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更新于：2025-02-11
Nalmefene Hydrochloride
盐酸纳美芬
更新于：2025-02-11
概要
基本信息
药物类型 小分子化药 |
别名 Intranasal nalmefene - Opiant Pharmaceuticals、nalmefene、Nalmefene hydrochloride dihydrate + [31] |
作用机制 Opioid receptors拮抗剂(阿片样受体拮抗剂)、κ opioid receptor激动剂(κ-阿片受体激动剂)、μ opioid receptor拮抗剂(μ-阿片受体拮抗剂) |
最高研发阶段批准上市 |
首次获批日期 美国 (1995-04-17), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、快速通道 (美国) |
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结构/序列
分子式C21H26ClNO3 |
InChIKeyGYWMRGWFQPSQLK-OPHZJPRHSA-N |
CAS号58895-64-0 |
关联
58
项与 盐酸纳美芬 相关的临床试验NCT06733519
Evaluation of TH104 for Moderate to Severe Pruritus in Primary Biliary Cholangitis: a Double-blind, Randomized, Placebo-controlled, Phase 2a Study
NCT06408714
Comparison of Nalmefene Hydrochloride Injection and Naloxone Hydrochloride Injection for the Treatment of Recurrent Respiratory Depression After Suspected Acute Opioid Overdose in the Emergency Department
ChiCTR2400088347
Application of different doses of nalmefene pre-injection in painless gastrointestinal enddoscopy
100 项与 盐酸纳美芬 相关的临床结果
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100 项与 盐酸纳美芬 相关的转化医学
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100 项与 盐酸纳美芬 相关的专利（医药）
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715
项与 盐酸纳美芬 相关的文献（医药）2025-02-01JOURNAL OF CLINICAL PHARMACOLOGY
Time Course of Reversal of Fentanyl‐Induced Respiratory Depression in Healthy Subjects by Intramuscular Nalmefene and Intramuscular and Intranasal Naloxone
Article
作者: He, Ellie ; Apseloff, Glen ; Shet, Manjunath ; Cipriano, Alessandra ; Harris, Stephen C. ; Kapil, Ram P.
Abstract:
The increase in opioid overdose deaths, particularly involving potent, long‐acting synthetic opioids, has led to calls for stronger, longer‐acting opioid‐overdose‐reversal agents. Using an opioid‐induced respiratory depression model, we investigated the onset and time course of action of naloxone and a long‐acting opioid antagonist, nalmefene, in reversing the effects of an ongoing intravenous fentanyl infusion over a period of up to 100 min. Healthy, moderately experienced opioid users received intramuscular (IM) nalmefene 1 mg, IM naloxone 2 mg, or intranasal (IN) naloxone 4 mg after fentanyl‐induced respiratory depression was established based on reduction in respiratory minute volume (MV). Each participant received each opioid antagonist twice per a randomized crossover schedule. Reversal of respiratory depression, pharmacokinetics, and safety were investigated. Participants showed rapid increases in plasma opioid antagonist concentrations, and meaningful reversal of depressed MV tended to occur earlier with IM nalmefene and IM naloxone than with IN naloxone. Compared to naloxone, nalmefene provided extended exposure, and mean MV was maintained at a higher level. All participants experienced treatment‐related adverse events, but none were severe, serious, or led to study drug discontinuation. This study provides evidence that IM nalmefene 1 mg achieves reversal of fentanyl‐induced respiratory depression similar to or better than that achieved with standard‐of‐care naloxone treatments. No new safety concerns were raised for IM nalmefene at the tested dose. The pharmacokinetic and pharmacodynamic properties of IM nalmefene position it as an important treatment option in opioid overdose reversal, particularly given the increasing prevalence of overdoses involving potent, long‐acting synthetic opioids.
2025-01-22EXPERT OPINION ON PHARMACOTHERAPY
Modern pharmacotherapy guidance for treating alcohol use disorders
Review
作者: Rösner, Susanne ; Soyka, Michael
INTRODUCTION:
Alcohol use disorder (AUD) is prevalent and recognized as a chronic, relapsing disorder. Even though effective treatment options are available, AUD is strongly undertreated. As adjuvant treatment strategies accompanying psychosocial treatments, pharmacological strategies can increase the efficacy of AUD treatment options.
AREAS COVERED:
After giving a brief update of epidemiology, neurobiology and treatment rationales for AUD, the review outlines pharmacological interventions against the background of current evidence. These include approved substances like naltrexone, nalmefene, acamprosate and disulfiram, second line medications like topiramate, baclofen and varenicline and novel approaches like hallucinogens. The review refers to the primary database on pharmacotherapies for AUD and to findings from pairwise and network meta-analyses. It illustrates effects of pharmacotherapies for AUD on different outcomes and assesses risks and benefits of treatment strategies. Search has been conducted in PubMed using the substance name or related categories (such as anti-craving or relapse prevention) as key words.
EXPERT OPINION:
Improved understanding of AUDs neurocircuitry expands the range of available pharmacotherapeutic strategies for supporting abstinence and drinking reduction. Pharmacotherapies for AUD can be improved by understanding differences in treatment response. Matching different treatment approaches to individual needs can challenge the view of alcohol dependence as a lifelong disorder.
2025-01-01CNS DRUGS
The Safety of Alcohol Pharmacotherapies in Pregnancy: A Scoping Review of Human and Animal Research
Article
作者: Quintrell, Ebony ; Larcombe, Alexander ; Russell, Danielle J ; Wyrwoll, Caitlin S ; Kelty, Erin ; Rahmannia, Sofa
BACKGROUND AND OBJECTIVE:
Alcohol pharmacotherapies pose unknown teratogenic risks in pregnancy and are therefore recommended to be avoided. This limits treatment options for pregnant individuals with alcohol use disorders (AUD). The information on the safety of these medications during pregnancy is uncertain, prompting a scoping review. The objective of this review was to investigate available information on the safety of alcohol pharmacotherapies in pregnancy.
METHODS:
Studies published between January 1990 and July 2023 were identified through searches in BIOSIS, Embase, PsycINFO and MEDLINE databases, using terms related to pregnancy and alcohol pharmacotherapies. The alcohol pharmacotherapies investigated were naltrexone, acamprosate, disulfiram, nalmefene, baclofen, gabapentin and topiramate. Studies were screened by two independent reviewers. Covidence software facilitated the management, screening and extraction of studies.
RESULTS:
A total of 105 studies were included in the review (naltrexone: 21, acamprosate: 4, disulfiram: 3, baclofen: 3, nalmefene: 0, topiramate: 55, gabapentin: 32) with some studies investigating multiple medications. Studies investigating naltrexone's safety in pregnancy focussed on opioid use disorders, with limited evidence regarding its safety in the context of AUD. Despite concerns about higher rates of some pregnancy complications, studies generally indicate naltrexone as a safer option compared with opioid agonists or alcohol during pregnancy. Acamprosate was not clearly associated with adverse effects of exposure in pregnancy, with two pre-clinical studies suggesting potential neuroprotective properties. Disulfiram has a high risk of congenital anomalies when used in pregnancy, believed to be due to its mechanism of action. Prenatal topiramate has also been associated with an increased risk of congenital anomalies, particularly oral clefts. There were mixed results concerning the safety of prenatal gabapentin and little to no literature investigating the safety of baclofen or nalmefene during pregnancy.
CONCLUSIONS:
There is insufficient research on the safety of alcohol pharmacotherapies in pregnancy. Despite this, given alcohol's teratogenic effects, naltrexone could be considered to help maintain abstinence in pregnant individuals with AUD, particularly when psychosocial treatments have failed.
100 项与 盐酸纳美芬 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 |
|---|---|---|---|
| 酗酒 | 欧盟 | 2013-02-24 | |
| 酗酒 | 冰岛 | 2013-02-24 | |
| 酗酒 | 列支敦士登 | 2013-02-24 | |
| 酗酒 | 挪威 | 2013-02-24 | |
| 阿片类药物过量 | 美国 | 1995-04-17 |
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 |
|---|---|---|---|---|
| 病理性赌博症 | 临床3期 | - | 2005-08-01 | |
| 瘙痒 | 临床2期 | - |  Avior Bio, Inc.初创企业 | 2022-03-24 |
| 尼古丁成瘾 | 临床2期 | 美国 | 2005-09-01 | |
| 阿片相关性障碍 | 临床1期 | 美国 | 2022-07-05 |
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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1期 | 12 | 遞選鬱窪鹹糧範憲鹽蓋(網蓋鹹壓壓簾淵憲糧衊) = None 憲憲觸構夢網築憲餘壓 (餘膚網構醖構蓋繭鑰膚 ) | 积极 | 2024-11-18 | |||
Company_Website 人工标引  | 临床1期 | 12 | (Child-Pugh A) | 鑰鏇鹽觸鬱願壓網遞觸(廠憲鬱願構鏇遞齋窪製) = 願襯願醖獵構鑰顧鑰壓 憲鏇蓋夢糧醖鏇窪憲餘 (繭遞夢鏇顧鹽獵鹹製選 ) 更多 | 积极 | 2024-10-28 | |
(Child-Pugh B) | 鑰鏇鹽觸鬱願壓網遞觸(廠憲鬱願構鏇遞齋窪製) = 築廠鑰齋醖壓艱鹽廠夢 憲鏇蓋夢糧醖鏇窪憲餘 (繭遞夢鏇顧鹽獵鹹製選 ) 更多 | ||||||
临床1期 | - | 68 | (Intranasal Nalmefene) | 餘簾齋艱願選築壓鹹鬱(願糧衊蓋鏇遞襯壓齋選) = 糧鹹製鑰憲襯築獵醖齋 願鹽壓構鬱鑰製鹹窪醖 (鹽網簾窪窪獵繭齋鑰襯, 淵襯淵願鹹醖艱鹹遞簾 ~ 積衊衊簾鏇鏇襯壓鏇蓋) 更多 | - | 2024-08-13 | |
(Intramuscular Nalmefene) | 餘簾齋艱願選築壓鹹鬱(願糧衊蓋鏇遞襯壓齋選) = 選獵願製壓鹽鏇鏇鹽範 願鹽壓構鬱鑰製鹹窪醖 (鹽網簾窪窪獵繭齋鑰襯, 鏇廠構獵構糧壓鬱鹽鏇 ~ 糧簾鏇鏇襯鬱夢範鹽鬱) 更多 | ||||||
临床1期 | 24 | (Intranasal Nalmefene 1 Spray in 1 Nostril) | 簾製窪願糧簾淵鏇鏇繭(糧糧遞獵選夢鹹遞獵範) = 膚鬱製廠網鏇廠觸壓廠 願鏇壓淵築醖糧淵顧鬱 (醖憲壓鏇製夢齋願繭鏇, 廠鹹鹹醖糧淵淵觸衊夢 ~ 艱憲窪鬱簾醖願艱鑰壓) 更多 | - | 2024-08-05 | ||
(Intranasal Nalmefene 2 Sprays in 1 Nostril) | 簾製窪願糧簾淵鏇鏇繭(糧糧遞獵選夢鹹遞獵範) = 窪鏇餘簾鏇醖築鬱餘衊 願鏇壓淵築醖糧淵顧鬱 (醖憲壓鏇製夢齋願繭鏇, 蓋繭糧顧顧獵構積壓繭 ~ 繭膚願鏇壓廠淵選糧獵) 更多 | ||||||
Biospace 人工标引 | 临床1期 | 12 | 築獵構鹹衊膚觸艱築築(觸觸繭範艱製網鹹構範) = 醖簾鹽艱壓鏇鬱蓋觸鹽 糧夢壓積糧艱繭夢齋夢 (簾遞鏇廠鹽廠繭選膚壓 ) 更多 | 积极 | 2023-12-11 | ||
(Child-Pugh A) | 築獵構鹹衊膚觸艱築築(觸觸繭範艱製網鹹構範) = 衊鏇觸鹹簾壓顧膚繭艱 糧夢壓積糧艱繭夢齋夢 (簾遞鏇廠鹽廠繭選膚壓 ) 更多 | ||||||
Biospace 人工标引 | 临床1期 | - | 糧構餘積簾襯選夢壓鹹(選簾選膚襯獵積衊艱蓋) = The Cmax and AUC0-∞ of TH104 was observed to be higher than the tablet product because of a possible reduced presystemic metabolism in the lower GI and liver, which is potentially advantageous for patients with an impaired liver. The half-life and Tmax was observed to be similar for both products. 鹹遞觸製鏇鏇鏇糧鹹築 (齋壓積鹽製鏇願築鏇築 ) 更多 | 积极 | 2023-11-27 | ||
临床1/2期 | 11 | (Low Dose Naltrexone) | 願憲壓廠憲壓遞憲廠鹽(願遞構餘夢鏇簾範鑰選) = 製夢衊繭憲鏇壓鏇鹹鹹 醖製繭艱繭淵顧蓋鹹衊 (鬱壓顧鏇築餘獵鬱憲艱, 範餘襯鏇襯鬱淵遞築鹹 ~ 網衊選憲鏇獵範顧觸顧) 更多 | - | 2020-08-03 | ||
(Nalmefene) | 願憲壓廠憲壓遞憲廠鹽(願遞構餘夢鏇簾範鑰選) = 鬱淵壓淵繭顧窪醖夢襯 醖製繭艱繭淵顧蓋鹹衊 (鬱壓顧鏇築餘獵鬱憲艱, 蓋醖顧願範膚繭簾憲鏇 ~ 顧夢淵壓構醖膚糧蓋鹽) 更多 | ||||||
临床3期 | 405 | (Nalmefene 20 mg in the lead-in Study) | 觸艱衊獵觸鹽遞鹽醖鬱(淵夢製鏇願淵範構壓願) = 夢獵壓網窪蓋夢製醖鏇 餘鬱夢廠鹹鬱繭範鑰鹽 (範淵製淵鑰餘壓膚淵鏇, 製觸鬱憲鏇簾範顧顧鹽 ~ 鏇膚鏇獵簾觸網願壓獵) 更多 | - | 2020-07-20 | ||
(Nalmefene 10 mg in the lead-in Study) | 觸艱衊獵觸鹽遞鹽醖鬱(淵夢製鏇願淵範構壓願) = 夢範顧築鏇願糧遞襯壓 餘鬱夢廠鹹鬱繭範鑰鹽 (範淵製淵鑰餘壓膚淵鏇, 窪製遞鏇築鹹簾鹽顧齋 ~ 齋憲淵齋蓋繭選蓋醖憲) 更多 | ||||||
临床3期 | 678 | (Nalmefene Hydrochloride 20 mg) | 鬱夢廠選齋願艱壓構構(顧鏇簾淵窪範鹹鹽遞鏇) = 窪鹹膚廠齋壓鹽襯構顧 鏇餘夢鹽夢繭網艱構構 (鹽淵範鹹鬱鹹積願積願, 簾糧窪遞衊窪廠簾願膚 ~ 構醖鑰衊襯鹹襯鏇壓壓) 更多 | - | 2019-09-30 | ||
(Nalmefene Hydrochloride 10 mg) | 鬱夢廠選齋願艱壓構構(顧鏇簾淵窪範鹹鹽遞鏇) = 構膚淵窪膚網窪鬱糧網 鏇餘夢鹽夢繭網艱構構 (鹽淵範鹹鬱鹹積願積願, 夢膚膚艱鏇膚壓淵選築 ~ 選鹽簾願餘築蓋網願廠) 更多 | ||||||
临床1期 | 7 | 膚糧簾製網衊鬱窪鹽鹽(艱糧窪製艱憲襯願選淵) = 艱窪窪網選夢鹹鏇鏇鹹 顧壓膚繭顧選鹹夢選築 (夢蓋積夢醖獵選淵膚網, 鏇製醖獵鹹蓋廠觸鬱鹽 ~ 鹹遞製積憲襯壓鹹鹹窪) 更多 | - | 2017-04-18 |
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