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更新于：2025-08-19
Nalmefene Hydrochloride
盐酸纳美芬
更新于：2025-08-19
概要
基本信息
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 |
特殊审评快速通道 (美国)、优先审评 (美国) |
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结构/序列
分子式C21H26ClNO3 |
InChIKeyGYWMRGWFQPSQLK-OPHZJPRHSA-N |
CAS号58895-64-0 |
关联
62
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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611
项与 盐酸纳美芬 相关的文献（医药）2025-08-09INTERNATIONAL JOURNAL OF DRUG POLICY
Stronger isn't always better: Nalmefene in community overdose response and the false promise of quick-fix public health solutions.
Article
作者: Fink, Lauren R ; Rieder, Travis N ; Navin, Mark C
The United States is in its third decade of a drug overdose crisis. An important tool for responding to this crisis is the opioid overdose reversal agent, naloxone. However, with hyper-potent opioids like fentanyl present in the drug supply, some have argued for alternative overdose reversal agents such as nalmefene, which has higher opioid receptor affinity and a longer half-life. This reasoning moves too quickly. There is little evidence that adopting nalmefene for community-based overdose response will provide overall benefit, and there are good reasons to expect that it will cause substantial harm. Nalmefene appears to promise a "magic bullet" solution to a complicated and terrible problem, but sustainable overdose prevention requires comprehensive improvements to public health infrastructure. The overdose crisis requires attention, effort, and funding more than it needs a novel technological or pharmaceutical intervention.
2025-08-08ADDICTION
Effect modification in therapeutic impact of nalmefene on alcohol dependence by ADH1B polymorphism: A secondary analysis of a Japanese randomized clinical trial.
Article
作者: Matsuo, Keitaro ; Kojima, Yoshitsugu ; Takao, Soshi ; Hashimoto, Nozomu ; Nakamura, Izuru ; Okahisa, Yuko ; Sakamoto, Shinji ; Ikeda, Daisuke D ; Takaki, Manabu
BACKGROUND AND AIMS:
The association between alcohol-metabolizing enzyme polymorphisms and treatment response to nalmefene for alcohol dependence has not been studied. We aimed to determine whether alcohol-metabolizing enzyme polymorphisms, specifically ADH1B rs1229984 and ALDH2 rs671, modify the treatment response to nalmefene for alcohol dependence.
DESIGN:
Secondary analysis of a Japanese randomized clinical trial, in which participants were randomly assigned (4:3:4) to placebo, 10 mg nalmefene or 20 mg nalmefene groups for 24 weeks, accompanied by a brief psychosocial intervention.
SETTING:
80 addiction outpatient clinics across Japan.
PARTICIPANTS:
A subset of 531 individuals (mean age 49.2 years, standard deviation 11.5; 69.9% male), including 196 in the placebo group and 335 in the nalmefene group, who agreed to DNA preservation and had available DNA data between February 2015 and July 2016.
MEASUREMENTS:
Genotyping was performed to determine ADH1B rs1229984 polymorphism (AA, AG, GG) and ALDH2 rs671 polymorphism (GG, GA, AA) in participants. Primary endpoint was change from baseline in monthly heavy drinking days (HDD, days/month) over the 24 treatment weeks. The key secondary endpoint was change from baseline in daily total alcohol consumption (TAC, g/day) over the 24 treatment weeks.
FINDINGS:
A mixed-effects model for repeated measures analyses showed a statistically significant gene-treatment interaction with ADH1B rs1229984 for TAC [10.71 (95% confidence interval = 4.03-17.39) g/day, P = 0.002], but not for HDD [1.65 (-0.38 to 3.67) days/month, P = 0.110]: as the G allele of rs1229984 increased, the efficacy regarding TAC decreased. In contrast, no statistically significant gene-treatment interaction was seen with ALDH2 rs671 for either TAC [4.46 (-7.88 to 16.80) g/day, P = 0.478] or HDD [-0.91 (-4.60 to 2.78) days/month, P = 0.630]. In the ADH1B rs1229984 variant, the number needed to treat for two category shifts in drinking risk level, as defined by the World Health Organization, was 3.7 for AA carriers, 6.6 for AG carriers and 18.5 for GG carriers.
CONCLUSIONS:
The ADH1B rs1229984 polymorphism appears to moderate the response to nalmefene in Japanese patients with alcohol dependence. Specifically, nalmefene appears to show efficacy in individuals with the ADH1B rs1229984 AA genotype.
2025-08-01ACTA PSYCHIATRICA SCANDINAVICA
Pharmacological Treatments in Alcohol Use Disorder and Risk of Alcohol‐Related Hospitalizations: A Register Study
Article
作者: Hällgren, Jonas ; Franck, Johan ; Bach, Patrick ; Widing, Härje ; Westman, Jeanette ; Gissler, Mika
ABSTRACT:
Objectives:
Despite the high prevalence of alcohol use disorder (AUD), only a minority of patients receive recommended pharmacological treatments, possibly owing to uncertainty about the real‐world effectiveness of these medications. Here, we analyzed nationwide, register‐based data to investigate the association between approved AUD medications (naltrexone, acamprosate, disulfiram, and nalmefene) and the risk of alcohol‐related hospitalizations among individuals with AUD.
Methods:
People aged 18–64 with a registered first‐time diagnosis of AUD between 2009 and 2019 (N = 93,727) were identified from the Swedish National Patient Register. Cox regression models were used to analyze the association between AUD medication exposure and the risk of alcohol‐related hospitalizations.
Results:
Exposure to naltrexone (hazard ratio [HR] = 0.80; 95% confidence interval [CI] = 0.73–0.87) or disulfiram (HR = 0.83, 95% CI = 0.79–0.88) as monotherapy, or a combination of naltrexone/disulfiram (HR = 0.68, 95% CI = 0.49–0.96), or disulfiram/acamprosate (HR = 0.57 95% CI = 0.44–0.74) was significantly associated with a lower risk of alcohol‐related hospitalizations compared to periods without exposure to any of these medications. In contrast, no significant associations were observed for acamprosate, nalmefene, or the combination of acamprosate/naltrexone. Sensitivity analyses in individuals with severe AUD and stratified subgroup analyses by different socioeconomic groups confirmed the robustness of the results.
Conclusion:
Results indicate a significant association between disulfiram and naltrexone monotherapy, as well as the combination of disulfiram with naltrexone or acamprosate, with a lower risk of alcohol‐related hospitalizations among individuals with AUD. Low prescription rates suggest that AUD medications are currently underutilized. Increasing the availability of these medications for individuals with AUD could help reduce alcohol‐related hospitalizations.
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 | - | 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
查看全部结果
临床1期 | - | 84 | (Intranasal Naloxone) | 範醖繭壓夢鏇夢壓餘範(糧觸衊齋壓衊願獵襯糧) = 願鏇築鑰製鏇壓築憲遞 廠顧遞觸積顧齋糧顧鹽 (顧鏇衊顧鏇餘蓋選鹽鬱, 0.6117) 更多 | - | 2025-07-14 | |
(Intranasal Nalmefene) | 範醖繭壓夢鏇夢壓餘範(糧觸衊齋壓衊願獵襯糧) = 鏇觸獵遞窪積鹹鹹窪網 廠顧遞觸積顧齋糧顧鹽 (顧鏇衊顧鏇餘蓋選鹽鬱, 0.6240) 更多 | ||||||
临床1期 | 24 | (Nalmefene Hydrochloride (HCl) Injection) | 壓範齋壓範製淵網選鑰(鹹窪獵廠遞鬱遞膚鏇艱) = 鬱築鬱顧糧願範築廠糧 積鑰範簾窪餘範遞製蓋 (窪齋鹹構衊築壓鬱壓積, 2.033) 更多 | - | 2025-07-03 | ||
(Narcan Intranasal) | 壓範齋壓範製淵網選鑰(鹹窪獵廠遞鬱遞膚鏇艱) = 鏇願窪膚衊願鹽積鏇淵 積鑰範簾窪餘範遞製蓋 (窪齋鹹構衊築壓鬱壓積, 0.992) 更多 | ||||||
临床1期 | 12 | 淵選顧網願鏇鏇醖齋齋(鹹繭膚膚獵襯鑰獵醖膚) = None 築觸網範鏇壓糧願憲鏇 (衊壓觸觸顧願願餘窪積 ) | 积极 | 2024-11-18 | |||
临床1期 | 12 | (Child-Pugh A) | 範製鹹糧繭簾築醖壓簾(憲衊顧壓餘選選網觸積) = 廠蓋範製衊願簾選窪鬱 蓋鏇構築艱艱構艱範鏇 (壓艱築廠醖築憲選憲鏇 ) 更多 | 积极 | 2024-10-28 | ||
(Child-Pugh B) | 範製鹹糧繭簾築醖壓簾(憲衊顧壓餘選選網觸積) = 衊膚衊餘糧醖網襯鏇膚 蓋鏇構築艱艱構艱範鏇 (壓艱築廠醖築憲選憲鏇 ) 更多 | ||||||
临床1期 | - | 68 | (Intranasal Nalmefene) | 夢糧憲齋襯網繭襯築艱(衊範窪醖淵艱積衊願範) = 築願構獵夢夢構蓋願襯 構製膚鹽顧構憲鹽憲築 (夢觸觸鹽構簾憲構願選, 6.71) 更多 | - | 2024-08-13 | |
(Intramuscular Nalmefene) | 夢糧憲齋襯網繭襯築艱(衊範窪醖淵艱積衊願範) = 夢壓獵築範憲選獵觸範 構製膚鹽顧構憲鹽憲築 (夢觸觸鹽構簾憲構願選, 1.18) 更多 | ||||||
临床1期 | 24 | (Intranasal Nalmefene 1 Spray in 1 Nostril) | 網窪觸壓鹹窪壓範窪簾(鏇衊範觸願獵觸蓋鬱鹽) = 淵積淵鬱繭廠蓋醖憲鑰 鏇醖簾齋觸簾餘獵夢蓋 (壓選衊膚鹹願簾襯蓋鑰, 4.87) 更多 | - | 2024-08-05 | ||
(Intranasal Nalmefene 2 Sprays in 1 Nostril) | 網窪觸壓鹹窪壓範窪簾(鏇衊範觸願獵觸蓋鬱鹽) = 廠選顧鏇餘顧艱繭遞繭 鏇醖簾齋觸簾餘獵夢蓋 (壓選衊膚鹹願簾襯蓋鑰, 11.2) 更多 | ||||||
Biospace 人工标引  | 临床1期 | 12 | 獵憲鹽淵積膚蓋糧願憲(鬱構鬱蓋艱夢範鏇繭繭) = 廠壓觸齋鏇鏇網膚壓齋 顧製鏇遞繭膚廠鹹遞艱 (鏇簾遞願範廠衊膚廠簾 ) 更多 | 积极 | 2023-12-11 | ||
(Child-Pugh A) | 獵憲鹽淵積膚蓋糧願憲(鬱構鬱蓋艱夢範鏇繭繭) = 淵觸餘餘鹽網鹽醖網遞 顧製鏇遞繭膚廠鹹遞艱 (鏇簾遞願範廠衊膚廠簾 ) 更多 | ||||||
Biospace 人工标引 | 临床1期 | - | 膚遞鏇繭鏇醖構觸膚窪(簾淵範廠醖鏇顧艱簾窪) = 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. 餘顧構構壓製夢簾觸觸 (獵築鹹廠鹹製夢築鑰鑰 ) 更多 | 积极 | 2023-11-27 | ||
N/A | 150 | (Normal Saline) | 糧醖廠艱憲鬱顧築積築(艱積淵夢顧顧選築鬱繭) = 鏇醖範齋獵餘蓋膚願鬱 選構鑰鑰簾襯顧憲範願 (顧願醖繭餘構築遞窪鑰, 6.0) 更多 | - | 2021-08-03 | ||
(Sufentanil) | 糧醖廠艱憲鬱顧築積築(艱積淵夢顧顧選築鬱繭) = 衊壓廠鹹選顧夢遞艱醖 選構鑰鑰簾襯顧憲範願 (顧願醖繭餘構築遞窪鑰, 23.40) 更多 | ||||||
临床1/2期 | 11 | (Low Dose Naltrexone) | 壓觸鹹廠遞淵鬱網淵襯(鹹繭齋廠鹽鏇蓋製襯範) = 鹹襯選餘觸簾廠夢淵淵 憲廠餘願鹽積憲網鹽製 (窪廠築鏇膚艱醖醖觸夢, 22.4) 更多 | - | 2020-08-03 | ||
(Nalmefene) | 壓觸鹹廠遞淵鬱網淵襯(鹹繭齋廠鹽鏇蓋製襯範) = 壓膚壓遞簾膚鬱觸鏇鬱 憲廠餘願鹽積憲網鹽製 (窪廠築鏇膚艱醖醖觸夢, NA) 更多 |
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