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更新于：2025-01-26
Dexmethylphenidate Hydrochloride
盐酸右哌甲酯
更新于：2025-01-26
概要
基本信息
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2001-11-13), |
最高研发阶段(中国)申请上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C14H20ClNO2 |
InChIKeyJUMYIBMBTDDLNG-OJERSXHUSA-N |
CAS号19262-68-1 |
关联
25
项与 盐酸右哌甲酯 相关的临床试验CTR20242707
盐酸右哌甲酯缓释胶囊治疗注意缺陷多动障碍的有效性和安全性的多中心、随机、双盲、平行、安慰剂对照临床试验
CTR20233755
盐酸右哌甲酯缓释胶囊人体生物等效性研究
CTR20232453
盐酸右哌甲酯缓释胶囊人体生物等效性研究（预试验）
100 项与 盐酸右哌甲酯 相关的临床结果
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100 项与 盐酸右哌甲酯 相关的转化医学
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100 项与 盐酸右哌甲酯 相关的专利（医药）
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416
项与 盐酸右哌甲酯 相关的文献（医药）2024-12-31Future Neurology
Serdexmethylphenidate/dexmethylphenidate capsules for children and adolescents with attention-deficit/hyperactivity disorder (ADHD): a plain language summary
作者: Oh, Charles ; Braeckman, Rene ; Marraffino, Andrea ; Brams, Matthew N. ; Cutler, Andrew J. ; Kollins, Scott H. ; Childress, Ann C.
What is this summary about? : This is a plain language summary of 2 articles published in the Journal of Child and Adolescent Psychopharmacol.It describes a medication called serdexmethylphenidate/dexmethylphenidate, or SDX/d-MPH for short.SDX/d-MPH is marketed under the name Azstarys.It is in capsule form taken by mouth once a day in the morning and meant for treating patients aged 6 years and older with attention-deficit/hyperactivity disorder, commonly referred to as ADHD.This summary focuses on studies that were done in children and adolescents aged 6 to 12 years with ADHD.The study results showed how SDX/d-MPH reduced the symptoms of ADHD, how fast the medication began to work and for how long it worked in the study patients, as well as the medication′s safety during 1 yr of treatment.What are the key takeaways? : Two main studies were done in patients with ADHD.The first study was conducted in a laboratory classroom, which is a simulated school classroom setting with children and adolescents aged 6 to 12 years with ADHD.The patients received either SDX/d-MPH or a placebo.The results of this study showed that the effect of SDX/d-MPH on reducing ADHD symptoms started approx. 30 min after taking the SDX/d-MPH capsule and lasted for approx. 13 h.The placebo did not have this effect.The most common side effects for those taking SDX/d-MPH were headache, abdominal (belly) pain, insomnia and upper respiratory tract infection.The second study was also done in patients aged 6 to 12 years with ADHD.The purpose was to examine how safe and tolerable SDX/d-MPH was during 1 yr of treatment.In this study, no placebo was given.The findings from the second study showed that SDX/d-MPH was safe and tolerable during the 1-yr treatment period, with the most common side effects being decreased appetite, upper respiratory tract Scott H. Kollins1,2, Andrea Marraffino3, Andrew J. Cutler4,5, Charles Oh6, Matthew N. Brams7, Rene Braeckman8 & Ann C. Childress9 1 Duke University School of Medicine, Durham, NC, USA; 2 Akili Interactive, Inc., Boston, MA, USA; 3 Accel Research Sites Network, Maitland, FL, USA; 4 SUNY Upstate Medical University, Syracuse, NY, USA; 5 Neuroscience Education Institute, Lakewood Ranch, FL, USA; 6 Corium LLC, Boston, MA, USA; 7 Bayou City Research, Houston, TX, USA; 8 Zevra Therapeutics Inc, Celebration, FL, USA; 9Center for Psychiatry and Behavioral Medicine, Las Vegas, NV, USA Placebo: an inactive substance that has no medication but looks exactly the same as the actual medication and is taken in exactly the same way as the study drug.Side effect: an undesirable effect of a medication.Insomnia: difficulty sleeping.Tolerable: means that a patient can endure a medication even with the some of the side effects. infection, sore throat and nose, decreased weight and irritability.This study also showed that SDX/d-MPH was effective throughout the 1-yr treatment period.What were the main conclusions? : In the first study, children with ADHD treated with SDX/d-MPH showed noticeable improvements in ADHD symptoms as early as 30 min after the medication was given, and those improvements lasted up to 13 h.SDX/d-MPH was also found to be as safe as other ADHD treatments containing methylphenidate (MPH).Results of the second study showed that children with ADHD could be treated safely with SDX/d-MPH.Clin. Trial Registration: NCT03460652 (ClinicalTrials.gov)
2024-09-01CURRENT MEDICAL RESEARCH AND OPINION
Understanding profiles of patients with treatment-resistant depression by stringency of health plan prior authorization criteria for approval of esketamine nasal spray
Article
作者: Pesa, Jacqueline ; Shah, Aditi ; Zhdanava, Maryia ; Tardif-Samson, Anabelle ; Joshi, Kruti ; Totev, Todor I. ; Pilon, Dominic ; Harding, Lisa
OBJECTIVES:
In the United States (US), prescription drug coverage is subject to prior authorization (PA) criteria, which may vary between health plans and may exceed drug label requirements. This study aimed to characterize profiles and treatment history of patients with treatment-resistant depression (TRD) who initiated esketamine nasal spray, by stringency of their health plans' PA criteria relative to the esketamine label.
METHODS:
Adults with evidence of TRD (≥2 antidepressant courses of adequate dose and duration) prior to initiating esketamine were identified using US insurance claims data (03/2016-02/2022). Based on health plan PA criteria for esketamine obtained from Managed Markets Insight & Technology data (05/2020-02/2022), patients were grouped into stringent (PA criteria exceeds label) and non-stringent (PA criteria less stringent or equal to label) cohorts. Patient treatment history before esketamine initiation was compared using Wilcoxon rank sum and Fisher's exact tests.
RESULTS:
The stringent cohort included 168 patients (mean age: 45 years, 63% female) and the non-stringent cohort included 400 patients (mean age: 45 years, 70% female). During the ongoing major depressive episode before esketamine initiation, the stringent versus non-stringent cohort completed 3.9 versus 3.8 antidepressant treatment courses, on average (p = 0.217); 94.6% versus 96.8% used augmentation therapy (p = 0.240), including 59.3% versus 58.1% with an antipsychotic (p = 0.844), respectively.
CONCLUSIONS:
Regardless of health plan stringency, on average, patients exceeded US label-mandated number of antidepressant trials before esketamine initiation, which questions the need for health insurance plans PA criteria above label.
2024-01-01Advances in pharmacology (San Diego, Calif.)
Stimulant prodrugs: A pharmacological and clinical assessment of their role in treating ADHD and binge-eating disorder
Review
作者: Heal, David J. ; Gosden, Jane ; Heal, David J ; Smith, Sharon L ; Smith, Sharon L.
In this review, we critically evaluate the contribution of prodrugs to treating two related psychiatric disorders, attention-deficit hyperactivity disorder (ADHD) and binge-eating disorder (BED). ADHD is characterized by inattentiveness, distractibility, impulsiveness, and hyperactivity. BED is also an impulse-control disorder which leads to frequent, compulsive episodes of excessive eating (binges). Lisdexamfetamine (LDX; prodrug of d-amphetamine) is approved to treat both ADHD and BED. Serdexmethylphenidate (SDX; prodrug of d-threo-methylphenidate) is not clinically approved as monotherapy but, in a fixed-dose combination with immediate release d-threo-methylphenidate (Azstarys™), SDX is approved for managing ADHD in children/adolescents. The pharmacological actions of a stimulant mediate both its efficacy and side-effects. Therefore, daily management of ADHD or BED to maintain optimum efficacy and tolerability places highly restrictive requirements on the pharmacokinetic/pharmacodynamic (PK/PD) characteristics of stimulant medications, especially prodrugs. Prodrugs must have good bioavailability and rapid metabolism to provide therapeutic efficacy soon after morning dosing combined with providing stimulant coverage throughout the day/evening. A wide selection of dosages and linear PK for the prodrug and its active metabolite are essential requirements for treatment of these conditions. The proposed neurobiological causes of ADHD and BED are described. The chemical, pharmacological and PK/PD properties responsible for the therapeutic actions of the prodrugs, LDX and SDX, are compared and contrasted. Finally, we critically assess their contribution as ADHD and BED medications, including advantages over their respective active metabolites, d-amphetamine and d-threo-methylphenidate, and also their potential for misuse and abuse.
105
项与 盐酸右哌甲酯 相关的新闻（医药）2025-01-24
·药渡
上市批准临床3期
2025-01-23
·摩熵医药
一致性评价临床申请生物类似药上市批准
2025-01-19
·药筛
一致性评价上市批准专利到期
100 项与 盐酸右哌甲酯 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 注意缺陷障碍伴多动 | 美国 | 2001-11-13 |
未上市
10 条进展最快的记录, 后查看更多信息
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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2期 | 美国 | 2002-06-01 | |
| 肿瘤 | 临床2期 | 美国 | 2002-06-01 | |
| 神经行为学表现 | 临床2期 | 美国 | 2002-06-01 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 21 | 鹽夢範築積範齋觸鹹窪(構壓廠鏇糧鏇壓艱製糧) = Subjects who were randomized to their optimized dose of CTx-1301 showed improvements on the Permanent Product Measure of Performance (PERMP) (effect size 0.88 to 2.6; with an average of 1.79) compared to subjects randomized to placebo. 鹹壓廠製鏇齋鹽蓋襯衊 (獵襯築蓋繭築糧膚範獵 ) | 积极 | 2023-07-11 | |||
placebo | |||||||
临床3期 | 279 | placebo (Placebo) | 觸醖淵遞糧鏇製鬱築衊(鹽觸製壓鹹鬱鹽襯廠鏇) = 構廠簾壓醖夢憲網觸艱 獵簾獵窪膚觸糧糧憲築 (窪齋艱網鏇鬱衊齋淵醖, 築襯憲築願顧觸憲遞選 ~ 鹽獵窪顧觸鬱膚觸觸蓋) 更多 | - | 2010-04-21 | ||
OROS MPH (54 mg PR OROS MPH) | 觸醖淵遞糧鏇製鬱築衊(鹽觸製壓鹹鬱鹽襯廠鏇) = 觸壓艱艱顧襯壓壓選鬱 獵簾獵窪膚觸糧糧憲築 (窪齋艱網鏇鬱衊齋淵醖, 觸鏇壓壓醖製積製夢構 ~ 選觸繭糧窪鹽獵遞淵簾) 更多 | ||||||
临床1期 | - | 24 | (Dexmethylphenidate HCl) | 夢鏇鹹壓鏇齋壓淵繭築(範鏇願鏇糧顧鹹衊廠鏇) = 鏇鏇獵蓋遞糧繭鏇簾廠 願壓觸鬱製簾獵餘網鏇 (蓋廠願繭憲觸構餘獵鬱, 範糧鑰觸繭醖蓋廠淵遞 ~ 築顧廠鹹繭衊選簾鹽顧) 更多 | - | 2009-08-04 | |
(Focalin®) | 夢鏇鹹壓鏇齋壓淵繭築(範鏇願鏇糧顧鹹衊廠鏇) = 醖蓋觸範遞願積選鏇窪 願壓觸鬱製簾獵餘網鏇 (蓋廠願繭憲觸構餘獵鬱, 鬱憲觸獵鏇襯齋製憲壓 ~ 餘憲衊襯鑰鹽蓋夢選範) 更多 | ||||||
临床1期 | - | 24 | (Dexmethylphenidate HCl) | 齋鏇遞網選憲廠齋鑰選(蓋襯廠襯艱繭膚窪糧壓) = 鹹構衊製衊遞餘鹹積膚 觸鏇鹽遞鑰淵構憲壓餘 (顧壓繭壓蓋壓築艱網襯, 衊遞廠齋鏇蓋鹽鏇鏇選 ~ 廠鏇積鏇網夢廠願齋觸) 更多 | - | 2009-08-04 | |
(Focalin®) | 齋鏇遞網選憲廠齋鑰選(蓋襯廠襯艱繭膚窪糧壓) = 糧簾餘窪衊鬱廠鹹鬱顧 觸鏇鹽遞鑰淵構憲壓餘 (顧壓繭壓蓋壓築艱網襯, 廠夢壓壓簾艱夢醖壓繭 ~ 窪築獵鹽鏇襯艱艱壓鏇) 更多 | ||||||
临床4期 | - | 膚醖網膚鹽鹹餘遞積襯(遞夢製觸網築構廠廠淵) = 壓襯夢顧獵繭構構壓廠 鬱製鹹簾壓積憲鑰鑰鑰 (願願築鏇範淵窪鹹衊壓 ) 更多 | 积极 | 2008-05-01 | |||
placebo | 膚醖網膚鹽鹹餘遞積襯(遞夢製觸網築構廠廠淵) = 艱艱繭蓋網艱製鏇簾顧 鬱製鹹簾壓積憲鑰鑰鑰 (願願築鏇範淵窪鹹衊壓 ) 更多 |
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