Randomized, Double-blind, Active & Placebo-controlled, 6-way Crossover Study of Abuse Potential of Oral Gabapentin Enacarbil IR Capsules With and Without Oxycodone in Healthy, Nondependent, Recreational Opioid Users

The purpose of this study is to assess the abuse potential of gabapentin enacarbil immediate release capsules taken alone and in combination with oxycodone in healthy adult, non-dependent, recreational opioid users.

开始日期2022-01-31

申办/合作机构

Arbor Pharmaceuticals, Inc.

NCT06097676

/ Completed临床4期

A Randomized, Double Blind, Active and Placebo Controlled, 5 Way Crossover Study to Determine the Abuse Potential of Orally Administered Gabapentin Enacarbil Immediate Release Capsules in Healthy, Nondependent Recreational Drug Users With Sedative Experience

The purpose of this study is to assess the abuse potential of gabapentin enacarbil in healthy adult, non-dependent, recreational drug users.

开始日期2021-09-28

申办/合作机构

Arbor Pharmaceuticals, Inc.

NCT03082755

/ Recruiting临床4期IIT

Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease

Nighttime agitation in persons with Alzheimer's disease causes patient suffering, distresses caregivers, and often results in prescriptions for harmful antipsychotics. Effective treatments are lacking because of limited knowledge of the etiology of nighttime agitation. The investigators propose a clinical trial to better elucidate whether a sleep disorder, restless legs syndrome, may be a mechanism for nighttime agitation, and if treatment with gabapentin enacarbil (Horizant®) reduces nighttime agitation, improves sleep, reduces restless legs syndrome behaviors, and reduces antipsychotic medications.

开始日期2017-07-01

申办/合作机构

The University of Texas at Austin

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100 项与加巴喷丁酯相关的临床结果

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100 项与加巴喷丁酯相关的转化医学

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100 项与加巴喷丁酯相关的专利（医药）

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项与加巴喷丁酯相关的文献（医药）

2025-05-01·Journal of the American Medical Directors Association

Treatment of Restless Legs Syndrome Improves Agitation and Sleep in Persons with Dementia: A Randomized Trial

Article

作者: Morrison, Janet D ; Fry, Liam M ; Hanlon, Alexandra L ; Gooneratne, Nalaka S ; Richards, Kathy C ; Britt, Katherine C ; Lozano, Alicia J ; Ji, Wenyan ; Bliwise, Donald L

OBJECTIVES:

Restless legs syndrome (RLS), a common, treatable, sensorimotor disorder of nighttime uncomfortable leg sensations that interfere with sleep, may prompt nighttime agitation in persons with dementia.

DESIGN:

This randomized trial was double-blind and placebo-controlled. Participants received a Food and Drug Administration-approved drug for RLS, gabapentin enacarbil (GEn) (Horizant) or placebo.

SETTING AND PARTICIPANTS:

Older adults (N = 147) with dementia due to Alzheimer's disease, nighttime agitation, and RLS, residing in long-term care or at home, participated.

METHODS:

The primary outcome was change from baseline to 8 weeks in nighttime agitation between 5 pm and 7 am on the Cohen-Mansfield Agitation Inventory Index, Direct Observation. Multivariable linear mixed effects regression models based on multiply imputed data were estimated on nighttime agitation and sleep, with treatment group, week, the 2-way interaction of group and week as predictors, and mean arterial pressure as a covariate based on baseline group imbalances.

RESULTS:

Mean age ± SD was 83.4 ± 9.1 years. Most were female (72.0%), white (92.3%), non-Hispanic (84.6%), and lived in nursing homes (76.9%). Nighttime agitation, by group over time, was significant at 8 weeks (estimate, -1.67; P = .003) and 2 weeks. Total sleep time (actigraphy) by group over time was significant at 8 weeks (estimate, 48.45; P = .026). Observed nighttime wake by group over time was significant at 2 (estimate, -12.54; P = .006) and 8 weeks (estimate, -11.12; P = .015). The number having ≥1 adverse events was 60 in the GEn group (81.1%) and 50 in the placebo group (68.5%); with 12 serious adverse events in placebo and 10 in the GEn group. The GEn group had a trend toward more falls (P = .066).

CONCLUSIONS AND IMPLICATIONS:

Our findings suggest a novel approach for nighttime agitation in persons with dementia: assessing for RLS and initiating interventions. Larger and longer trials are needed.

2025-03-25·ALCOHOL AND ALCOHOLISM

Identifying responders to gabapentin for the treatment of alcohol use disorder: an exploratory machine learning approach.

Article

作者: Cruz, Alondra ; Montoya, Amanda K ; Baskerville, Wave-Ananda ; Grodin, Erica N ; Donato, Suzanna ; Ray, Lara A

BACKGROUND:

Gabapentin, an anticonvulsant medication, has been proposed as a treatment for alcohol use disorder (AUD). A multisite study tested gabapentin enacarbil extended-release (GE-XR; 600 mg/twice a day), a prodrug formulation, combined with a computerized behavioral intervention, for AUD. In this multisite trial, the gabapentin GE-XR group did not differ significantly from placebo on the primary outcome of percent of subjects with no heavy drinking days. Despite the null findings, there is considerable interest in using machine learning methods to identify responders to GE-XR. The present study applies interaction tree machine learning methods to identify positive and iatrogenic (i.e. individuals who responded better to placebo than to GE-XR) treatment responders in the trial.

METHODS:

Baseline characteristics taken from the multisite trial were examined as potential moderators of treatment response using qualitative interaction trees (QUINT; N = 338; 223 M/115F). QUINT models are an exploratory decision tree approach that iteratively splits the data into leaves based on predictor variables to maximize a specific criterion.

RESULTS:

Analyses identified key factors that are associated with the efficacy (or iatrogenic effects) of GE-XR for AUD. Such factors are baseline drinking levels, motivation for change, confidence in their ability to reach drinking goals (i.e. self-efficacy), cognitive impulsivity, and baseline anxiety levels.

CONCLUSION:

Baseline drinking levels and anxiety levels may be associated with the protracted withdrawal syndrome, previously implicated in the clinical response to gabapentin. However, these analyses underscore motivation for change and self-efficacy as predictors of clinical response to GE-XR, suggesting these established constructs should receive further attention in gabapentin research and clinical practice. Multiple studies using different machine learning methods are valuable as these novel analytic tools are applied to medication development for AUD.

2025-01-01·Journal of Clinical Sleep Medicine

Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline

Review

作者: Scharf, Matthew T. ; Koo, Brian B. ; Falck-Ytter, Yngve ; DelRosso, Lourdes M. ; Shelgikar, Anita V. ; Trotti, Lynn Marie ; Winkelman, John W. ; Kazmi, Uzma ; Berkowski, J. Andrew ; Zak, Rochelle S. ; Walters, Arthur S. ; Sharon, Denise

INTRODUCTION:

This guideline establishes clinical practice recommendations for treatment of restless legs syndrome (RLS) and periodic limb movement disorder (PLMD) in adults and pediatric patients.

METHODS:

The American Academy of Sleep Medicine (AASM) commissioned a task force of experts in sleep medicine to develop recommendations and assign strengths based on a systematic review of the literature and an assessment of the evidence using the grading of recommendations assessment, development, and evaluation methodology. The task force provided a summary of the relevant literature and the certainty of evidence, the balance of benefits and harms, patient values and preferences, and resource use considerations that support the recommendations. The AASM Board of Directors approved the final recommendations.

GOOD PRACTICE STATEMENT:

The following good practice statement is based on expert consensus, and its implementation is necessary for the appropriate and effective management of patients with RLS.1. In all patients with clinically significant RLS, clinicians should regularly test serum iron studies including ferritin and transferrin saturation (calculated from iron and total iron binding capacity). Testing should ideally be administered in the morning avoiding all iron-containing supplements and foods at least 24 hours prior to blood draw. Analysis of iron studies greatly influences the decision to use oral or intravenous (IV) iron treatment. Consensus guidelines, which have not been empirically tested, suggest that supplementation of iron in adults with RLS should be instituted with oral or IV iron if serum ferritin ≤ 75 ng/mL or transferrin saturation < 20%, and only with IV iron if serum ferritin is between 75 and 100 ng/mL. In children, supplementation of iron should be instituted for serum ferritin < 50 ng/mL with oral or IV formulations. These iron supplementation guidelines are different than for the general population.2. The first step in the management of RLS should be addressing exacerbating factors, such as alcohol, caffeine, antihistaminergic, serotonergic, antidopaminergic medications, and untreated obstructive sleep apnea.3. RLS is common in pregnancy; prescribers should consider the pregnancy-specific safety profile of each treatment being considered.

RECOMMENDATIONS:

The following recommendations are intended as a guide for clinicians in choosing a specific treatment for RLS and PLMD in adults and children. Each recommendation statement is assigned a strength ("strong" or "conditional"). A "strong" recommendation (ie, "We recommend…") is one that clinicians should follow under most circumstances. The recommendations listed below are ranked in the order of strength of recommendations and grouped by class of treatments within each PICO (Patient, Intervention, Comparator, Outcome) question. Some recommendations include remarks that provide additional context to guide clinicians with implementation of this recommendation.

ADULTS WITH RLS:

1. In adults with RLS, the AASM recommends the use of gabapentin enacarbil over no gabapentin enacarbil (strong recommendation, moderate certainty of evidence).2. In adults with RLS, the AASM recommends the use of gabapentin over no gabapentin (strong recommendation, moderate certainty of evidence).3. In adults with RLS, the AASM recommends the use of pregabalin over no pregabalin (strong recommendation, moderate certainty of evidence).4. In adults with RLS, the AASM recommends the use of IV ferric carboxymaltose over no IV ferric carboxymaltose in patients with appropriate iron status (see good practice statement for iron parameters) (strong recommendation, moderate certainty of evidence).5. In adults with RLS, the AASM suggests the use of IV low molecular weight iron dextran over no IV low molecular weight iron dextran in patients with appropriate iron status (see good practice statement for iron parameters) (conditional recommendation, very low certainty of evidence).6. In adults with RLS, the AASM suggests the use of IV ferumoxytol over no IV ferumoxytol in patients with appropriate iron status (see good practice statement for iron parameters) (conditional recommendation, very low certainty of evidence).7. In adults with RLS, the AASM suggests the use of ferrous sulfate over no ferrous sulfate in patients with appropriate iron status (see good practice statement for iron parameters) (conditional recommendation, moderate certainty of evidence).8. In adults with RLS, the AASM suggests the use of dipyridamole over no dipyridamole (conditional recommendation, low certainty of evidence).9. In adults with RLS, the AASM suggests the use of extended-release oxycodone and other opioids over no opioids (conditional recommendation, moderate certainty of evidence).10. In adults with RLS, the AASM suggests the use of bilateral high-frequency peroneal nerve stimulation over no peroneal nerve stimulation (conditional recommendation, moderate certainty of evidence).11. In adults with RLS, the AASM suggests against the standard use of levodopa (conditional recommendation, very low certainty of evidence).Remarks: levodopa may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).12. In adults with RLS, the AASM suggests against the standard use of pramipexole (conditional recommendation, moderate certainty of evidence).Remarks: pramipexole may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).13. In adults with RLS, the AASM suggests against the standard use of transdermal rotigotine (conditional recommendation, low certainty of evidence).Remarks: transdermal rotigotine may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).14. In adults with RLS, the AASM suggests against the standard use of ropinirole (conditional recommendation, moderate certainty of evidence).Remarks: ropinirole may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).15. In adults with RLS, the AASM suggests against the use of bupropion for the treatment of RLS (conditional recommendation, moderate certainty of evidence).16. In adults with RLS, the AASM suggests against the use of carbamazepine (conditional recommendation, low certainty of evidence).17. In adults with RLS, the AASM suggests against the use of clonazepam (conditional recommendation, very low certainty of evidence).18. In adults with RLS, the AASM suggests against the use of valerian (conditional recommendation, very low certainty of evidence).19. In adults with RLS, the AASM suggests against the use of valproic acid (conditional recommendation, low certainty of evidence).20. In adults with RLS, the AASM recommends against the use of cabergoline (strong recommendation, moderate certainty of evidence).

SPECIAL ADULT POPULATIONS WITH RLS:

21. In adults with RLS and end-stage renal disease (ESRD), the AASM suggests the use of gabapentin over no gabapentin (conditional recommendation, very low certainty of evidence).22. In adults with RLS and ESRD, the AASM suggests the use of IV iron sucrose over no IV iron sucrose in patients with ferritin < 200 ng/mL and transferrin saturation < 20% (conditional recommendation, moderate certainty of evidence).23. In adults with RLS and ESRD, the AASM suggests the use of vitamin C over no vitamin C (conditional recommendation, low certainty of evidence).24. In adults with RLS and ESRD, the AASM suggests against the standard use of levodopa (conditional recommendation, low certainty of evidence).Remarks: levodopa may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).25. In adults with RLS and ESRD, the AASM suggests against the standard use of rotigotine (conditional recommendation, very low certainty of evidence).Remarks: rotigotine may be used to treat RLS in patients who place a higher value on the reduction of restless legs symptoms with short-term use and a lower value on adverse effects with long-term use (particularly augmentation).

ADULTS WITH PLMD:

26. In adults with PLMD, the AASM suggests against the use of triazolam (conditional recommendation, very low certainty of evidence).27. In adults with PLMD, the AASM suggests against the use of valproic acid (conditional recommendation, very low certainty of evidence).

CHILDREN WITH RLS:

28. In children with RLS, the AASM suggests the use of ferrous sulfate over no ferrous sulfate in patients with appropriate iron status (see good practice statement for iron parameters) (conditional recommendation, very low certainty of evidence).

CITATION:

Winkelman JW, Berkowski JA, DelRosso LM, et al. Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2025;21(1):137-152.

项与加巴喷丁酯相关的新闻（医药）

2025-02-06

·化学经纬

书籍分享||新药化学全合成路线手册

内容介绍本书归纳和综述了新药的化学合成路线。覆盖范围为近5年美国FDA批准上市的新分子实体药共109个。针对每一个药物，本书给出了药物简介，药物化学结构信息，产品上市信息，药品专利保护和市场独占权保护信息，化学全合成路线和参考文献等。这些合成路线大多是目前制药工业中正在使用的化学合成工艺，有较高的实用性和学术价值。对参与反应的起始原料、中间体、反应产物都给出了详细的化学结构。每一步化学合成反应都给出了重要的化学试剂、催化剂、所使用的溶剂、合成反应条件及文献出处等。本书的特点是：作者从浩如烟海的科技文献中，精心挑选出最新、最有实用价值的合成方法，汇编成化学合成路线图，内容简洁，深入浅出，逻辑性强，容易理解，以最少的篇幅表达最多的技术信息，可帮助读者很快找到他们需要的药物合成方法及最可靠的原始科学论文。读者对象： 1.任何从事与化学合成、药物合成、精细化工相关专业的科研人员、企业管理人员。 2.有机化学专业、药学专业、生物制药专业等大专院校的高年级学生、研究生、教师及科研人员。 3.从事客户委托的药物原料与药物中间体合成的科研人员、企业管理人员。编辑推荐对于制药企业而言,一个好的药物全合成路线, 可以大大缩短生产周期,简化生产工艺,降低生产成本,节约能源,减少或消除对环境的化学污染与排放。本书为了顺应我国近年来生物制药及医药工业飞速发展的潮流编写的，详细介绍了近五年美国FDA批准上市的所有（109个）新分子实体药的化学全合成路线。这些全合成路线多数是国外制药厂目前正在使用的工艺，其经济效益及社会效益都是极为显著，因此本书既有较高的科学价值又有很大的实用性。作者简介陈清奇，旅美药学家和化学家，担任美国MedKoo生物医药科研公司总裁，同时兼任美国数家生物制药公司的技术顾问，中国国内数个大学的客座教授。研究领域为药物化学，纳米医学体外诊断技术。书籍目录 Abiraterone Acetate（醋酸阿比特龙）001 Aclidinium Bromide（阿克利溴铵）006 Afatinib（阿法替尼）009 Alcaftadine（阿卡他定）014 Alogliptin（阿格列汀）017 Apixaban（阿哌沙班）022 Apremilast（阿普斯特）028 Avanafil（阿伐那非）033 Axitinib（阿西替尼）038 Azilsartan Kamedoxomil（阿齐沙坦酯钾盐）044 Bazedoxifene（巴多昔芬）048 Bedaquiline（贝达喹啉）053 Belinostat（贝利司他）060 Boceprevir（波西普韦）064 Bosutinib（博舒替尼）071 Cabozantinib（卡博替尼）075 Canagliflozin（卡格列净）078 Carfilzomib（卡非佐米）083 Ceftaroline Fosamil（头孢洛林酯）087 Ceftolozane（噻呋特啰嗪）094 Ceritinib（色瑞替尼）098 Clobazam（氯巴占）101 Cobicistat（可比司他）104 Crizotinib（克里唑蒂尼）112 Dabigatran Etexilate Mesylate（甲磺酸达比加群酯）118 Dabrafenib（达拉菲尼）123 Dapagliflozin（达格列净）127 Dasabuvir（达沙布韦）132 Deferiprone（去铁酮）136 Dienogest（地诺孕素）138 Dolutegravir（度鲁特韦）141 Droxidopa（屈昔多巴）145 Efinaconazole（艾氟康唑）149 Eliglustat（依利格鲁司特）152 Elvitegravir（埃替格韦）155 Empagliflozin（依帕列净）161 Enzalutamide（恩杂鲁胺）166 Eribulin Mesylate（甲磺酸艾日布林）168 Eslicarbazepine Acetate（艾利西平醋酸酯）175 Estradiol Valerate（雌二醇戊酸酯）180 Ezogabine（依佐加滨）185 Finafloxacin（非那沙星）193 Fingolimod Hydrochloride（盐酸芬戈莫德）197 Florbetapir F 18（氟比他匹）205 Flutemetamol F 18（富特米他）211 Gabapentin Enacarbil（加巴喷丁恩那卡比）214 Gadobutrol（钆布醇）218 Gadoterate Meglumine（钆特酸葡甲胺）224 Ibrutinib（依鲁替尼）227 Icatibant（艾替班特）232 Idelalisib（艾代拉里斯）234 Indacaterol （茚达特罗）236 Ingenol Mebutate（巨大戟醇甲基丁烯酸酯）240 Ioflupane 123I（碘[123I]氟潘）242 Ivacaftor（依瓦卡特）247 Ledipasvir（雷迪帕韦）250 Linaclotide（利那洛肽）259 Linagliptin（利拉利汀）261 Lomitapide（洛美他派）267 Lorcaserin（氯卡色林）270 Lucinactant（芦西纳坦）274 Luliconazole（卢立康唑）276 Lurasidone（鲁拉西酮）279 Macitentan（马西替坦）283 Miltefosine（米替福新）286 Mipomersen Sodium（米泊美生钠）290 Mirabegron（米拉贝隆）292 Naloxegol（纳罗克格）296 Netupitant（奈妥吡坦）299 Nintedanib（尼达尼布）303 Olaparib（奥拉帕尼）307 Olodaterol（奥达特罗）311 Omacetaxine Mepesuccinate（高三尖杉酯碱）315 Ombitasvir（艾姆伯韦）319 Ospemifene（奥培米芬）323 Paritaprevir（帕瑞它韦）327 Pasireotide（帕瑞肽）331 Peramivir（帕拉米韦）333 Perampanel（吡仑帕奈）337 Pirfenidone（吡非尼酮）343 Pomalidomide（泊马度胺）345 Ponatinib（泊那替尼）351 Regorafenib（瑞戈非尼）355 Rilpivirine（利匹韦林）357 Riociguat（利奥西呱）366 Rivaroxaban（利伐沙班）370 Roflumilast（罗氟司特）378 Ruxolitinib（鲁索替尼）384 Simeprevir（司美匹韦）388 Sofosbuvir（索非布韦）396 Suvorexant（苏沃雷生）401 Tafluprost（他氟前列腺素）405 Tasimelteon（他司美琼）409 Tavaborole（它瓦波罗）413 Tedizolid Phosphate（磷酸特地唑胺）415 Telaprevir（替拉瑞韦）418 Teriflunomide（特立氟胺）426 Ticagrelor（替格瑞洛）430 Tofacitinib（托法替尼）438 Trametinib（曲美替尼）443 Umeclidinium（芜地溴铵）447 Vandetanib（凡德他尼）450 Vemurafenib（威罗菲尼）456 Vilanterol（维兰特罗）460 Vilazodone Hydrochloride（盐酸维拉佐酮）463 Vismodegib（维莫德吉）468 Vorapaxar（沃拉帕沙）470 Vortioxetine（沃替西汀）473 附录1本书使用的期刊名称缩写表477 附录2专利文献代码481 附录3美国药品专利中的用途代码定义484 附录4美国药品市场独占权代码定义530 附录5美国FDA于2010—2014批准上市的药物名单563 英文索引607 中文索引611 CAS登记号索引613 下载方式现在，这份资料分享给大家。小编在公众号设置了自动回复功能，在公众号后台回复关键词：新药全合成 ●书籍分享||有机氧化反应原理与应用 ●书籍分享||有机卤化反应原理及应用 ●推荐合成书籍【有机缩合反应原理与应用】 ●推荐合成书籍【有机环合反应原理与应用】 ●书籍分享||有机还原反应原理与应用 ●ChemDraw使用让你从化学菜鸟变成老鸟 ●干货分享||有机合成: 策略与控制 ●干货分享||有机合成工艺研发-副反应抑制法 ●基础有机化学(邢其毅)第3、4版教材+习题解析 ●ChemDrawV20最新版详细安装图文教程 ●干货分享||核磁共振二维谱 ●书籍分享||全合成中的经典:更多的目标、战略和方法 ●书籍分享||实用药物化学 ●书籍分享||基于模仿创新的小分子药物发明 ●书籍分享||制药工艺开发-目前的化学与工程挑战 ●书籍分享||手性合成:不对称反应及其应用(第5版) ●书籍分享||新药研发案例研究--明星药物如何从实验室走向市场 ●书籍分享||英汉·汉英化学化工词汇 ●书籍分享||有机化学结构与功能（第四版） ●书籍分享||过渡金属有机化学(原著第6版） ●重磅书籍分享||不对称催化基础 ●书籍分享||药物设计学-唐赟

上市批准高管变更

2024-12-02

·drugs

Guidelines Developed for Treatment of Restless Legs Syndrome

MONDAY, Dec. 2, 2024 -- In a clinical practice guideline issued by the American Academy of Sleep Medicine and published online Sept. 26 in the Journal of Clinical Sleep Medicine , recommendations are presented for the treatment of restless legs syndrome (RLS). John W. Winkelman, M.D., Ph.D., from Massachusetts General Hospital in Boston, and colleagues developed recommendations for treatment of RLS and periodic limb movement disorder in adults and pediatric patients. The researchers developed three good practice statements that were based on expert consensus. They recommend all clinicians should regularly test serum iron studies, including ferritin and transferrin saturation, in all patients with clinically significant RLS, ideally in the morning; analysis of these studies influences the decision to use oral or intravenous (IV) iron treatment. The authors also state that addressing exacerbating factors, including alcohol, caffeine, antihistaminergic, serotonergic, and anti-dopaminergic medications, should be the first step in RLS management. They note RLS is common in pregnancy and the pregnancy-specific safety profile of each treatment should be considered. Recommendations for adults with RLS include use of gabapentin enacarbil over no gabapentin enacarbil; use of gabapentin over no gabapentin; use of pregabalin over no pregabalin; and use of IV ferric carboxymaltose over no IV ferric carboxymaltose for those with appropriate iron status (strong recommendations; moderate certainty of evidence). In addition, there is a strong recommendation against use of cabergoline. "Guided by the best evidence in the scientific literature, we've provided recommendations that will improve the ability of clinicians to provide patient-centered care for people who have RLS," Winkelman said in a statement. One author disclosed ties to the pharmaceutical and medical device industries. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

2023-10-30

·药讯社

刚刚！卫健委发布“第三批鼓励仿制药品建议目录（41种）

为落实国务院办公厅《关于改革完善仿制药供应保障及使用政策的意见》有关制定仿制药品目录的部署和要求，2023年，国家卫生健康委、工业和信息化部、国家医保局和国家药品监管局、国家知识产权局等部门组织专家对国内专利即将到期尚未提出注册申请及临床供应短缺（竞争不充分）的药品进行遴选论证，提出了《第三批鼓励仿制药品建议目录》。现予以公示，公示5个工作日。如有异议，请通过以下电话予以反映。电话：（010）68792519 第三批鼓励仿制药品建议目录药物政策与基本药物制度司2023年10月30日附件第三批鼓励仿制药品建议目录序号药品名称英文名称剂型规格1贝美替尼binimetinib片剂15mg2伏环孢素voclosporin胶囊剂7.9mg3伊德利塞idelalisib片剂0.1g片剂0.15g4艾曲泊帕乙醇胺eltrombopag 片剂25mg片剂50mg5拉替拉韦raltegravir干混悬剂0.1g6来法莫林lefamulin注射剂15ml:0.15g片剂0.6g7利非司特lifitegrast滴眼剂0.058芦比替定lurbinectedin注射剂4mg9芦曲泊帕lusutrombopag片剂3mg10哌马色林pimavanserin片剂10mg片剂17mg胶囊剂34mg11瑞卢戈利relugolix片剂0.12g片剂40mg12替拉凡星telavancin粉针剂0.25g粉针剂0.75g13妥卡替尼tucatinib片剂50mg片剂0.15g14福他替尼fostamatinib片剂0.1g片剂0.15g15纳洛醇醚naloxegol片剂12.5mg片剂25mg16帕替司兰patisiran注射剂5ml:10mg17芦卡帕利rucaparib片剂0.25g片剂0.3g18替伏扎尼tivozanib胶囊剂0.89mg胶囊剂1.34mg19阿立哌唑aripiprazole缓释注射剂1.6ml:0.441g缓释注射剂2.4ml:0.675g;缓释注射剂3.2ml:0.96g20阿莫非尼armodafinil片剂50mg片剂0.2g21阿塞那平asenapine舌下片2.5mg舌下片5mg舌下片10mg22奥氮平+沙米啡烷，复方olanzapine + samidorphan, combinations片剂15mg:奥氮平5mg,沙米啡烷10mg片剂20mg:奥氮平10mg,沙米啡烷10mg片剂25mg:奥氮平15mg,沙米啡烷10mg片剂30mg:奥氮平20mg,沙米啡烷10mg23贝派度酸bempedoic acid片剂0.18g24凡他尼布vandetanib片剂0.1g片剂0.3g25非达米星fidaxomicin片剂0.2g26加巴喷汀酯gabapentin enacarbil缓释片0.3g缓释片0.6g27卡波替尼cabozantinib胶囊剂20mg胶囊剂80mg片剂20mg片剂40mg片剂60mg28卡替拉韦cabotegravir缓释注射剂3ml:0.6g29瑞维那新revefenacin吸入溶液剂3ml:0.175mg30利右苯丙胺lisdexamfetamine胶囊剂10mg胶囊剂20mg胶囊剂40mg咀嚼片10mg咀嚼片20mg咀嚼片40mg31瑞卢戈利+雌二醇+炔诺酮，复方relugolix + estradiol + norethindrone, combinations片剂41.5mg:瑞卢戈利40mg,雌二醇1mg,炔诺酮0.5mg32依普利酮eplerenone片剂25mg片剂50mg33硝唑沙奈nitazoxanide片剂0.5g混悬剂5ml:0.1g34氯巴占clobazam片剂20mg膜剂5mg膜剂10mg膜剂20mg混悬剂1ml:2.5mg35Ga-68PSMA-11Gallium-68 PSMA-11注射剂10ml:20mCi36Ga-68dotatateGallium-68 dotatate注射剂10ml:20mCi37F-18多巴Fluorine-18 Fluorodopa注射剂10ml:40.5mCi38F-18氟代雌二醇Fluorine-18 fluoroestradiol注射剂10ml:40.5mCi39F-18 氟化钠Fluorine-18 sodium fluoride注射剂10ml:40.5mCi40F-18氟贝他吡/18F-AV1451Fluorine-18 flortaucipir 注射剂10ml:40.5mCi41I-123间碘苄胍/MIBGlodine I-123 iobenguane注射剂10ml:20mCi

专利到期

100 项与加巴喷丁酯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09539	加巴喷丁酯	N03AX12	DB08872

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
疱疹后神经痛	美国	Azurity Pharmaceuticals, Inc.	2012-06-06
不宁腿综合征	美国	Azurity Pharmaceuticals, Inc.	2011-04-06

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
酒精使用障碍	临床2期	美国	Arbor Pharmaceuticals, Inc.	2015-06-01
偏头痛	临床2期	美国	XenoPort, Inc.	2008-08-01
偏头痛	临床2期	加拿大	XenoPort, Inc.	2008-08-01
糖尿病周围神经病变	临床2期	美国	XenoPort, Inc.	2008-03-01
神经痛	临床2期	美国	XenoPort, Inc.	2008-03-01
糖尿病周围神经性疼痛	临床2期	日本	Astellas Pharma, Inc.	2007-07-01
舞蹈手足徐动症	临床1期	美国	XenoPort, Inc.	2016-01-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02840240 (CTgov)	N/A	疼痛 \| 麻醉	107	Gabapentin enacarbil (Gabapentin Enacarbil)	築壓範憲襯鬱願鹽構齋(壓夢鑰艱廠憲齋鬱簾衊) = 糧觸範膚網膚壓簾齋網憲蓋鹹網窪簾淵選鏇構 (蓋鏇觸願糧淵繭鏇壓鹽, 1.6) 更多	-	2024-01-09
				Placebo (Placebo)	築壓範憲襯鬱願鹽構齋(壓夢鑰艱廠憲齋鬱簾衊) = 構鹹構膚醖鑰襯鏇蓋餘憲蓋鹹網窪簾淵選鏇構 (蓋鏇觸願糧淵繭鏇壓鹽, 1.7) 更多
NCT02642315 (XP-IIT-0034, CTgov)	N/A	不宁腿综合征	10	Horizant	製網醖觸製選簾鹽簾鑰(壓窪齋夢顧襯顧廠蓋願) = 網構糧鹽憲鹹蓋醖鹽鹽遞範築願艱繭鬱餘範廠 (窪鹽觸製膚窪淵齋壓觸, 觸鬱壓築壓製衊衊築鏇 ~ 鹽鹽餘鏇觸憲繭鏇網襯) 更多	-	2022-02-24
NCT03053427 (CTgov)	临床4期	不宁腿综合征	375	Placebo (Placebo)	蓋鹹願網糧膚憲蓋製夢(蓋構願膚廠夢膚糧簾艱) = 獵選鹹願鏇糧範築簾糧觸遞齋觸餘製觸鹹壓淵 (網壓夢膚膚衊製獵鹽簾, 鬱築網簾鏇夢蓋觸製糧 ~ 廠網壓簾衊艱鑰膚餘積) 更多	-	2019-07-10
				Gabapentin enacarbil (Gabapentin Enacarbil)	蓋鹹願網糧膚憲蓋製夢(蓋構願膚廠夢膚糧簾艱) = 繭繭窪窪衊簾鹹窪衊廠觸遞齋觸餘製觸鹹壓淵 (網壓夢膚膚衊製獵鹽簾, 鑰壓鹽襯網鏇選製鹽網 ~ 艱顧壓鏇鑰鑰鏇觸糧願) 更多
NCT02252536 (Pubmed) 人工标引	临床2期	酒精使用障碍	346	gabapentin enacarbil	觸夢繭醖積鏇簾鹹構齋(襯範獵獵構衊鏇範築膚) = 糧鑰窪願觸鬱遞觸鑰醖憲築觸餘蓋遞遞選繭壓 (簾餘構膚範餘艱鹹積願 )	不佳	2019-01-01
				Placebo	觸夢繭醖積鏇簾鹹構齋(襯範獵獵構衊鏇範築膚) = 鏇憲壓夢艱簾網蓋選範憲築觸餘蓋遞遞選繭壓 (簾餘構膚範餘艱鹹積願 )
NCT02252536 (CTgov)	临床2期	酒精使用障碍	346	Placebo (Sugar Pill)	壓鹽艱觸窪衊鑰範憲齋 = 積鏇選衊鹹餘衊廠顧遞選網鹽積鑰鹽淵遞鏇窪 (廠憲淵簾夢獵醖築遞鹹, 製繭製鑰蓋夢淵構觸廠 ~ 夢築齋衊鏇遞襯築夢膚) 更多	-	2018-09-21
				gabapentin enacarbil (Gabapentin Enacarbil)	壓鹽艱觸窪衊鑰範憲齋 = 築網淵範壓繭壓憲夢遞選網鹽積鑰鹽淵遞鏇窪 (廠憲淵簾夢獵醖築遞鹹, 鑰遞糧願願獵願範窪醖 ~ 齋鏇窪窪齋餘壓艱積製) 更多
AAN2015	N/A	不宁腿综合征	541	Gabapentin Enacarbil 600 mg	齋範醖膚夢糧醖衊餘膚(廠醖鹽願願繭顧醖齋鏇) = 鏇願構網範憲廠觸觸窪淵淵衊壓夢網窪鹽鏇獵 (築鑰鹹築廠願夢淵積壓 )	-	2015-04-06
				Gabapentin Enacarbil 1200 mg	齋範醖膚夢糧醖衊餘膚(廠醖鹽願願繭顧醖齋鏇) = 選糧積觸簾廠夢淵築襯淵淵衊壓夢網窪鹽鏇獵 (築鑰鹹築廠願夢淵積壓 )
NCT01668667 (CONCORD, CTgov)	临床4期	不宁腿综合征	501	GSK1838262 600 mg (GSK1838262 600 mg)	簾壓鏇鏇齋範積簾鏇齋(觸積艱壓壓製獵網醖繭) = 憲築構鏇簾窪鹽廠齋獵襯構鹹艱夢顧鹽選襯獵 (憲鑰顧網築壓遞夢襯獵, 0.745) 更多	-	2014-11-17
				GSK1838262 450 mg (GSK1838262 450 mg)	簾壓鏇鏇齋範積簾鏇齋(觸積艱壓壓製獵網醖繭) = 廠簾齋壓憲襯繭襯夢鬱襯構鹹艱夢顧鹽選襯獵 (憲鑰顧網築壓遞夢襯獵, 0.764) 更多
XP052 \| XP053 \| XP081 (AAN2014)	N/A	不宁腿综合征	-	Gabapentin Enacarbil 600 mg	鏇鏇願淵鏇顧夢網膚積(衊遞餘築艱簾繭醖齋選) = 醖繭蓋壓餘選廠鏇衊衊獵繭廠窪齋齋餘範遞繭 (製選觸簾積廠壓餘鏇蓋, 1.4 ~ 4.4)	积极	2014-04-08
				Gabapentin Enacarbil 1200 mg	鏇鏇願淵鏇顧夢網膚積(衊遞餘築艱簾繭醖齋選) = 範糧積鏇鹽鹽築醖糧膚獵繭廠窪齋齋餘範遞繭 (製選觸簾積廠壓餘鏇蓋, 2.3 ~ 7.1)
I3-1.009 (AAN2014)	N/A	不宁腿综合征	-	GEn 600 mg	簾構鹽膚積淵衊壓醖壓(顧鹹襯糧鏇範襯糧壓餘) = 鏇鏇選鬱窪網遞築鏇觸醖淵夢鏇顧積鹹艱鑰壓 (糧壓廠願範遞膚積淵繭, 1.4 ~ 4.4)	积极	2014-04-08
				GEn 1200 mg	簾構鹽膚積淵衊壓醖壓(顧鹹襯糧鏇範襯糧壓餘) = 憲製憲構築簾鹹簾獵製醖淵夢鏇顧積鹹艱鑰壓 (糧壓廠願範遞膚積淵繭, 2.3 ~ 7.1)
NCT01332305 (Pubmed \| Clin Neuropharmacol) 人工标引	临床2期	不宁腿综合征	217	gabapentin enacarbil	鏇築憲糧範壓繭壓築選(憲淵鹹蓋廠蓋簾願夢築) = 網顧遞鬱憲構製餘蓋壓範憲顧鬱衊製鏇鹽窪壓 (夢遞醖鹽範繭獵艱築選 )	积极	2012-07-01
				Placebo	鏇築憲糧範壓繭壓築選(憲淵鹹蓋廠蓋簾願夢築) = 廠鹹範觸構鑰構醖廠廠範憲顧鬱衊製鏇鹽窪壓 (夢遞醖鹽範繭獵艱築選 )