更新于：2024-12-18

Methylphenidate Hydrochloride

盐酸哌甲酯

更新于：2024-12-18

概要

概要

基本信息

简介盐酸哌醋甲酯是一种中枢神经系统兴奋剂，于1955年12月5日在美国首次获批上市，由诺华制药公司生产。该药物主要用于治疗嗜睡症、注意力缺陷障碍和多动症等疾病。其化学名称为甲基α-苯基-2-哌嗪乙酸酯盐酸盐，可刺激中枢神经系统，提高警觉性和注意力，从而改善症状。盐酸哌醋甲酯已被广泛应用于治疗注意力缺陷障碍和多动症等儿童和青少年常见的神经行为疾病，是一种较为安全和有效的治疗药物。

药物类型

小分子化药

别名

D-MPH、Methyl phenidylacetate、methyl phenyl(piperidin-2-yl)acetate

+ [36]

靶点

DAT

作用机制

多巴胺重摄取抑制剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

MEDICE Arzneimittel Pütter GmbH & Co. KG

苏州第壹制药有限公司

+ [16]

非在研机构

Novartis Pharmaceuticals Corp.

ALZA Corp.

Purdue Pharma LP

+ [6]

最高研发阶段批准上市

首次获批日期

美国 (1955-12-05),

注意缺陷障碍发作性睡病

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C14H20ClNO2

InChIKeyJUMYIBMBTDDLNG-UHFFFAOYSA-N

CAS号298-59-9

关联

509

项与盐酸哌甲酯相关的临床试验

CTIS2023-506202-40-01 / RecruitingIIT

Effectiveness of methylphenidate in children and adolescents with KBG syndrome: An N-of-1 series - 113883

开始日期2024-11-13

申办/合作机构-

NCT06580041 / Enrolling by invitation临床4期IIT

Precision Care for Major Depressive Disorder

This study aims to assess whether phenotyping-guided intervention selection is superior to intervention selection without phenotyping guidance (i.e., routine clinician and patient judgment regarding treatment selection) for depression.

开始日期2024-11-12

申办/合作机构

The University of California, San Francisco

NCT06431256 / Recruiting临床3期

Phase 3, Multicenter, 3-Week Fixed-dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy, Safety and Pharmacokinetic Study of Evening Dosed Methylphenidate Hydrochloride Extended-Release Capsules (HLD200) in Children Aged 4 to 5 Years With ADHD

This study will evaluate the efficacy, safety and pharmacokinetics of HLD200 (20 mg and 40 mg) in children aged 4 to 5 years with ADHD.

开始日期2024-09-13

申办/合作机构

Ironshore Pharmaceutical & Development, Inc.

[+1]

100 项与盐酸哌甲酯相关的临床结果

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100 项与盐酸哌甲酯相关的转化医学

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100 项与盐酸哌甲酯相关的专利（医药）

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8,497

项与盐酸哌甲酯相关的文献（医药）

2025-01-01·NeuroImage-Clinical

Prediction of methylphenidate treatment response for ADHD using conventional and radiomics T1 and DTI features: Secondary analysis of a randomized clinical trial

Article

作者: van der Pal, Zarah ; Caan, Matthan W A ; Reneman, Liesbeth ; Kooij, Sandra J J ; Poirot, Maarten G ; Bottelier, Marco ; Chen, Mingshi ; Marquering, Henk A ; Schrantee, Anouk

BACKGROUND:

Attention-Deficit/Hyperactivity Disorder (ADHD) is commonly treated with methylphenidate (MPH). Although highly effective, MPH treatment still has a relatively high non-response rate of around 30%, highlighting the need for a better understanding of treatment response. Radiomics of T1-weighted images and Diffusion Tensor Imaging (DTI) combined with machine learning approaches could offer a novel method for assessing MPH treatment response.

PURPOSE:

To evaluate the accuracy of both conventional and radiomics approaches in predicting treatment response based on baseline T1 and DTI data in stimulant-naive ADHD participants.

METHODS:

We performed a secondary analysis of a randomized clinical trial (ePOD-MPH), involving 47 stimulant-naive ADHD participants (23 boys aged 11.4 ± 0.4 years, 24 men aged 28.1 ± 4.3 years) who underwent 16 weeks of treatment with MPH. Baseline T1-weighted and DTI MRI scans were acquired. Treatment response was assessed at 8 weeks (during treatment) and one week after cessation of 16-week treatment (post-treatment) using the Clinical Global Impressions - Improvement scale as our primary outcome. We compared prediction accuracy using a conventional model and a radiomics model. The conventional approach included the volume of bilateral caudate, putamen, pallidum, accumbens, and hippocampus, and for DTI the mean fractional anisotropy (FA) of the entire brain white matter, bilateral Anterior Thalamic Radiation (ATR), and the splenium of the corpus callosum, totaling 14 regional features. For the radiomics approach, 380 features (shape-based and first-order statistics) were extracted from these 14 regions. XGBoost models with nested cross-validation were used and constructed for the total cohort (n = 47), as well as children (n = 23) and adults (n = 24) separately. Exact binomial tests were employed to compare model performance.

RESULTS:

For the conventional model, balanced accuracy (bAcc) in predicting treatment response during treatment was 63 % for the total cohort, 32 % for children, and 36 % for adults (Area Under the Receiver Operating Characteristic Curve (AUC-ROC): 0.69, 0.33, 0.41 respectively). Radiomics models demonstrated bAcc's of 68 %, 64 %, and 64 % during treatment (AUC-ROCs of 0.73, 0.62, 0.69 respectively). These predictions were better than chance for both conventional and radiomics models in the total cohort (p = 0.04, p = 0.003 respectively). The radiomics models outperformed the conventional models during treatment in children only (p = 0.02). At post-treatment, performance was markedly reduced.

CONCLUSION:

While conventional and radiomics models performed equally well in predicting clinical improvement across children and adults during treatment, radiomics features offered enhanced structural information beyond conventional region-based volume and FA averages in children. Prediction of symptom improvement one week after treatment cessation was poor, potentially due to the transient effects of stimulant treatment on symptom improvement.

2025-01-01·WATER RESEARCH

Pharmaceuticals in urban streams: A review of their detection and effects in the ecosystem

Review

作者: Silva, Liliana J G ; Rodrigues, Fernanda ; João Feio, Maria ; Simões, Nuno E.C. ; Silva, Liliana J.G. ; Pereira, André M. P.T. ; Simões, Nuno E C ; Durães, Luisa ; Pereira, André M.P.T. ; Pereira, André M P T

The presence of pharmaceuticals in urban freshwater has been considered an emerging issue. Although rivers are better studied, the streams crossing the cities, which are prone to higher concentrations of pharmaceuticals, and with a higher potential to affect animals, plant and human health, were never specifically addressed in a review. Thus, here we performed a literature review on the existing pharmaceutical contamination and impacts of these compounds in the urban stream ecosystems. To structure the review, 10 questions were designed. From a total of 206 scientific publications, only 51 addressed the issue of pharmaceuticals in urban streams compared to 180 studies in the larger urban rivers. In 49 urban streams located in 13 countries and four continents, 139 pharmaceuticals from ten therapeutic groups were found. Anti-inflammatories and anticonvulsants were detected in the largest number of countries and urban streams, but the latter was more frequent in the streams. Metabolites were also detected, sometimes in higher concentrations than the original pharmaceutical but they were seldom analysed. The pharmaceuticals that caused more effects in the aquatic organisms were 17β-estradiol, estriol, estrone, acetaminophen, caffeine, carbamazepine, diltiazem, diphenhydramine, fluoxetine, norfluoxetine, sertraline, desmethylsertraline, methylphenidate and ciprofloxacin. The effects were varied, from bioaccumulation, endocrine disruption, impaired growth, reproduction inhibition, increased mortality and hatching disorder to morphological alterations, and decreased gross primary production and biomass. Streams had a higher mixture risk compared to the rivers. Important knowledge gaps detected are the low frequency of analysis of metabolites, the inefficient treatment of urban sewage regarding pharmaceuticals and the reduced number of studies on the impacts of pharmaceuticals at the aquatic community/population and functional level.

2024-12-01·EUROPEAN JOURNAL OF NEUROLOGY

Pharmacotherapy for behavioural manifestations in frontotemporal dementia: An expert consensus from the European Reference Network for Rare Neurological Diseases (ERN‐RND)

Article

作者: Vandenberghe, Rik ; Saracino, Dario ; Djamshidian, Atbin ; Capellari, Sabina ; Boban, Marina ; De Winter, François‐Laurent ; Rohrer, Jonathan ; Wittebrood, Casper ; Rodriguez, Eloy Rodriguez ; Cagnin, Annchiara ; González, Manuel Menéndez ; Levin, Johannes ; Reetz, Kathrin ; Graessner, Holm ; Rusina, Robert ; Krajcovicova, Lenka ; Reinhard, Carola ; Seelar, Harro ; Krüger, Johanna ; Van Langenhove, Tim ; Houot, Marion ; Hjermind, Lena E.

Abstract:

Background and Purpose:

Frontotemporal dementia (FTD) is a neurodegenerative disorder characterized by pervasive personality and behavioural disturbances with severe impact on patients and caregivers. In current clinical practice, treatment is based on nonpharmacological and pharmacological approaches. Unfortunately, trial‐based evidence supporting symptomatic pharmacological treatment for the behavioural disturbances in FTD is scarce despite the significant burden this poses on the patients and caregivers.

Method:

The study examined drug management decisions for several behavioural disturbances in patients with FTD by 21 experts across European expert centres affiliated with the European Reference Network for Rare Neurological Diseases (ERN‐RND).

Results:

The study revealed the highest consensus on drug treatments for physical and verbal aggression, impulsivity and obsessive delusions. Antipsychotics (primarily quetiapine) were recommended for behaviours posing safety risks to both patients and caregivers (aggression, self‐injury and self‐harm) and nightly unrest. Selective serotonin reuptake inhibitors were recommended for perseverative somatic complaints, rigidity of thought, hyperphagia, loss of empathy and for impulsivity. Trazodone was specifically recommended for motor unrest, mirtazapine for nightly unrest, and bupropion and methylphenidate for apathy. Additionally, bupropion was strongly advised against in 10 out of the 14 behavioural symptoms, emphasizing a clear recommendation against its use in the majority of cases.

Conclusions:

The survey data can provide expert guidance that is helpful for healthcare professionals involved in the treatment of behavioural symptoms. Additionally, they offer insights that may inform prioritization and design of therapeutic studies, particularly for existing drugs targeting behavioural disturbances in FTD.

198

项与盐酸哌甲酯相关的新闻（医药）

2024-11-20

·药事纵横

FDA专家案例分享：讲解仿制缓释制剂设计中的注意事项

本文案例节选自Pharmaceutical Equivalence by Design for Generic Drugs: Modified-Release Products一文，这3个案例表明了在仿制缓释制剂设计中的注意事项，值得思考。作者：André Sirota Raw & Robert Lionberger & Lawrence X. Yu 摘要：美国CDER仿制药办公室（OGD）为确保仿制药的高质量提出了两项要求，仿制药需与参比制剂（RLD）药学等效和生物等效。这两项要求成功使得仿制药和参比制剂具有相同的治疗效果。然而随着制剂被设计的日益复杂，仿制药一致性评价的方法也应该与时俱进。质量源于设计（QBD）通过引入目标产品质量概况（QTPP）的概念提供了一个很好的方法。这篇文章通过3个例子介绍QBD方法在当前评价缓控释制剂提高生物等效性方面的作用，采用使用适当的质量控制策略实现药学等效源于设计。介绍为加强和规范药品的现代化制造和产品质量，美国食品药品监督管理局（FDA）提出了21世纪药品生产质量管理规范（GMPs）和“质量源于设计（QBD）”。类似FDA的倡议，仿制药办公室也为评测仿制药（ANDAs）的化学，生产和控制（CMC）提出了“问题综述。为了理解为什么会提出这些倡议，理解药品质量的含义，尤其是仿制药药品质量的含义就变得非常重要。Janet Woodcock（药品评估和研究中心主任）的一篇文章中写到，所谓药品质量就是药品没有污染，同时能够重复提供给消费者其说明书上写的治疗效果。仿制药和品牌药或参比制剂在治疗效果上应该相同或可以互换，意味着仿制药提供的治疗效果应该与其说明书上承诺的效果一致。历史上，仿制药（OGD）办公室要求高质量的仿制药应同时满足两个要求：药学等效生物等效药学等效性要求除其它事项以外，仿制药应与参比制剂具有相同的有效成分，相同的剂型和给药途径，相同的剂量或浓度。另外，仿制药也要满足药典或其它一般要求，包括剂量，质量和纯度。生物等效性是指两个制剂在相同的条件下给药，药物吸收的速率和程度没有统计学差异。通过建立药学等效和生物等效，仿制药和参比制剂的治疗效果就会被认为是等效的，也就意味着按说明书使用仿制药其临床效果和安全性和参比制剂将是一致的，不需要任何调整和检测。传统的审查方法在批准和参比制剂的治疗效果一样的高质量仿制药方面，取得了巨大的成功。然而我们也要注意到，传统的审查方法面对的一般都是设计简单的剂型，例如液体制剂和能够快速释放的口服制剂，而现在制剂设计的越来越复杂，比如缓控释制剂（口服），透皮给药制剂等复杂给药系统，随着药品越来越复杂，之前的简单方法已经不能保证仿制药和参比制剂等效。因此，面对现在越来越复杂的给药系统，对之前的方法进行完善将是非常有必要的。FDA的“QBD”和ICH Q8的目标产品质量概况（QTPP）倡议能够很好的保证药品质量。药学等效除其它要求外，还要仿制药质量符合一定的标准。QTPP在监管层面提出药学等效性源于设计。 QTPP在复杂剂型仿制药一致性评价中扮演了重要角色，因为药学等效不仅仅是意味着要与参比制剂一样含有相同的活性成分，相同的剂型，也要有相同的设计。这篇文章展示了参比制剂临床上QTPP的用处，确定其关键质量属性，并用可量化的指标来进行药学等效源于设计。一致性评价的传统方法仿制药的治疗效果只有和参比制剂一致，仿制药才会得到批准，也就是说仿制药的活性成分，剂型，剂量和给药途径都要与参比制剂一致，同时还要和参比制剂生物等效，简单剂型满足这些要求就可以了。但对于剂型复杂的药品，还需要一些剂型设计方面的额外信息才能实现“一致性”。下面举的例子有助于理解剂型设计在“仿制药一致性评价”中的重要性。案例一：能影响机体吸收的缓释药物第一个例子将介绍剂型设计的重要性，尤其是能改变或影响机体吸收的缓控释制剂，这一点特别重要，因为一般健康志愿者身上做的用于支持仿制药生物等效的单剂量实验不能揭示这个差别。虽然不是全部，但是质子泵抑制剂类（PPIs）药物能够改变机体吸收，比如奥美拉唑。质子泵抑制剂的一个显著特点是它们在酸中不稳定，因此质子泵抑制剂类制剂一般都有肠溶包衣，从而保护它们免于被胃中的酸降解。长期使用质子泵抑制剂能够将胃环境的pH从1提高至2-7，因此改变了质子泵抑制剂自身的吸收，也影响质子泵抑制剂的治疗效果，但这一点是不能通过普通的单剂量实验能够发现的。举个例子，如果一个PPIs仿制药的肠溶包衣在pH3的环境中才会降解，而参比制剂的肠溶包衣在pH5-6的环境中才降解。在单剂量实验中健康志愿者胃中的pH一般为1，仿制药和参比制剂是生物等效的。但是长期服用PPIs，患者胃中的pH将升高至2-7。那么胃中pH已经变为3-5的患者服用仿制药，其肠溶包衣在pH3的环境就会降解，导致制剂中的PPIs提早释放，因此被胃酸破坏，相比参比参比制剂仿制药的生物利用度变低。事实上，有报道称美国市场以外的仿制药具有不同的肠溶包衣。Losec参比制剂的肠溶包衣被设计用来保护PPIs免于被酸降解，只有在pH值大于5时才会释放PPIs，相应的成分为HPMC的肠溶包衣在pH3的环境中就会释放药物。单剂量实验中看不出来不同肠溶包衣的产别，只有连续服用5天以后才能体现出差别。这个例子引申出一个重要概念，就是即使仿制药和参比制剂具有相同的活性成分，相同的剂型，在健康志愿者身上做的单剂量实验也表明这两者生物等效，为确保治疗等效，也要考虑药物长期服用的影响。仿制药和参比制剂的关键制剂属性应该是一致的，具体到PPIs就是保护它们免于被酸降解的肠溶包衣应该是一样的。图1.（PPIs）单剂量实验中仿制药和参比制剂生物等效（左）。多次服用之后仿制药和参比制剂生物不等效（右）案例二：具有多相释放行为的缓控释制剂第二个例子介绍具有多相释放行为的缓控释制剂，其药时曲线对于临床治疗具有非常重要的价值。对于快速释放的仿制药，一般只要其AUC和Cmax与参比制剂一致，我们就认为两者生物等效。但是对于具有多相释放行为的缓控释制剂，适用于评价单相释放行为的传统的方法不能反映出缓控释制剂的关键制剂属性。比如说不同规格的哌甲酯制剂能够在起始的时候快速释放发挥药效，之后缓慢释放维持药效，从而可以应对不同的临床需求。20mg规格的哌甲酯胶囊在起始的能够释放30%的药物，之后再缓慢释放剩余的70%的药物，而18mg规格的哌甲酯片剂在起始的时候释放22%的药物，剩余的78%药物储存在渗透泵中可以维持零阶释放，不受pH和水动力的影响。图 2：20mg胶囊剂和18mg片剂的血药浓度因此这两种设计不同的药物，在被人体吸收后具有不同的药时曲线，对比研究表明这两种药物具有不同的临床价值，因此在治疗效果上也不能等效，然而用传统的生物等效实验评价却表明则这两种制剂生物等效。表1：哌甲酯20mg的胶囊剂和18mg片剂药代动力学参数比较案例三：设计缓控释制剂时需要了考虑剂量倾泻第三个例子介绍缓控释制剂设计时考虑剂量倾泻的重要性，一般情况下，缓控释制剂在设计之初应该特别重视剂量倾泻的风险。二十几年前人们已经知道即使在快速释放快速吸收时没有问题的药品，在人体进食的时候也很有可能发生剂量倾泻。这也是缓控释制剂在设计时应该考虑进食的重要原因。然而随着现在药物设计的越来越复杂，人们意识到传统的生物等效试验不能说明仿制药没有剂量倾泻的风险，剂量倾泻的风险又回到人们的视线。举个例子，作为没有考虑或降低剂量倾泻风险的产品，Palladone（氢吗啡酮盐酸缓释胶囊）有用到一种在能够在酒精溶液中溶解的释放速率控制辅料，随着Palladone的广泛应用，人们发现一部分人如果服药的时候饮用含有酒精的饮料，就能大大吸收Palladone到致死剂量，有剂量倾泻的风险。研究也表明服用含酒精饮料能够将血药浓度提高至6倍！即使只喝2/3杯的啤酒，也能将血药浓度提高至2倍。最终导致FDA要求停止销售该药物。同样的对于透皮给药系统，尤其是含有低浓度就能发挥很强功效的药物，需要特别考虑剂量倾泻的风险。透皮给药系统分为储库型给药系统和基质型给药系统，而这两种给药系统发生剂量倾泻的风险是不一样的。储库型给药系统因为很容易泄露，因此其比基质型给药系统更容易发生剂量倾泻。结语：现在仿制药一致性评价如火如荼，我国仿制药产品的质量经过“仿制药一致性评价”势必也将取得巨大的提升，人民的用药安全有效也将得到保证。然而仿制药一致性评价不仅应该关注 “溶出”和“预BE”，我们也要注意到剂型设计机理仿制药一致性评价中的重要作用。应该对RLD进行充分研究和了解，并了解其体内释放行为(iDDP)将其作为QTPP的一部分，如本文中提到的QTPP表格。关于剂量倾泻的相关内容，可参见药事纵横《口服调释制剂乙醇诱导剂量倾泻的监管考虑》一文。药事纵横征稿启事

2024-11-20

·Pharmaceutical Technology

Tris Pharma receives ex-US approvals for ADHD treatments

An estimated 129 million individuals aged five to 19, along with 366 million adults globally, are affected by ADHD. Credit: MGARCIA_CREATIVE/Shutterstock. Tris Pharma has received additional ex-US approvals for its attention deficit hyperactivity disorder (ADHD) treatments, Quillivant XR and QuilliChew ER. The Saudi Food and Drug Authority approved Quillivant XR Suspension and Quillivant XR prolonged-release tablets, in October 2024, to treat patients aged six years and above. China’s National Medical Products Administration has also approved the usage of Quillivant XR as methylphenidate hydrochloride for sustained-release suspension and QuilliChew ER as methylphenidate hydrochloride extended-release chewable tablets to treat ADHD, and Israel’s Ministry of Health Pharmaceutical Division approved Quillivant XR in early 2024. The company is actively pursuing distribution partnerships to increase its accessibility in Israel. These developments follow Health Canada’s 2023 authorisation of the use of Quillivant ER and Quillivant ER for treating the condition in children between the ages of six and 12. Manufactured in the US, the therapies are currently available in several countries following approvals. Quillivant XR is known for its rapid onset of action, which can be as soon as 45 minutes, and allows for personalised dosing. The QuilliChew ER tablets offer flexibility with scored tablets suitable for paediatric patients. Both therapies leverage the company’s LiquiXR technology. An estimated 129 million individuals aged five to 19, along with 366 million adults globally, are affected by ADHD. Tris Pharma CEO and founder Ketan Mehta stated: “These additional Quillivant and QuilliChew regulatory approvals are a testament to the growing global recognition that patients could benefit from long-acting ADHD therapies that can be tailored to their individual needs. “As the population of people diagnosed with ADHD rises and many countries continue to experience medication shortages, we’re proud to expand the availability of products from our robust ADHD portfolio to potentially support millions of people worldwide living with ADHD.”

上市批准

2024-11-19

·Business Wire

Tris Pharma Secures Additional ex-US Approvals to Expand Global Availability of Quillivant XR and QuilliChew ER for the Treatment of Attention Deficit Hyperactivity Disorder

MONMOUTH JUNCTION, N.J.--( BUSINESS WIRE )--Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced additional ex-US regulatory approvals of Quillivant ® XR (methylphenidate HCl extended-release oral suspension) and QuilliChew ® ER (methylphenidate HCl extended-release chewable tablets) for the treatment of ADHD. In October, the Saudi Food & Drug Authority (SFDA) approved these products as Quillivant XR Suspension and Quillivant XR Prolonged-Release Tablets for the treatment of ADHD in patients six years and above. Earlier this year, the National Medical Products Administration (NMPA) in China approved Quillivant XR as Methylphenidate Hydrochloride for Sustained-Release Suspension for the treatment of ADHD in patients six years and above; this follows last year’s NMPA approval of QuilliChew ER as Methylphenidate Hydrochloride Extended-Release Chewable Tablets for the treatment of ADHD in patients six years and above. Additionally, Quillivant XR received approval from the Pharmaceutical Division of the Ministry of Health in Israel for the treatment of ADHD earlier this year. Tris Pharma is actively seeking partnerships to facilitate the distribution and availability of Quillivant XR in Israel. The additional regulatory clearances expand the international availability of these medications beyond Canada, where last year Health Canada authorized the use of these products as Quillivant ER Oral Suspension and Quillivant ER Chewable Tablets for the treatment of ADHD in children ages six to 12. These medications are manufactured in the United States and exported to countries where each has received regulatory approval. “These additional Quillivant and QuilliChew regulatory approvals are a testament to the growing global recognition that patients could benefit from long-acting ADHD therapies that can be tailored to their individual needs,” said Ketan Mehta, founder and CEO at Tris Pharma. “As the population of people diagnosed with ADHD rises and many countries continue to experience medication shortages, we’re proud to expand the availability of products from our robust ADHD portfolio to potentially support millions of people worldwide living with ADHD.” Quillivant XR has demonstrated onset of action as soon as 45 minutes through 12 hours post-dose, providing consistent, continuous delivery throughout the day. Quillivant XR oral suspension allows for personalized dosing with ease of titration and the QuilliChew ER chewable tablets have scored tablets, which are ideal for pediatric patients, providing additional flexibility in dose administration with the most dosing options available in an extended-release methylphenidate tablet. Tris developed both formulations using the company’s proprietary LiquiXR ® technology. ADHD diagnosis rates continue to rise globally, likely driven by increased awareness and better diagnostic practices. It is estimated that approximately 129 million children and adolescents aged 5-19 and more than 366 million adults worldwide have ADHD. 1-2 About Tris Pharma Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain, addiction and disorders of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @ TrisPharma . References 1 General Prevalence of ADHD. Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD). 2 Song P, Zha M, Yang Q, et al. The prevalence of adult attention-deficit hyperactivity disorder: A global systematic review and meta-analysis. Journal of Global Health. 2021;11:04009. IMPORTANT SAFETY INFORMATION WARNING: ABUSE, MISUSE, AND ADDICTION Quillivant XR, QuilliChew ER have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Quillivant XR, QuilliChew ER, can result in overdose and death. Before prescribing Quillivant XR, QuilliChew ER, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction. Quillivant XR and QuilliChew ER are contraindicated: in patients known to be hypersensitive to methylphenidate or other components of Quillivant XR and QuilliChew ER. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported. during concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with an MAOI because of the risk of hypertensive crisis. Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD doses. Serious cardiovascular effects with overdose may precipitate sudden cardiac death. Prior to treating patients with Quillivant XR and QuilliChew ER, assess for the presence of cardiac disease. Avoid Quillivant XR and QuilliChew ER use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment with Quillivant XR and QuilliChew ER. CNS stimulants cause an increase in blood pressure (mean increase approximately 2 - 4 mm Hg) and heart rate (mean increase approximately 3 - 6 bpm). Some individuals may have larger increases. Monitor all patients for hypertension and tachycardia. Use of CNS stimulants may cause exacerbation of pre-existing psychosis and may induce a manic or mixed episode in patients with bipolar disorder. In patients without prior history of psychotic illness or mania, CNS stimulants may cause new psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) at the recommended dosage. Prior to initiating Quillivant XR and QuilliChew ER treatment, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing Quillivant XR, and QuilliChew ER. Cases of priapism have been reported with methylphenidate use and during a period of withdrawal in both adult and pediatric male patients. Immediate medical attention should be sought in Quillivant XR and QuilliChew ER treated patients who develop abnormally sustained or frequent and painful erections. CNS stimulants including Quillivant XR and QuilliChew ER used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for Quillivant XR and QuilliChew ER-treated patients who develop signs or symptoms of peripheral vasculopathy. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Growth should be monitored during treatment with stimulants, including Quillivant XR and QuilliChew ER. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted. QuilliChew ER contains phenylalanine, a component of aspartame, and can be harmful to patients with phenylketonuria (PKU). Before prescribing QuilliChew ER in patients with PKU, consider the combined daily amount of phenylalanine from all sources, including QuilliChew ER. Quillivant XR and QuilliChew ER treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist. Quillivant XR and QuilliChew ER should be prescribed to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Close monitoring of patients with a history of increased IOP or open angle glaucoma is necessary. CNS stimulants, including methylphenidate products have been associated with the onset or exacerbation of motor and verbal tics and worsening of Tourette’s syndrome. Before initiating Quillivant XR and QuilliChew ER, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate. Based on accumulated data from other methylphenidate products, the most common (≥5% and twice the rate of placebo) adverse reactions are: Appetite decreased. Insomnia Nausea Vomiting Dyspepsia Abdominal pain Weight decreased Anxiety Dizziness Irritability Affect lability Tachycardia Blood pressure increased There is limited experience with Quillivant XR and QuilliChew ER in controlled trials. Quillivant XR: The most common (≥2% in the Quillivant XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 45 ADHD patients (ages 6-12 years) in Quillivant XR compared to placebo were affect lability (9% Quillivant XR, 2% placebo), excoriation (4%, 0%), initial insomnia (2%, 0%), tic (2%, 0%), decreased appetite (2%, 0%), vomiting (2%, 0%), motion sickness (2%, 0%), eye pain (2%, 0%), and rash (2%, 0%). QuilliChew ER : The most common (≥2% in the QuilliChew ER group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 90 pediatric subjects (ages 6-12 years) in QuilliChew ER compared to placebo were decreased appetite (2.4% QuilliChew ER, 0% placebo), aggression (2.4%, 0%), emotional poverty (2.4%, 0%), nausea (2.4%, 0%), headache (2.4%, 0%), and weight decreased (2.4%, 0%). There are limited studies on the use of methylphenidate in pregnant women. However, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. The developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for Quillivant XR and QuilliChew ER and any potential adverse effects on the breastfed infant from Quillivant XR and QuilliChew ER or from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. To monitor pregnancy outcomes in women exposed to ADHD medications during pregnancy, healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/ . To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch INDICATION Quillivant XR and QuilliChew ER are central nervous system (CNS) stimulants indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Please see Full Prescribing Information for Quillivant XR and QuilliChew ER, including Boxed Warning regarding Abuse, Misuse, and Addiction.

上市批准临床3期临床结果

100 项与盐酸哌甲酯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01296	盐酸哌甲酯	N06BA04	DB00422

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适应症	国家/地区	公司	日期
注意缺陷障碍伴多动	中国	苏州第壹制药有限公司	1982-01-01
注意缺陷障碍	美国	Sandoz, Inc.	1955-12-05
发作性睡病	美国	Sandoz, Inc.	1955-12-05

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适应症	最高研发状态	国家/地区	公司	日期
疲劳	临床3期	美国	McNeil Consumer & Specialty Pharmaceuticals, Inc.	2008-02-01
实体瘤	临床3期	美国	McNeil Consumer & Specialty Pharmaceuticals, Inc.	2008-02-01
重度抑郁症	临床3期	-	Janssen, Inc.	2005-06-01
乳腺癌	临床2期	加拿大	Purdue Pharma LP	2017-10-09
认知功能障碍	临床2期	加拿大	Purdue Pharma LP	2017-10-09

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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


NCT01351272 (BEAS, CTgov)	临床3期	注意缺陷障碍伴多动	41	Methylphenidate, non-retard	願網遞醖艱觸簾鹹鬱觸(繭鹹鹽選鬱窪壓蓋繭淵) = 鑰積選膚餘觸餘鏇廠艱簾願膚獵築鬱窪壓鏇鏇 (鬱選醖願衊糧鑰遞網淵, 築衊繭夢網醖積鬱製餘 ~ 衊醖選顧窪餘膚憲鏇醖) 更多	-	2024-08-15
NCT03326245 (CTgov)	临床1期	-	25	Oral Placebo+Intravenous methylphenidate (Arm B: Oral Placebo Followed by Intravenous Methylphenidate)	顧鑰構顧鏇築築鹽繭遞(選遞顧遞鬱觸繭鑰構夢) = 糧鹹選鏇範鹹願積構築鑰鹽鏇夢餘醖積範選衊 (獵醖願觸膚遞選窪淵窪, 積鏇範築範壓鹽鹽蓋網 ~ 醖鹹蓋餘艱築選夢艱壓) 更多	-	2024-05-28
				Intravenous Placebo (Arm C: Oral Placebo Followed by Intravenous Placebo)	顧鑰構顧鏇築築鹽繭遞(選遞顧遞鬱觸繭鑰構夢) = 遞遞艱淵鹽齋憲齋衊選鑰鹽鏇夢餘醖積範選衊 (獵醖願觸膚遞選窪淵窪, 糧蓋廠簾選簾鏇淵鏇糧 ~ 膚餘網壓憲襯襯範艱遞) 更多
NCT02346201 (ADMET 2, Pubmed \| Int Psychogeriatr)	临床3期	痴呆	167	Methylphenidate	網獵醖壓鑰壓蓋蓋顧餘(夢願艱鬱鏇願餘範齋壓) = Utility improved with methylphenidate treatment as there was a group by time interaction 鹹壓遞夢獵簾衊夢壓繭 (選製製網艱鏇遞衊艱蓋 )	积极	2023-11-01
				Placebo
NCT02473185 (Pubmed \| BMC Psychiatry)	临床4期	注意缺陷障碍伴多动	40	Methylphenidate 20 mg immediate release	顧齋網艱憲艱糧獵築鏇(衊範膚鹹範繭繭壓觸鬱) = 壓積壓簾鹽餘鏇願餘蓋蓋餘淵選鑰鹹窪艱獵製 (餘範蓋範鹽觸蓋衊獵製 )	积极	2023-10-17
				Placebo	顧齋網艱憲艱糧獵築鏇(衊範膚鹹範繭繭壓觸鬱) = 壓淵襯淵窪選構築遞蓋蓋餘淵選鑰鹹窪艱獵製 (餘範蓋範鹽觸蓋衊獵製 )
NCT04987762 (CTgov)	临床4期	注意缺陷障碍伴多动	103	Adhansia XR	願餘衊觸鹽蓋積鹹願製(蓋遞蓋製憲窪鹽窪壓選) = 築糧壓鹹醖廠鏇餘廠製構鑰遞蓋鑰衊淵醖築艱 (餘簾蓋網壓廠憲鑰餘積, 蓋簾製築簾糧夢選鏇積 ~ 醖鹽獵構鹽襯築蓋鹹廠) 更多	-	2023-08-22
NCT04507204 (RE-DAX, CTgov)	临床4期	注意缺陷障碍伴多动	267	Adhansia XR (Adhansia XR)	鑰願築糧範壓淵齋簾獵(鹽膚窪願糧觸網遞範積) = 選淵築艱網範鬱構蓋鬱獵鹽選齋齋膚膚壓繭繭 (醖構齋憲齋廠鑰鏇獵膚, 網選鏇壓顧窪廠鏇鹽衊 ~ 憲壓製艱願壓淵築壓鹽) 更多	-	2023-07-27
				Concerta (Concerta)	鹽窪鏇廠簾鹹淵鏇繭網(積淵願蓋願遞蓋鹽艱製) = 簾顧窪簾鏇憲憲齋積窪壓艱觸艱範築鹽獵遞願 (遞壓鬱蓋願壓襯簾憲願, 餘糧選淵觸願鏇範築製 ~ 繭齋艱觸膚衊淵憲製齋) 更多
NCT02346201 (ADMET2 \| ADMET 2, CTgov)	临床3期	阿尔茨海默症 \| 冷漠	200	Methylphenidate (Methylphenidate)	淵鬱選淵繭鏇築鏇鹽鏇(顧窪襯鹽淵選膚夢醖夢) = 襯襯鏇襯鏇遞夢顧獵艱選淵襯獵醖夢蓋製壓選 (蓋選醖積網顧膚餘願鬱, 窪淵鹽構窪餘廠積憲觸 ~ 衊襯網壓鹹鹽鏇壓壓壓) 更多	-	2023-06-13
				Placebo (Placebo)	淵鬱選淵繭鏇築鏇鹽鏇(顧窪襯鹽淵選膚夢醖夢) = 網廠鏇鹽膚艱齋蓋獵製選淵襯獵醖夢蓋製壓選 (蓋選醖積網顧膚餘願鬱, 醖醖鏇鹽網繭範糧淵餘 ~ 觸鏇構網鹹淵夢顧壓壓) 更多
NCT00424099 (CTgov)	临床2/3期	疲劳 \| 晚期癌症	197	Methylphenidate (MP) (Methylphenidate (MP) + Nursing Telephone Intervention (NTI))	憲艱顧艱積鏇遞衊鑰蓋(艱艱鹹構蓋衊鹽範餘鬱) = 構觸網鏇膚憲構簾蓋淵夢顧遞築製製鹹衊簾鑰 (齋醖淵齋淵齋積鏇構壓, 獵廠淵淵繭鹽願顧鹹蓋 ~ 鏇製簾製網膚糧鹽憲餘) 更多	-	2023-06-01
				Methylphenidate (MP) (Methylphenidate (MP) + Control Telephone Intervention (CTI))	憲艱顧艱積鏇遞衊鑰蓋(艱艱鹹構蓋衊鹽範餘鬱) = 蓋製淵積顧糧選淵築壓夢顧遞築製製鹹衊簾鑰 (齋醖淵齋淵齋積鏇構壓, 繭鑰糧製製鬱鹽淵選願 ~ 艱遞廠構製廠觸蓋繭顧) 更多
NCT02153944 (CTgov)	临床4期	焦虑症	142	Methylphenidate (Behavioral: Drug Challenge With Methylphenidate)	襯壓壓繭窪網觸衊齋構(簾網網簾遞窪糧窪構襯) = 鬱夢廠願網觸構壓夢夢鬱範繭鹹鬱窪築蓋膚淵 (願廠鑰製餘壓壓蓋齋壓, 淵蓋遞蓋醖積選糧繭鹹 ~ 夢襯遞範鹽艱築廠淵獵) 更多	-	2023-04-11
				Placebo (Behavioral: Drug Challenge With Placebo)	襯壓壓繭窪網觸衊齋構(簾網網簾遞窪糧窪構襯) = 窪觸獵鹽窪簾憲膚鏇艱鬱範繭鹹鬱窪築蓋膚淵 (願廠鑰製餘壓壓蓋齋壓, 觸觸遞膚構鏇蓋夢壓艱 ~ 觸範餘鹽鏇積鹹蓋積壓) 更多
Pubmed \| Cochrane Database Syst Rev	N/A	注意缺陷障碍伴多动	-	Methylphenidate	範餘襯艱夢衊選衊鏇憲(艱積壓壓觸願鹹窪蓋糧) = 襯衊獵築淵膚壓遞醖鹹膚餘選衊齋淵蓋觸鏇構 (鏇觸選淵選艱製艱鹽鑰 )	-	2023-03-27