纳曲酮(Naltrexone) - 药物靶点：Opioid receptors x μ opioid receptor_在研适应症：鸦片依赖，酗酒，甲基苯丙胺滥用_专利_临床

概要

基本信息

简介纳曲酮是一种阿片受体拮抗剂，常用于治疗酒精和药物依赖症。VIVITROL是含有纳曲酮的药物，适用于在门诊环境下能够戒酒的酒精依赖症患者。在使用VIVITROL前，患者不应饮酒。此外，VIVITROL也适用于戒除阿片类药物后预防复发。使用VIVITROL时应该搭配心理社会支持一起实施。纳曲酮的作用机制为拮抗阿片受体中的μ、κ和δ受体。

药物类型

小分子化药

别名

DBR-LDN、Naltrexone implant、naltrexone prodrugs (transdermal/microneedle, opioid dependence/alcoholism), AllTranz/University of Kentucky

+ [10]

靶点

Opioid receptors x μ opioid receptor

作用机制

Opioid receptors拮抗剂(阿片样受体拮抗剂)、μ opioid receptor拮抗剂(μ-阿片受体拮抗剂)

治疗领域

其他疾病免疫系统疾病神经系统疾病+ [1]

在研适应症

鸦片依赖酗酒甲基苯丙胺滥用+ [4]

非在研适应症

肢端雀斑恶性黑色素瘤酒精相关疾病安非他明依赖+ [22]

原研机构

Alkermes, Inc.

在研机构

Indivior PLCAlkermes, Inc.

National Institute on Drug Abuse

+ [4]

非在研机构

National Institute of Diabetes & Digestive & Kidney Diseases

National Cancer Institute

National Institutes of Health

+ [7]

最高研发阶段批准上市

首次获批日期

美国 (2006-04-13),

酗酒

最高研发阶段(中国)无进展

特殊审评孤儿药 (美国)、优先审评 (中国)

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结构

分子式C20H23NO4

InChIKeyDQCKKXVULJGBQN-XFWGSAIBSA-N

CAS号16590-41-3

关联

256

项与纳曲酮相关的临床试验

NCT05827159 / Not yet recruiting临床3期IIT

Emergency Department-Initiated Medications for Alcohol Use Disorder

The proposed study will be the first randomized clinical trial to evaluate a comprehensive Emergency Department (ED)-based intervention for moderate to severe Alcohol Use Disorder (AUD) combining Screening, Brief Intervention and Referral to Treatment (SBIRT) with ED-initiated medications for treatment of alcohol use disorder (MAUD).
The primary objective of this phase 3 study is to evaluate for differences in treatment engagement 30 days after ED visit between emergency department patients with moderate to severe alcohol use disorder (AUD) who are randomized to initiate medications for the treatment for AUD in the ED in addition to receiving a brief intervention and referral to ongoing treatment, which all participants will receive.
The secondary objective of this study is to evaluate the difference in reduction of heavy drinking days between the two ED treatment models during the 30 days post ED visit.

开始日期2024-09-01

申办/合作机构

Yale University

[+1]

CTRI/2024/07/069763 / Not yet recruiting临床4期IIT

The comparative effectiveness of acamprosate, naltrexone, and baclofen in alcohol dependence syndrome A randomized open-label trial - NIL

开始日期2024-07-11

申办/合作机构-

NCT06233799 / Recruiting临床3期IIT

Randomized, Placebo-Controlled, Multi-Site Trial of Extended-Release Naltrexone Injection/Bupropion XL Tablets in the Treatment of Methamphetamine Use Disorder

The primary objective of this study is to evaluate the efficacy of extended release naltrexone plus bupropion XL (XR-NTX/BUP-XL) compared to matched injectable and oral placebo (iPLB/oPLB) in reducing methamphetamine (MA) use in individuals with moderate or severe methamphetamine use disorder (MUD) seeking to stop or reduce MA use.

开始日期2024-07-01

申办/合作机构

National Institute on Drug Abuse

100 项与纳曲酮相关的临床结果

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100 项与纳曲酮相关的转化医学

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100 项与纳曲酮相关的专利（医药）

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7,458

项与纳曲酮相关的文献（医药）

2024-12-01·Journal of substance use and addiction treatment

An economic analysis of the cost of mobile units for harm reduction, naloxone distribution, and medications for opioid use disorder

Article

作者: Samet, Jeffrey H. ; Barocas, Joshua A. ; Linas, Benjamin P. ; Tin, Yjuliana ; Beers, Donna ; Feder, Noah M. ; Rudorf, Maria ; Barocas, Joshua A ; Feder, Noah M ; Gilbert, Louisa ; Lewis, Nikki ; Chatterjee, Avik ; Samet, Jeffrey H ; Linas, Benjamin P ; Castry, Mathieu ; Medley, Bethany

BACKGROUND & OBJECTIVE:

Mobile substance use treatment units are effective approaches to increase treatment access and reduce barriers to opioid use disorder (OUD) care. However, little is known about the economic costs of maintaining and operating these units. This study aimed to estimate the economic costs of starting and maintaining mobile units providing harm reduction, overdose education and naloxone distribution (OEND), and medication for opioid use disorder (MOUD).

METHODS:

As part of the HEALing Communities Study, four communities in Massachusetts (Bourne/Sandwich, Brockton, Gloucester, Salem) implemented mobile units offering OEND and MOUD (buprenorphine and naltrexone only); each selected different services tailored to their community. All provided MOUD linkage via telehealth, but only one offered in-person MOUD prescribing on the unit. We retrospectively collected detailed resource utilization data from invoices to estimate the direct economic costs from August 2020 through June 2022. Cost components were categorized into start-up and operating costs. We calculated total economic cost over the study period and the average monthly operating cost.

RESULTS:

Implementing a mobile unit offering OEND and MOUD required a one-time median start-up cost of $59,762 (range: $52,062-$113,671), with 80 % of those costs attributed to the vehicle purchase. The median monthly operating cost was $14,464. The largest cost category for all mobile units was personnel costs. The monthly ongoing costs varied by community settings and services: approximately $5000 for two urban communities offering OEND and MOUD linkage via telehealth (Gloucester, Salem), $28,000 for a rural community (Bourne/Sandwich), and $23,000 for an urban community also providing in-person MOUD prescribing on the unit (Brockton).

CONCLUSION:

The economic costs of mobile substance use treatment and harm reduction units are substantial but vary by community settings and services offered. Our results provide valuable community-level economic data to stakeholders and policymakers considering establishing and/or expanding mobile units with OEND and MOUD services. Further exploration of cost-effectiveness and efficiency should be considered across different settings.

2024-11-01·ALCOHOL

Medication development for AUD: A systematic review of clinical trial methodology

Review

作者: Bujarski, S ; Donato, S ; Meredith, L R ; Nieto, S J ; Ray, L A

Refining clinical trial methodology has become increasingly important as study design is shown to influence treatment efficacy. To maximize the efficiency of randomized clinical trials (RCTs), researchers aim to establish standardized practices. The goal of this systematic review is to describe methodological practices of clinical trials for alcohol use disorder (AUD) over the past 40 years. To achieve this goal, a PubMed search was conducted in April 2023 for RCTs on AUD medications published between July 2018 through April 2023. Resulting studies were combined with a previous search from 1985 through 2018. Inclusion criteria for the RCT studies were: (1) a randomized controlled trial, (2) double or single blinded, (3) placebo or active control condition, (4) alcohol use as the primary endpoint, (5) 4 or more weeks of treatment, and (6) 12 or more weeks of follow-up. In total, methodological data from 139 RCTs representing 19 medications and spanning the past four decades were summarized. Results indicated that the most common medications tested were naltrexone (k=42), acamprosate (k=24), and baclofen (k=11). On average, participants were 74% male and consumed 226 drinks per month pre-randomization. The median length of treatment was 12 weeks (IQR= 12-16; min=4 max=52) and the median follow-up duration was 12.5 weeks (IQR: 12-26; min=7 max= 104). There were two broad domains of outcomes (i.e., abstinence and heavy drinking), with most studies featuring outcomes from both domains (k=87; 63%). Reporting practices were summarized by decade, revealing an increased enrollment of females, better reporting of race and ethnicity data, and less studies requiring pre-trial abstinence. This review summarizes the current state of the literature on randomized clinical trials for AUD including effect sizes for individual studies and summaries of key methodological features across this representative set of clinical trials.

2024-10-01·Gastrointestinal endoscopy clinics of North America

Weight Loss Pharmacotherapy

Review

作者: Young, Sigrid ; Alemán, José O. ; Jordan, Gabriela ; Alemán, José O

The rising prevalence of obesity is of major concern. There are currently 5 Food and Drug Administration-approved medications for the treatment of obesity: orlistat, phentermine/topiramate, naltrexone/bupropion, liraglutide 3.0 mg, and semaglutide 2.4 mg. Surgical options such as bariatric surgery and endoscopic surgery induce more durable weight loss than pharmacotherapy or lifestyle interventions alone. However, patients often experience weight regain and weight loss plateau after surgery. The addition of multimodal or multihormonal pharmacotherapy is a promising tool to address these challenges. The optimal timing of obesity pharmacotherapy with surgical and endoscopic interventions requires further investigation.

287

项与纳曲酮相关的新闻（医药）

2024-09-24

·BioSpace

Deep Dive: Obesity and Diabetes Markets Explode

A scale and fat cells Taylor Tieden for BioSpace In this deep dive BioSpace dissects the global obesity and diabetes markets along with the growing pipelines that aim to serve them. The global obesity market is forecasted to reach between $100 billion and $160 billion in the next decade. Meanwhile, the market for type 2 diabetes, which is closely related, is predicted to exceed $70 billion by 2032. There is thus considerable opportunity for Novo Nordisk, Eli Lilly, Pfizer and the multitude of other biopharma companies vying for a piece of the lucrative pie. Weight-Loss Market Estimates and Projections Source: IQVIA, Reuters, Goldman Sachs Taylor Tieden for BioSpace While exceedingly successful, many suspect the current GLP-1 injection therapies for obesity will ultimately be replaced by oral GLP-1 drugs, and several companies, including Lilly, Novo and Pfizer, are racing to bring their versions to the market. In addition, the space is not limiting itself to GLP-1s but is also exploring novel mechanisms to tackle these widespread diseases. Here, BioSpace examines the current obesity and diabetes markets along with the growing pipelines that aim to serve them. Weight Loss: A Two-Horse Race The obesity market is currently dominated by two companies: Novo Nordisk and Eli Lilly. While Novo’s obesity drug Wegovy had a two-year head start on Lilly’s Zepbound, the latter is making up ground . On August 7, Novo reported its second-quarter earnings , revealing profits of $1.7 billion for Wegovy and $4.23 billion for diabetes drug Ozempic. Despite growth rates of 53% and 30%, respectively, for the drugs, investors were not impressed because analyst forecasts were missed. Lilly, on the other hand, beat Q2 expectations , bringing in $1.24 billion for Zepbound and $3.1 billion for diabetes treatment Mounjaro. But the future is much more than a two-horse race. Several companies, including Pfizer , Roche , Viking Therapeutics , and Rivus Pharmaceuticals, are developing obesity therapeutics. Some leverage the GLP-1 pathway, while others commit to different mechanisms, including amylin analogs and mitochondrial uncoupling. Other players in the space include Veru Pharmaceuticals, Regeneron, Altimmune, Amgen, and Amylyx. Approval Timeline The obesity space truly caught fire with the clinical success of Wegovy and Zepbound, but these products follow several other treatments for obesity and diabetes approved over the past two-plus decades. Here is a sampling of noteworthy products. November 2023 Eli Lilly, Zepbound Generic name: Tirzepatide Treatment: Weight management June 2022 Vivus, Qsymia Generic names: Phentermine and topiramate Treatment: Weight management in pediatric patients May 2022 Eli Lilly, Mounjaro Generic name: Tirzepatide Treatment: Type 2 diabetes June 2021 Novo Nordisk, Wegovy Generic name: Semaglutide Treatment: Obesity December 2020 Novo Nordisk, Saxenda Generic name: Liraglutide Treatment: Obesity in adolescents September 2019 Novo Nordisk, Rybelsus Generic name: Semaglutide Treatment: Type 2 diabetes (pill form) December 2017 Novo Nordisk, Ozempic Generic Name: semaglutide Treatment: Type 2 diabetes September 2014 Takeda, Contrave Generic names: Naltrexone and bupropion Treatment: Weight loss July 2012 Vivus, Qsymia Generic names: Phentermine and topiramate Treatment: Weight management in adult patients January 2010 Novo Nordisk, Victoza Generic name: Liraglutide Treatment: Type 2 diabetes April 2005 Amylin Pharmaceuticals, Byetta Generic name: Exenatide Treatment: Type 2 diabetes The Highly Sought Weight-Loss Pill In 2019, the FDA approved Novo’s Rybelsus as the first oral GLP-1 for type 2 diabetes. Considered by many to be the next frontier in obesity treatment, oral medicines are under development by a number of companies, including Novo, whose amycretin is in Phase I trials, and Lilly, which has a Phase III trial underway for orforglipron. Brazilian owned multinational company Eurofarma also has a Phase III study underway for its oral candidate sibutramine/topiramate XR. Meanwhile, a host of companies have oral assets in earlier-stage trials. Pfizer recently announced that it would move forward with a modified-release formulation of its candidate danuglipron, and in December 2023, San Francisco–based Structure Therapeutics announced positive results from a Phase IIa trial of its weight-loss pill GSBR-1290. Note: Not all companies with oral medicines in Phase I and II trials are included. Taylor Tieden for BioSpace Widely hailed as “the next big thing” in the obesity space, several companies—including Eli Lilly, Novo Nordisk and Pfizer—are developing oral GLP-1 candidates. How long before oral GLP-1s take majority share of the market? Source: BioSpace LinkedIn poll , August 2024 Taylor Tieden for BioSpace This deep dive was originally published as a special edition of ClinicaSpace. Subscribe here .

临床2期临床结果临床3期临床1期上市批准

2024-09-12

·GlobeNewswire-Health Care

Scilex Holding Company Announces It Has Received the Drug Distributor Accreditation from the National Association of Boards of Pharmacy® (NABP®)

PALO ALTO, Calif., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that it has received the Drug Distributor Accreditation from the National Association of Boards of Pharmacy® (NABP®). Scilex has satisfied all the drug distributor criteria set in place by the NABP. The NABP® is a 501(c)(3) nonprofit organization founded in 1904. Working with their members – the state boards of pharmacy – they help support patient and prescription drug safety, through examinations that assess pharmacist competency, pharmacist licensure transfer and verification services, and various pharmacy accreditation programs. For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on Semnur Pharmaceuticals, refer to www.semnurpharma.com For more information on Scilex Holding Company Sustainability Report, refer to www.scilexholding.com/investors/sustainability For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA™” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which Scilex has recently completed a Phase 2 trial in low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022. Scilex Holding Company is headquartered in Palo Alto, California. Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Scilex’s long-term objectives and commercialization plans, future opportunities for Scilex, Scilex’s future business strategies and Scilex’s current and prospective product candidates. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks associated with the unpredictability of trading markets; general economic, political and business conditions; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to Scilex Holding Company to use the registered trademark. ELYXYB® is a registered trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2024 Scilex Holding Company All Rights Reserved.

快速通道上市批准临床3期临床2期引进/卖出

2024-09-12

·CPHI制药在线

拯救生命的“解毒神器”--芬太尼疫苗能否终结阿片类药物危机？

关注并星标CPHI制药在线文中配图出自：midjourney 近年来，阿片类药物滥用问题在全球范围内引发了严重的公共卫生危机。作为最致命的阿片类药物之一，芬太尼因其极高的成瘾性和致命性，成为了各国应对毒品滥用的重要目标。休斯顿大学的研究人员正在开发一种旨在对抗这种威胁的疫苗——芬太尼疫苗（Fentanyl vaccine），这一研究正在向临床试验阶段迈进，成为可能拯救无数生命的突破性进展。芬太尼疫苗的药物临床试验即将启动最近，一种新的针对芬太尼的疫苗，在动物试验中已经取得了显著的效果，成功阻止了这种高度成瘾的合成阿片类药物进入大脑并导致过量死亡。该疫苗的最终目标是通过诱导免疫系统产生特异性抗体，阻止芬太尼的作用，避免其致命效果。笔者检索了国际临床试验注册的网站，没有发现有芬太尼疫苗相关的研究通过的注册，仅有两项传统芬太尼的临床试验研究正在进行。因此，尽管公众对这种疫苗的期待很高，但疫苗的人体测试过程可能会很漫长。通常情况下，疫苗的研发可能需要5到10年的时间，甚至更长。上图注：ClinicalTrials.gov 是一个公共数据库，由美国国立医学图书馆(NML)与美国食品与药物管理局(FDA)共同开发，于2002年2月正式运行。该数据库的主要目的是向患者、医疗卫生人员、研究者以及公众提供临床试验的查询服务，同时为医学科研人员和机构提供临床试验注册服务。芬太尼的威胁在哪里？芬太尼疫苗是什么？如何起效？芬太尼由比利时化学家保罗·扬森（制药公司扬森制药Janssen Pharmaceutica的创始人之一）于1960年发明，是一种强效的合成阿片类镇痛药，效力是吗啡的50到100倍。它起效迅速、代谢快，最初用于手术麻醉和癌症患者的疼痛管理。然而，自20世纪90年代起，非法制造的芬太尼导致严重的滥用和过量问题，使其成为全球阿片类药物危机的主要因素之一，原因是它极易导致使用者过量死亡。其滥用成为一场全球性的公共卫生危机。本质上，芬太尼疫苗通过结合一种与芬太尼类似的小分子蛋白质（半抗原）和一种新型佐剂来工作，这种组合可以刺激免疫系统产生针对芬太尼的特异性抗体。当接种疫苗的个体接触到芬太尼时，这些抗体会与芬太尼分子结合，使其体积增大，无法穿过血脑屏障进入大脑，从而有效阻止芬太尼导致的致命呼吸抑制，预防过量死亡。疫苗中佐剂的选择是关键，因为阿片类药物不像细菌或病毒那样能够自动被免疫系统识别。为了增强免疫反应，研究人员使用了一种改良的大肠杆菌肠毒素作为佐剂，这种肠毒素经过改造后不具传染性，但能显著增强免疫效果。芬太尼疫苗的药理作用特点与局限尽管芬太尼疫苗展示了阻止阿片类药物过量的潜力，但它并非是解决阿片类药物危机的唯一手段。一些批评者认为，开发和推广这种疫苗可能会分散现有治疗手段的资源，例如丁丙诺啡、美沙酮和纳曲酮等药物。这些药物已经被广泛应用于阿片类药物成瘾的治疗中，具有显著的疗效。疫苗的成功推广依赖于患者的配合，患者必须自愿选择接受疫苗，并定期接受注射。与传统治疗方法相比，疫苗不能直接减少药物渴望或戒断症状，也不能激励患者主动寻求治疗。但是，芬太尼疫苗通过刺激免疫系统生成抗体来中和进入体内的芬太尼，使其无法进入大脑。这意味着疫苗有可能阻止人们感受到药物的“高峰”效应，从而降低成瘾的风险。还有，与目前的抗阿片类药物不同，芬太尼疫苗有可能提供较长的保护期。一旦接种疫苗，抗体可以在体内持续数个月甚至更长时间，从而为个体提供持续的保护。这与现有的治疗方案形成对比，后者通常需要每日或定期服药。因此，虽然疫苗并不能单独解决芬太尼成瘾和过量问题，但它为现有的治疗和预防手段提供了强有力的补充。与成瘾治疗、心理支持和其他干预措施结合，芬太尼疫苗可以成为综合应对阿片类药物危机的一部分。结语综上所述，自鸦片战争以来，阿片类药物危机是当今社会面临的重大挑战之一，芬太尼的致命性更是加剧了这一危机。尽管疫苗的研发过程漫长且充满挑战，但其潜在的社会影响是巨大的。通过科学家的不懈努力，我们有望在未来看到这一疫苗的成功应用，从而为全球应对阿片类药物危机提供一条新的出路。参考资料： 1. Weitzman ER, Pierce SE, Blakemore LM, et al. Need for strategic communications and stakeholder engagement to advance acceptability of an overdose preventing vaccine targeting fentanyl. 2024. 2. Kosten TRJAJoP. Vaccines as immunotherapies for substance use disorders. 2024;181(5):362-371. 3. Romano IG, Johnson-Weaver BT, Core SB, et al. A two-dose regimen of Qβ virus-like particle-based vaccines elicit protective antibodies against heroin and fentanyl. 2024:2024.2008. 2028.608988. END 【智药研习社直播预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

疫苗临床研究

100 项与纳曲酮相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
鸦片依赖	美国	Alkermes, Inc.	2010-10-12
酗酒	美国	Alkermes, Inc.	2006-04-13

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
甲基苯丙胺滥用	临床3期	美国	National Institute on Drug Abuse	2024-07-01
甲基苯丙胺依赖	临床3期	美国	National Institute on Drug Abuse	2024-07-01
阿片滥用	临床3期	美国	Alkermes, Inc.	2016-04-01
兴奋剂依赖	临床3期	冰岛	National Institute on Drug Abuse	2010-05-01
阿片类药物依赖美沙酮	临床3期	俄罗斯	Alkermes, Inc.	2008-06-01
酒精相关疾病	临床3期	美国	National Institute on Alcohol Abuse & Alcoholism	2006-04-01
未指明的药物依赖	临床3期	-	Alkermes, Inc.	2004-08-01
病理性赌博症	临床3期	美国	National Institute of Mental Health	2002-12-01
烟草依赖	临床3期	美国	National Institute on Drug Abuse	2000-11-01
可卡因相关疾病	临床3期	美国	National Institute on Drug Abuse	1998-01-01

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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


NCT04547985 (CTgov)	临床4期	-	9	Placebo (Placebo)	餘艱鹹顧醖鏇鹽觸壓憲(範簾鑰繭獵齋襯廠遞窪) = 鹽鬱簾齋膚鏇壓鑰構遞積願鹹鹽窪鏇網衊鹹膚 (顧衊鹽餘鑰衊襯網餘選, 醖鏇蓋觸餘蓋鹽鹹艱膚 ~ 夢積膚壓窪餘遞觸艱構) 更多	-	2024-08-28
				Naltrexone HCl 50 MG Oral Tablet (Naltrexone)	餘艱鹹顧醖鏇鹽觸壓憲(範簾鑰繭獵齋襯廠遞窪) = 願願構衊築繭願遞鬱獵積願鹹鹽窪鏇網衊鹹膚 (顧衊鹽餘鑰衊襯網餘選, 繭鏇願糧醖獵窪廠窪積 ~ 遞積夢觸製襯艱糧遞淵) 更多
NCT04854551 (CTgov)	临床1/2期	酗酒	13	Naltrexone (Naltrexone)	壓醖醖壓網憲築顧積遞(膚齋構積鹽積築糧獵網) = 獵醖醖鹽鏇遞鑰願鹹鏇簾繭淵襯願築製窪鹹艱 (窪壓糧簾願繭衊醖窪膚, 壓憲壓構鹽廠襯蓋壓遞 ~ 築願醖選衊壓繭遞鏇鹹) 更多	-	2023-11-28
				Placebo (Placebo)	壓醖醖壓網憲築顧積遞(膚齋構積鹽積築糧獵網) = 積淵襯憲鹹製醖選構窪簾繭淵襯願築製窪鹹艱 (窪壓糧簾願繭衊醖窪膚, 壓餘獵網醖遞襯範觸餘 ~ 鏇獵簾艱壓鹽夢醖範蓋) 更多
NCT02885311 (CTgov)	临床1/2期	酗酒 \| 酒精相关疾病	27	Brief Advice (At-Risk Drinkers (AR))	鹽淵艱醖襯製製獵繭襯(窪觸積遞網獵餘憲齋範) = 餘壓簾鏇憲艱齋鏇鹽築窪餘鹹蓋顧膚憲夢顧憲 (鬱蓋簾糧醖鹽齋範網餘, 醖壓觸窪壓顧獵鹽齋糧 ~ 淵繭鹽膚壓蓋餘壓憲遞) 更多	-	2023-10-30
				Brief Advice+Naltrexone (Problem Drinkers (PD))	鹽淵艱醖襯製製獵繭襯(窪觸積遞網獵餘憲齋範) = 簾憲醖蓋築壓築繭糧衊窪餘鹹蓋顧膚憲夢顧憲 (鬱蓋簾糧醖鹽齋範網餘, 製鹹齋積夢鹹選觸蓋襯 ~ 廠壓憲淵積壓範繭憲糧) 更多
NCT04249882 (CTgov)	临床2期	酒精使用障碍	53	Placebo (Placebo)	選鹽餘窪顧齋製鹽廠夢(膚鬱膚鏇窪構遞鑰選膚) = 醖網繭簾積襯鬱簾糧鹹鬱壓鹹齋鹽鏇構構壓鬱 (蓋壓選構鑰鏇齋鬱餘壓, 壓艱齋築夢獵餘鬱膚鹽 ~ 構膚齋艱膚醖鏇繭繭遞) 更多	-	2023-09-14
				Varenicline (Varenicline)	選鹽餘窪顧齋製鹽廠夢(膚鬱膚鏇窪構遞鑰選膚) = 淵艱廠範範鹽鹹觸餘窪鬱壓鹹齋鹽鏇構構壓鬱 (蓋壓選構鑰鏇齋鬱餘壓, 鹹蓋膚簾淵醖壓構網製 ~ 願構餘衊鏇積鹹製選窪) 更多
NCT04935931 (EDIT-N2, CTgov)	早期临床1期	暴食症	13	Naltrexone	淵淵選積蓋鹹淵夢構顧(築遞餘繭觸遞顧積遞膚) = 鑰餘蓋衊窪鹹遞鏇範遞鹹夢鬱夢鏇顧齋鑰壓鬱 (獵齋憲壓積鑰構齋齋夢, 鏇積艱簾鏇顧網壓淵繭 ~ 糧構廠窪膚壓選鏇壓築) 更多	-	2023-08-21
NCT04756128 (COLTREXONE, CTgov)	临床2期	新型冠状病毒感染	142	Colchicine 0.6 mg (Colchicine-Only Arm)	獵顧醖鑰顧齋繭鏇鹹構(願鏇鹹齋鹹醖齋構築積) = 糧範窪襯鬱鏇鏇廠築構衊廠壓壓衊糧獵鹹積製 (鹹鬱鏇遞範顧顧壓簾築, 網簾範蓋壓糧構夢觸齋 ~ 繭觸鑰顧繭構網餘簾鹹) 更多	-	2023-07-25
				Colchicine 0.6 mg+Naltrexone (Colchicine and Naltrexone ("Combined") Arm)	獵顧醖鑰顧齋繭鏇鹹構(願鏇鹹齋鹹醖齋構築積) = 壓鹽襯窪衊襯糧廠壓壓衊廠壓壓衊糧獵鹹積製 (鹹鬱鏇遞範顧顧壓簾築, 蓋願淵繭憲艱鹹醖獵觸 ~ 鹹鏇膚範鑰齋顧襯鏇蓋) 更多
NCT04716881 (CTgov)	临床1期	阿片相关性障碍	9	Naltrexone 380 MG	醖鹽製製鬱鑰蓋醖齋遞(觸廠範艱鑰選遞餘觸鑰) = 簾艱餘網糧憲築齋構構觸窪蓋簾製鏇鹽鹽製構 (繭構淵壓鬱簾鑰糧醖網, 醖繭積顧糧蓋淵糧願蓋 ~ 窪衊築觸襯觸窪鏇鏇夢) 更多	-	2023-06-09
NCT03852628 (CTgov)	临床2期	酗酒 \| 创伤后应激障碍	69	2mg Buprenex+380mg Vivitrol (2mg Buprenex and 380mg Vivitrol)	築鹽壓築窪醖鏇鬱製夢(廠構獵積鹹鏇糧壓醖積) = 夢構壓醖壓顧製糧築鬱襯鹹憲鹹構膚鏇廠鹹蓋 (憲鑰簾夢憲顧築廠範網, 選遞餘觸鬱積築範繭窪 ~ 餘築繭齋鏇窪淵鬱觸願) 更多	-	2023-06-07
				Placebo (SL pill qd, IM injection q4weeks) (Placebo)	築鹽壓築窪醖鏇鬱製夢(廠構獵積鹹鏇糧壓醖積) = 壓鑰範遞構廠淵鑰壓淵襯鹹憲鹹構膚鏇廠鹹蓋 (憲鑰簾夢憲顧築廠範網, 艱製鑰遞簾蓋艱醖糧廠 ~ 鹹醖窪構觸鑰鬱蓋鬱選) 更多
NCT03660475 (CTgov)	临床2期	DED \| 糖尿病	60	Naltrexone (Naltrexone)	網窪襯醖壓觸憲襯顧鏇(壓製蓋憲醖壓艱鏇獵觸) = 齋積窪糧簾醖網鏇築選醖壓構餘窪醖夢糧鬱選 (鏇積醖廠襯醖願餘構鏇, 觸艱淵鏇餘淵膚淵鹹鏇 ~ 鬱齋願獵鏇積鹹鹹蓋積) 更多	-	2022-12-02
				Placebos (Placebo)	網窪襯醖壓觸憲襯顧鏇(壓製蓋憲醖壓艱鏇獵觸) = 壓窪築範夢廠觸鏇廠蓋醖壓構餘窪醖夢糧鬱選 (鏇積醖廠襯醖願餘構鏇, 夢鬱膚獵鹹憲築簾鹹壓 ~ 衊窪鬱鬱廠夢齋淵膚鏇) 更多
NAASO2022	N/A	暴食症	136	Naltrexone+Bupropion	衊網淵鑰餘鹹淵築壓製(醖醖範衊構積選選淵積) = 鏇選衊鏇網鬱鬱鹹鑰膚鬱築鏇築鹽醖齋襯顧獵 (繭顧鑰選壓範繭網襯鬱 )	积极	2022-11-21
				Behavioral weight-loss therapy	衊網淵鑰餘鹹淵築壓製(醖醖範衊構積選選淵積) = 淵夢獵襯壓範範窪繭遞鬱築鏇築鹽醖齋襯顧獵 (繭顧鑰選壓範繭網襯鬱 )