亡和功能异常一方面将会导致体内胰岛素代谢紊乱，血糖升高，另一方面将会使得HSC（肝脏星型细胞）发生激活，进而促进导致肝脏纤维化。而肝脏纤维化在此前被看做是不可逆的过程。（图片来源：Madrigal官网PPT）如果要进行药物研发，那么改善患者肝脏的脂质代谢，或许会成为该药物研发的底层逻辑。此前，诸多药企在该适应症上都做了非常多的努力，但都失败。下图为比较临床III期失败管线的典例。（图片来源：药融云）其中排名第一的药物是奥贝胆酸，根据药融云的统计，也是第一个进入临床III期阶段的MASH药物。该药是FXR激动剂，它可以增加胆汁酸流失抑制酶（如CYP7A1）的表达，从而减少体内胆汁酸的合成，从而起到改善脂质的作用。根据III临床试验（REGENERATE）的结果，接受Obeticholic acid（25mg，每日1次）治疗18个月时有22.4%的患者实现了纤维化程度至少改善1级且未出现NASH恶化，而安慰剂组达到该指标的患者为9.6%，10mg组没有显著差异。但最后走到了FDA投票表决的阶段，并未准许该药通过。因为该药临床终点使用的是替代终点。替代终点意味着没有直观程度上看到病人病况的改变，以肿瘤为例，替代终点并不是病人最后的PFS这类生存期，而是肿瘤体积降低程度的指标。此外，该药的不良反应在此前PBC适应症中就已经掀起了较大波澜，在PBC适应症中，该药的初始剂量为5mg，而在MASH中需要达到25mg才有较为明显的疗效。奥贝胆酸于2016年5月27日获得FDA加速审评用于治疗PBC。到2021年FDA打上黑框警告为止，FDA发现了25例严重肝损伤导致肝代谢失调或肝功能衰竭的肝硬化PBC患者（包括有或无肝硬化临床症状的患者）。许多患者在开始使用奥贝胆酸之前就有晚期肝硬化。五倍的剂量，对肝损伤是否会更高？基于对安全性的顾虑，FDA最后专家投票阶段，否决了奥贝胆酸用于MASH适应症。2023年6月，其原研方Intercept发布公告，停止在MASH领域所有投资。或许新的机制，能够解决MASH的问题。 02 Madrigal与resmetirom Madrigal成为了第一个吃螃蟹的人。resmetirom作为甲状腺激素受体β(THR-β)激动剂在MASH适应症获得成功，是真正意义上的在MASH上撕开了一道口。 THR顾名思义，是接受甲状腺激素的受体，分为α和β两种亚型，前者广泛表达，后者在肝脏细胞中高表达。肝脏中至少90%的THR为THR-β。众所周知，甲状腺激素与能量代谢密切相关，因此，通过激动相关受体，去提高脂肪代谢效率，从而达到扭转MASH疾病的效果，或许是个不错的选择。而THR-β激动剂承担已经被证实在人体中具有降低低密度脂蛋白（LDL）、甘油三酯（TG）和肝脏脂肪变性的活性。通过促进脂肪酸的分解和刺激线粒体的生物发生，来减少脂肪毒性和减少肝脏脂肪，达到最终改善肝功能的目的。（图片来源：公众号西西弗斯的阿普唑仑）机制的优越性需要临床效果来检验。resmetirom临床设计中所用的III期临床终点和奥贝胆酸相同，同样是替代性临床终点：MASH改善的评分和纤维化至少降低一个阶段的比例。分为80mg组，100mg组和安慰剂组，每个组人数为300-400人。临床结果对照上，80毫克resmetirom组25.9%的患者和100毫克resmetirom组29.9% 的患者达到MASH缓解且纤维化未恶化，而安慰剂组这一比例为9.7%。80毫克resmetirom 组24.2%的患者和100毫克resmetirom组25.9%的患者纤维化改善至少一个阶段，且 NAFLD 活动评分未恶化，而安慰剂组这一比例为14.2%。（图片来源：A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis）相对于安慰剂组而言，疗效是较为显著的，相对于奥贝胆酸而言，100mg组的疗效也有进一步的显著增益。在安全性上，随着剂量显著提高的不良反应是腹泻，安慰剂组为15.6%，而100mg组达到了33.4%，不呈现剂量依赖性的不良反应是恶心。此外，比较值得称赞的是严重不良反应方面，两个治疗组与安慰剂组相比均没有明显的差异。这或许是相对奥贝胆酸最值得称赞的质的进步所在。获批后，就是商业化了。商业化方面，爬坡趋势也较为陡峭。在销售方面，该药从Q2开始销售，Q2销售额1400余万美元，Q3销售额达到了6200多万，大超预期。从环比的趋势来看，Q4继续放量，该药首年的销售额就有希望达到1.5亿美元。根据Evercore ISI分析师估计，2030年Resmetirom全球销售额可能达到约26亿美元，峰值可能达到55亿美元。也正是随着Q3业绩的披露，Madrigal的市值迅猛膨胀，从四十多亿美元两天内飙升到七十余亿美元。国内也并不缺少同靶点的布局，诚益生物的ECC4703便是典例，目前正处于临床I期将要完成的状态。此外，海思科的同靶点新药HSK31679也已经进入临床。 03 GLP-1入局——神仙打架即将开始这个适应症被引发广泛关注，与GLP-1在该病上的适应症拓展是有很大关系的。近日诺很诺德宣布司美格鲁肽在MASH适应症的III期临床上做出了差异化成果，研发黑洞的天又亮了一大块，神仙打架的时代，也许已经并不遥远。由于MASH与胰岛素分泌有千丝万缕的关系，因此作为治疗糖尿病的GLP-1类药物在适应症上有着拓展的潜力，这是一开始探索的基础。MASH的一个重大特征是肝脏的胰岛素抵抗，即肝脏内组织对胰岛素的作用效能减弱，而肝脏是负责将糖和脂质相互转化的重要器官，如果中间作用被影响，那么将会形成一个恶性循环，如图所示，胰岛素抵抗与高血糖相互影响，高血糖将会使得胰岛β细胞障碍，从而导致高脂血症，从而到了MASH的阶段：脂肪异常沉积甚至导致血液的脂类毒性。由于MASH与胰岛素分泌有千丝万缕的关系，因此作为治疗糖尿病的GLP-1类药物在适应症上有着拓展的潜力，这是一开始探索的基础。MASH的一个重大特征是肝脏的胰岛素抵抗，即肝脏内组织对胰岛素的作用效能减弱，而肝脏是负责将糖和脂质相互转化的重要器官，如果中间作用被影响，那么将会形成一个恶性循环，如图所示，胰岛素抵抗与高血糖相互影响，高血糖将会使得胰岛β细胞障碍，从而导致高脂血症，从而到了MASH的阶段：脂肪异常沉积甚至导致血液的脂类毒性。（图片来源：From NASH to diabetes and from diabetes to NASH: Mechanisms and treatment options）而GLP-1在介入血糖调节中，也就间接介入了肝脏的代谢中。根据早期研究的推测，GLP-1激动剂可以通过GLP-1 信号传导直接改善肝脏糖脂代谢并减少脂肪变性，但该推测目前缺乏更加有利的证据支撑。从目前该综述《From NASH to diabetes and from diabetes to NASH: Mechanisms and treatment options》，调节是一种网状的状态，很难确认机制之间的因果关系，只能通过相关药物，例如利拉鲁肽的动物模型去推测该药对于MASH是具有效果的。甚至目前来说，很难将体重减轻和MASH症状改善去分开解释，二者也许存在一定的因果关系，尤其在脂肪的减少上。机制后是临床数据。根据司美格鲁肽III期临床——ESSENCE的试验结果，每周2.4mg剂量的司美格鲁肽（Wegovy版本，减重同版本）的效果是有显著效果的。第72周，37.0%的司美格鲁肽2.4 mg治疗组患者肝纤维化改善且无脂肪性肝炎恶化，而安慰剂组这一比例为22.5%。62.9 %的索马鲁肽2.4 mg治疗组患者脂肪性肝炎缓解3且肝纤维化无恶化，而安慰剂组这一比例为34.1%。当然，这还只是第一阶段的顶线数据，该试验是个长期试验，后续还有持续的疗效观察时间。司美格鲁肽的成功是一个重要的里程碑，它的成功，是未来诸多GLP-1同款药物都可以复刻的，那对于这个市场，是一个很恐怖的药物倾注。 GLP-1之外，FGF21（成纤维细胞生长因子21）靶点的药物也在发力。它也是个代谢类疾病的新兴靶点，主要由肝脏组织产生，在胰腺β细胞、下丘脑和肌肉组织中表达，特异性作用于肝脏、脂肪、胰岛细胞，并且不依赖于胰岛素来调节血糖、血脂，可以说是一条较为新颖的通路。目前该靶点的典型药物是efruxifermin，一款安进开发的多肽分子，已经进入临床III期阶段。从该药来看，目前主要的想象力在于和GLP-1受体激动剂联用，就像它的IIb期临床一样。efruxifermin 50 mg组中24周时NASH缓解且肝纤维化未进展的患者比例高达76%，24周时肝纤维化逆转≥1期且NASH缓解的患者比例达到41%，这样的数据是比上文的THR-β激动剂非头对头比较更加显著的。二者联用，横扫MASH市场的未来，将不再遥远。结语 MASH是研发界三十年的黑洞，但根据近期看到的研发结果，resmetirom后面的GLP-1将以极为惊人的品类来横扫市场，并且与FGF21联用例如efruxifermin的效果极其显著，未来这个市场变成神仙打架，是完全可以预期的。

临床3期财报临床失败优先审批

2024-10-18

·PRNewswire

Introducing Clear Behavioral Health's 15th Location for Addiction Recovery and Mental Health Treatment

Gardena's Premier Destination for Residential, In-Network Treatment GARDENA, Calif., Oct. 17, 2024 /PRNewswire/ -- The vibrant city of Gardena has welcomed an exciting addition to its wellness community with the grand opening of Clear Behavioral Health Residential Rehab Treatment Center. As Clear's 15th location within Los Angeles County, this comprehensive behavioral health facility will serve Gardena, the South Bay, and surrounding areas by providing a residential rehab and detox facility for addiction recovery and dual diagnosis treatment. Continue Reading Step inside Clear Behavioral Health's Residential Rehab Treatment Center in Gardena, CA. Serving Los Angeles County and surrounding areas by providing a residential rehab and detox facility for addiction recovery and dual diagnosis treatment. At this new 20 bed facility, clinicians treat a wide variety of substance use disorders and mental health conditions, including Alcohol/Opiate/Stimulant Use Disorder, Benzodiazepine dependence, dual diagnosis addiction w/ depression, anxiety, trauma, ADHD Staggering statistics forecast that only 28% of eligible Detox/Rehab/RTC individuals, and a mere 11% of eligible PHP/IOP individuals, will receive treatment in 2026. Clear's new facility aims to bridge that gap for those in need of care. The new location expands Clear's treatment capacity by 20 beds, enabling more individuals to receive comprehensive, evidence-based treatment that most major insurance providers cover. At this new Gardena facility, clinicians treat a wide variety of substance use disorders and mental health conditions, including Alcohol Use Disorder, Opiate Use Disorder (heroin, fentanyl, kratom, pain killers), Stimulant Use Disorder (methamphetamine, Adderall, crack/cocaine), Benzodiazepine dependence (Xanax, Klonopin), dual diagnosis disorders including addiction with depression, anxiety, trauma, ADHD, and other mental health diagnoses. Our highly individualized treatment plans are tailored to meet each client's needs at every step of their recovery journey. Dr. Martha B. Koo, MD, Chief Medical Officer and Clinical Supervisor of Clear Behavioral Health, brings unparalleled expertise and passion to addressing mental health solutions through Clear's services. Dr. Koo obtained her psychiatry residency training at the Resnick Neuropsychiatric Institute at UCLA and her subsequent psychoanalytic training at the New Center for Psychoanalysis. She is double Board-Certified in Psychiatry and Addiction Medicine and has over twenty years of psychiatric experience. "Our services at Clear Behavioral Health are designed to be highly individualized, evidence-based, and holistic, ensuring that each client receives care tailored to their unique needs," said Dr. Martha Koo. "We believe in treating the whole person—addressing not just the symptoms of mental health and addiction disorders but also the underlying issues. Our compassionate and experienced staff create a warm, welcoming environment that fosters healing and recovery, empowering individuals to reclaim their lives." Joining Dr. Koo's team as the Clinical Director of Clear's Substance Use Disorder Division is Jason Bernstein, LMFT. Jason holds a master's degree in clinical psychology from Antioch University. With over five years of experience in the substance use and mental health field, he is passionate about supporting individuals seeking dual diagnosis treatment on their journey toward healing, growth, and achieving emotional and psychological wellbeing. His commitment to providing compassionate care and fostering an environment conducive to recovery positions him as a valuable leader for the Gardena facility. "Our inpatient rehab provides the safety and comfort needed for individuals to detox and rehabilitate from addiction while also addressing underlying mental health disorders," said Jason Bernstein. "We are excited to welcome our first clients to Gardena, where we're proud to provide whole-person family-centered care. Every person deserves the opportunity to recover, grow, and live a functional, happy life." The Gardena facility features a home-like, safe, and clinical environment. Program Director Jamie Arthur, CATC, CADC-II, has over 10 years of experience in the substance use recovery field and is dedicated to ensuring clients receive a robust range of program services to launch their recovery. Services include: Round-the-Clock Clinical Staff: Our compassionate team led by Jason Giles, MD, and Brittany Skinner, PMHNP provides 24/7 supervised care. Peer Support: Group therapy sessions foster a sense of unity while providing the space to develop healthy relationships. Medication Management: Safe transitions into detox help patients regain mental and physical stability as comfortably as possible. Therapy and Counseling: Individual therapy and counseling help patients uncover the root of their mental health struggles and develop tools to regain self-trust and balance. Experiential Therapies: Group therapeutic wellness activities such as yoga, meditation and sound healing enhance recovery. In addition to the Gardena launch, Clear Behavioral Health has recently opened facilities in Van Nuys and El Segundo, providing outpatient mental health treatments for adults and teens. These locations offer Intensive Outpatient Programs (IOP), including individual therapy, peer support, holistic therapies, and academic counseling. Founded in 2015, Clear Behavioral Health is a subsidiary of Your Behavioral Health, a leading regional provider of mental health and addiction treatment services for adults and teens, with 28 facilities and growing throughout Southern California. Your Behavioral Health provides the full continuum of behavioral health care, including detox, outpatient (PHP/IOP), interventional psychiatry, and residential care across its family of brands — which includes Clear Behavioral Health, New Life House, and Neuro Wellness Spa — and delivers specialized programs for depression, anxiety, trauma-related issues, addiction and other mental health conditions. Co-founders Mike Joly, Chief Executive Officer, and Dr. Martha Koo, Chief Medical Officer, lead Your Behavioral Health alongside an expert team of clinicians across Southern California. For more information about Clear Behavioral Health or to schedule a free consultation, please visit our website at or call us at 877-564-5571. About Clear Behavioral Health ClClear Behavioral Health, formerly Clear Recovery Center, is a leading Los Angeles-based provider of comprehensive, in-network behavioral health treatment programs. Our mission is simple: to help those struggling with mental health and addiction live healthy and purposeful lives. Our unique story started with a vision to make clinically excellent, highly individualized mental health services accessible to all. For a list of our 15 locations, visit . About Your Behavioral Health Your Behavioral Health is a leading regional behavioral health services platform providing comprehensive, best-in-class services for adults and teens across the continuum of mental health and addiction treatment. With state-of-the-art facilities across Southern California, expert clinical teams, and a pioneering evidence-based approach, Your Behavioral Health offers specialized residential, inpatient, and outpatient programs for a range of mental health conditions. Its family of brands includes Clear Behavioral Health, New Life House, and Neuro Wellness Spa. For more information, please visit . Contact: Stephanie Paz Townsend (310) 295-0429 [email protected] SOURCE Clear Behavioral Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-10-11

·复星医药

复星医药：药友两产品同日获批上市

2024年10月8日，国家药品监督管理局官网显示，药友集团两产品获批上市并视同通过仿制药质量和疗效一致性评价，分别为：药友制药的普伐他汀钠片（10mg）、湖南洞庭药业的马来酸氟伏沙明片（50mg）。 01/普伐他汀钠片 1989年在日本首次获批上市，用于高脂血症、家族性高胆固醇血症。普伐他汀为3-羟基-3-甲基戊二酰辅酶 A（HMG-CoA）还原酶抑制剂。选择性地作用于合成胆固醇的主要脏器肝脏和小肠，迅速且强力降低血清胆固醇值，改善血清脂质。其通过二方面发挥降脂作用。第一为可逆性抑制 HMG-CoA还原酶活性使细胞内胆固醇的量有一定程度的降低，导致细胞表面的低密度脂蛋白（LDL）受体数的增加，从而加强了由受体介导的低密度脂蛋白胆固醇（LDL-C）的分解代谢和血液中 LDL-C的清除。第二，通过抑制 LDL-C的前体——极低密度脂蛋白胆固醇（VLDL-C）在肝脏中的合成从而抑制 LDL-C 的生成。他汀类药物能显著降低血清总胆固醇（TG）、LDL⁃C和载脂蛋白B（ApoB）水平，适用于高胆固醇血症、混合型高脂血症和动脉粥样硬化性心血管疾病（ASCVD）的防治。普伐他汀是唯一不依赖细胞色素P450酶系统代谢的他汀，发生药物相互作用概率较低。此外，普伐他汀发生肝功能异常、肌肉痛、血糖升高等不良反应的风险亦更低。他汀类药物是降脂药物的基石，被国内外多指南推荐用于血脂管理与心血管事件预防：《中国血脂管理指南（2023年）》：中等强度的他汀类药物是中国人群降脂治疗的首选策略。普伐他汀40mg剂量属于中等强度。《中国心血管病一级预防指南（2020年）》：他汀类药物用于ASCVD一级预防证据最为充分。大量研究证实他汀类药物可显著降低高、中甚至低危人群的ASCVD风险。《美国预防临床服务指南工作组推荐声明（2022年）》：推荐40~75岁伴有≥1种CVD危险因素（血脂异常、糖尿病、高血压、吸烟）且10年CVD风险≥10%的成年人使用他汀类药物进行CVD的一级预防。 1995年，普伐他汀钠片在我国获批用于高脂血症、家族性高胆固醇血症。我国已上市片剂和胶囊剂，均为国家医保乙类品种。目前，我国普伐他汀市场规模已超6.6亿元，市场容量连续增长，现已超3.8亿片（以10mg计）。数据来源：IQVIA，RPDB 截至发稿，普伐他汀钠片已有5家企业通过或视同通过一致性评价，尚有4家企业正在审评审批中，暂未纳入国家带量采购。通过/视同通过一致性评价的企业普伐他汀钠片是药友制药首个视同过评的降脂药物，进一步丰富了药友制药在三高（高血脂、高血压、高血糖）领域的产品集群。 02/马来酸氟伏沙明片 1983年在瑞士首次获批上市，用于抑郁症、强迫症。氟伏沙明为选择性5-羟色胺再摄取抑制剂（SSRIs），是全球第一款SSRIs类药物，主要通过选择性抑制中枢神经突触前膜对5-羟色胺（5-HT）的再摄取，同时使5-HT受体脱敏，特别是5-HT1A受体，增强5-HT传递，增加突触间隙5-HT的有效浓度而发挥药理作用；同时亦可通过CYP1A2影响褪黑素在肝脏的代谢，提高血清褪黑素浓度，改善睡眠和生物节律，是唯一直接影响褪黑素浓度的SSRIs；氟伏沙明还具有激动σ-1受体调节谷氨酸释放，修复神经和改善认知功能，进一步增强其抗抑郁作用。指南推荐：《中国抑郁障碍防治指南（第二版）》推荐氟伏沙明等SSRIs类药物作为一线抗抑郁药物。《中国强迫症防治指南（2016年）》推荐氟伏沙明为强迫症一线治疗药物。《焦虑障碍防治指南（2010年）》推荐氟伏沙明作为焦虑障碍的一线推荐用药。《创伤后应激障碍防治指南》中指出，氟伏沙明是治疗PTSD的常用药物。马来酸氟伏沙明片为国家医保乙类品种，根据IQVIA CHPA数据，其医院市场规模5.9亿元，5年复合增长率25.7%，市场容量2.5亿片（以50mg计），近年连续保持快速增长。数据来源：IQVIA 截至发稿，已有9家企业通过或视同通过一致性评价，尚有14家企业正在审评审批中，暂未纳入国家带量采购。通过/视同通过一致性评价的企业 CNS领域是药友核心领域之一，仅2024年已有7个产品获批，截至目前，CNS领域共20个品种34个品规通过/视同通过一致性评价，多个品种为首家/独家。相关链接药友制药药友制药成立于1939年中华民族危难时刻，10余名爱国大学师生以“谋医药之永远自给，药学之逐日昌明，分担建国复兴工作”的创始宗旨，创立了药友制药。经过80余年的发展，药友制药已成为一家拥有完整医药产业链的集团化、国家级重点高新技术企业。公司自主研发生产的原料药及制剂产品已先后在欧美市场上市，重点冻干产品荣获“国家科技进步二等奖”。药友制药成员企业湖南洞庭药业洞庭药业是药友制药旗下成员企业，创建于1958年，位于湖南常德，是国内精神科药物和化学止血药领域的领先企业。经过多年的技术革新和市场竞争，止血药和精神科药成为洞庭药业的主导产品。止血药氨甲环酸、氨甲苯酸形成了产销规模大、质量好的超前优势；精神科药走上了品种、规格、剂型齐步发展的快车道，主要类别有抗精神分裂症药、抗抑郁药、抗癜痫药、镇静催眠药。洞庭药业是湖南省级企业技术中心，省精神药物工程技术研究中心、拥有省著名商标、省国际知名品牌等荣誉称号以及“止血环酸的生产方法”、“制备药物纯富马酸喹硫平的生产方法”、“富马酸喹硫平缓控释制剂组合物及其应用”等多项国家发明专利和外观专利。洞庭药业建立了可靠的产品质量保障体系，全部产品取得了国家GMP认证证书。氨甲环酸质量符合美国药典、英国药典、日本药局方和欧洲药典标准，并通过了美国FDA、英国MHRA、欧盟COS、日本PMDA认证，出口到30多个国家和地区，拥有劳拉西泮片、阿普唑仑片、氯硝西泮片等精神二类管制药品生产资质。

上市批准一致性评价

100 项与阿普唑仑相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00225	阿普唑仑	N05BA12	DB00404

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
紧张症	日本	Teva Takeda Pharma Ltd.初创企业	1984-02-15
抑郁症	日本	Teva Takeda Pharma Ltd.初创企业	1984-02-15
抑郁症	日本	VIATRIS Pharmaceuticals Ltd.	1984-02-15
入睡和睡眠障碍	日本	Teva Takeda Pharma Ltd.初创企业	1984-02-15
入睡和睡眠障碍	日本	VIATRIS Pharmaceuticals Ltd.	1984-02-15
焦虑症	美国	Upjohn US 2 LLC	1981-10-16
惊恐障碍	中国	-	-

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
癫痫持续状态	临床3期	美国	UCB Biopharma SRL	2021-12-07
癫痫持续状态	临床3期	澳大利亚	UCB Biopharma SRL	2021-12-07
癫痫持续状态	临床3期	意大利	UCB Biopharma SRL	2021-12-07
癫痫持续状态	临床3期	捷克	UCB Biopharma SRL	2021-12-07
癫痫持续状态	临床3期	法国	UCB Biopharma SRL	2021-12-07
癫痫	临床3期	-	UCB SA	-
焦虑症	临床2期	美国	UCB, Inc.	2005-01-19
惊恐障碍	临床2期	美国	UCB, Inc.	2005-01-19

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临床结果

适应症

分期

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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


NCT04782388 (UP0101, AAN2024)	临床1期	-	-	Staccato Alprazolam 2 mg	(鏇壓築淵艱膚醖製艱積) = AUC0-t showed a similar trend to AUCinf 選觸鹹憲齋網繭蓋製鏇 (窪鬱衊網獵製鹽淵醖簾 ) 更多	积极	2024-04-09
				Staccato Placebo
NCT04970342 (PDID, CTgov)	临床1期	-	13	Placebo (Lactose) Capsule+Cannabis (0%/ THC / 0% CBD) ("Sober" or Double Placebo)	艱繭顧鬱糧範襯鹹夢願(積衊壓廠遞夢選繭憲積) = 鹽衊艱夢選繭齋鬱製蓋願齋衊艱廠憲鏇鏇廠獵 (窪簾顧積構願鏇憲鬱獵, 廠繭願簾廠膚蓋鏇簾選 ~ 鏇廠齋範夢網製選醖願) 更多	-	2023-07-25
				Cannabis (0%/ THC / 0% CBD)+0.75 mg Alprazolam Capsule (Active Alprazolam (Xanax), Placebo Cannabis)	艱繭顧鬱糧範襯鹹夢願(積衊壓廠遞夢選繭憲積) = 淵範窪鏇窪積獵壓鬱憲願齋衊艱廠憲鏇鏇廠獵 (窪簾顧積構願鏇憲鬱獵, 廠衊製顧襯膚鏇築積鹽 ~ 齋淵鹹鏇廠觸觸構築壓) 更多
NCT03478982 (ENGAGE-E-001, Pubmed)	临床2期	癫痫	116	Staccato® alprazolam 1.0 mg	憲齋淵壓廠築網艱餘糧(遞顧夢廠壓顧夢繭膚觸) = 夢構鬱繭製襯襯觸憲範鬱遞網膚襯製鹽鬱鏇齋 (憲獵醖觸製範願壓選遞 )	-	2022-10-21
				Staccato® alprazolam 2.0 mg	憲齋淵壓廠築網艱餘糧(遞顧夢廠壓顧夢繭膚觸) = 鏇廠鏇鑰鑰鏇觸製製繭鬱遞網膚襯製鹽鬱鏇齋 (憲獵醖觸製範願壓選遞 )
NCT03478982 (P1.5-023, AAN2019)	临床2期	癫痫	8	Staccato Alprazolam 1 mg	(窪繭蓋構廠鑰鑰範餘積) = no adverse events were serious or severe 網餘網網鏇襯齋鏇鏇壓 (憲網遞鏇鹽鬱顧窪鏇鏇 )	积极	2019-04-09
NCT03447353 (CTgov)	临床4期	-	18	Placebo Oral Tablet ("Sober" or Double Placebo)	遞窪鹽憲願夢壓壓鬱遞(膚網築遞醖窪願壓網獵) = 鬱網鑰築築積網獵艱窪築夢築構鹹鑰糧積簾顧 (鹹網簾夢網簾壓積廠襯, 鹹顧鏇餘獵鹹鹹憲夢鹽 ~ 獵製襯憲網壓簾簾選淵) 更多	-	2018-09-27
				Norco 10Mg-325Mg Tablet+Xanax 1Mg Tablet (Active Xanax, Active Norco)	遞窪鹽憲願夢壓壓鬱遞(膚網築遞醖窪願壓網獵) = 網餘顧遞醖鑰顧構獵糧築夢築構鹹鑰糧積簾顧 (鹹網簾夢網簾壓積廠襯, 製積壓簾鹽衊網鹽遞襯 ~ 構鑰衊鏇鬱鑰鏇鹹觸襯) 更多
NCT00477451 (CTgov)	临床2期	恐慌 \| 惊恐障碍	49	Inhaled placebo+IV doxapram (RCT Placebo)	衊繭窪鹹築糧餘膚鹽簾(窪廠繭鑰網餘築齋廠餘) = 憲鏇餘蓋積製蓋襯衊構範廠夢鹽艱鏇築窪窪製 (積廠餘鹽鬱膚築餘鑰鏇, 網膚艱壓衊築鏇窪膚顧 ~ 鹹蓋夢構製範襯構襯壓) 更多	-	2017-06-16
				IV doxapram+Inhaled alprazolam 1 mg (RCT Alprazolam 1 mg)	衊繭窪鹹築糧餘膚鹽簾(窪廠繭鑰網餘築齋廠餘) = 壓蓋壓觸襯築積淵鏇壓範廠夢鹽艱鏇築窪窪製 (積廠餘鹽鬱膚築餘鑰鏇, 壓鏇餘艱襯繭鏇壓製製 ~ 簾鹽衊積淵簾築簾糧鹽) 更多
NCT01577706 (CEBRA2, CTgov)	N/A	物质滥用	7	Placebo (Placebo)	鹽壓繭構夢窪觸鬱憲衊(鏇網廠夢夢艱醖窪壓觸) = 鹽願獵網憲襯齋淵構憲餘糧顧襯醖鑰繭遞鬱製 (膚範繭願鬱獵艱鹽選網, 鹹鹽艱範願觸築鏇構鹹 ~ 襯糧憲糧糧顧繭鬱獵糧) 更多	-	2017-04-04
				Alprazolam (Alprazolam)	鹽壓繭構夢窪觸鬱憲衊(鏇網廠夢夢艱醖窪壓觸) = 鏇鬱製鬱襯獵醖餘衊醖餘糧顧襯醖鑰繭遞鬱製 (膚範繭願鬱獵艱鹽選網, 糧齋顧鏇糧簾顧築淵蓋 ~ 壓鑰鑰顧夢範觸夢範範) 更多
NCT00603980 (Pubmed \| Psychopharmacology (Berl))	临床1期	药物滥用	14	Inhaled alprazolam	範簾醖壓積顧襯範壓鏇(艱蓋獵選願蓋餘蓋觸築) = 鹹築願憲淵選築簾廠蓋淵鏇壓餘選選夢壓廠憲 (糧簾願鏇鬱艱構艱簾壓 )	-	2015-03-01
				Oral alprazolam	範簾醖壓積顧襯範壓鏇(艱蓋獵選願蓋餘蓋觸築) = 艱遞襯衊築鹹糧餘獵艱淵鏇壓餘選選夢壓廠憲 (糧簾願鏇鬱艱構艱簾壓 )
NCT00356278 (CTgov)	临床2/3期	创伤后应激障碍	156	D-cycloserine (VRE Therapy and D-cycloserine)	遞衊憲夢窪膚膚廠窪積(製鹹憲選醖糧觸膚構願) = 製廠憲襯糧膚觸遞願築鑰蓋積艱夢膚襯繭鏇糧 (鹽網範淵膚憲蓋夢鹹鑰, 醖簾獵獵壓製範夢淵觸 ~ 淵簾繭顧鏇範襯壓膚鏇) 更多	-	2014-11-19
				Alprazolam (VRE Therapy and Alprazolam)	遞衊憲夢窪膚膚廠窪積(製鹹憲選醖糧觸膚構願) = 壓獵衊範鑰鹹衊簾鑰鬱鑰蓋積艱夢膚襯繭鏇糧 (鹽網範淵膚憲蓋夢鹹鑰, 齋襯齋鹹觸鹹製網餘壓 ~ 簾齋選淵鹽膚網壓觸簾) 更多
NCT01949038 (Pubmed \| Endoscopy)	临床2/3期	-	220	Sublingual alprazolam	廠範蓋鹽衊鏇願襯糧觸(獵艱艱膚鑰簾選艱簾鹽) = 網築餘遞獵願遞艱襯構襯製選醖顧衊膚鬱築繭 (窪餘窪餘製觸選壓築艱 )	积极	2014-08-01
				Oral alprazolam	廠範蓋鹽衊鏇願襯糧觸(獵艱艱膚鑰簾選艱簾鹽) = 築艱築淵網衊繭顧網獵襯製選醖顧衊膚鬱築繭 (窪餘窪餘製觸選壓築艱 )