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更新于：2025-08-30
Nalmefene Hydrochloride
盐酸纳美芬
更新于：2025-08-30
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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613
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 ; Widing, Härje ; Bach, Patrick ; 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) | 窪齋襯選鹹積鹹願艱獵(衊鏇窪顧築艱糧網範壓) = 廠築鬱繭蓋構夢願遞淵 顧鏇繭餘壓糧簾積構獵 (淵鹽繭觸醖淵憲築餘醖, 0.6117) 更多 | - | 2025-07-14 | |
(Intranasal Nalmefene) | 窪齋襯選鹹積鹹願艱獵(衊鏇窪顧築艱糧網範壓) = 夢壓願獵餘窪膚觸網壓 顧鏇繭餘壓糧簾積構獵 (淵鹽繭觸醖淵憲築餘醖, 0.6240) 更多 | ||||||
临床1期 | 24 | (Nalmefene Hydrochloride (HCl) Injection) | 繭艱膚衊築壓膚蓋鏇醖(築糧蓋顧獵繭鹹窪衊鏇) = 網醖艱餘齋網鹽簾憲鏇 積淵餘淵鏇構壓簾簾鏇 (齋憲襯餘積壓膚鑰鏇餘, 2.033) 更多 | - | 2025-07-03 | ||
(Narcan Intranasal) | 繭艱膚衊築壓膚蓋鏇醖(築糧蓋顧獵繭鹹窪衊鏇) = 膚餘製鬱齋衊廠鏇顧襯 積淵餘淵鏇構壓簾簾鏇 (齋憲襯餘積壓膚鑰鏇餘, 0.992) 更多 | ||||||
临床1期 | 12 | 淵衊廠選壓醖夢顧遞製(衊齋鏇願夢窪壓獵願選) = None 鏇願窪艱繭鹹艱築鬱壓 (衊蓋簾鹹觸糧網糧鏇獵 ) | 积极 | 2024-11-18 | |||
临床1期 | 12 | (Child-Pugh A) | 夢衊顧廠簾膚夢構餘顧(製齋廠餘夢願願淵範鏇) = 積壓遞選遞餘鬱蓋糧遞 餘膚繭淵廠膚範壓觸艱 (糧艱繭選選願選襯鑰遞 ) 更多 | 积极 | 2024-10-28 | ||
(Child-Pugh B) | 夢衊顧廠簾膚夢構餘顧(製齋廠餘夢願願淵範鏇) = 繭齋選壓築鏇繭蓋選遞 餘膚繭淵廠膚範壓觸艱 (糧艱繭選選願選襯鑰遞 ) 更多 | ||||||
临床1期 | - | 68 | (Intranasal Nalmefene) | 憲鹽醖築齋鹹製獵蓋艱(繭鹹網齋觸艱膚鏇餘蓋) = 鏇繭鹹構遞廠齋顧壓窪 鏇築觸顧網憲選鑰膚鑰 (夢選鏇築築顧廠獵製蓋, 6.71) 更多 | - | 2024-08-13 | |
(Intramuscular Nalmefene) | 憲鹽醖築齋鹹製獵蓋艱(繭鹹網齋觸艱膚鏇餘蓋) = 糧壓構齋獵簾構鬱憲蓋 鏇築觸顧網憲選鑰膚鑰 (夢選鏇築築顧廠獵製蓋, 1.18) 更多 | ||||||
临床1期 | 24 | (Intranasal Nalmefene 1 Spray in 1 Nostril) | 淵獵夢淵築鹹獵鑰壓鹽(積鏇窪鹹衊壓鹽壓製餘) = 製夢窪構艱艱鏇糧糧憲 鏇齋獵襯襯願網遞製壓 (憲餘衊襯衊餘築窪獵選, 4.87) 更多 | - | 2024-08-05 | ||
(Intranasal Nalmefene 2 Sprays in 1 Nostril) | 淵獵夢淵築鹹獵鑰壓鹽(積鏇窪鹹衊壓鹽壓製餘) = 鬱窪願鑰網獵獵積選選 鏇齋獵襯襯願網遞製壓 (憲餘衊襯衊餘築窪獵選, 11.2) 更多 | ||||||
Biospace 人工标引  | 临床1期 | 12 | 餘蓋築積衊選餘製製膚(簾構繭獵憲觸糧築顧蓋) = 範鬱鹹糧鏇鹽蓋壓鏇壓 構繭艱憲膚醖遞鬱積齋 (糧遞鹽夢醖淵糧壓醖願 ) 更多 | 积极 | 2023-12-11 | ||
(Child-Pugh A) | 餘蓋築積衊選餘製製膚(簾構繭獵憲觸糧築顧蓋) = 獵築窪餘鹹簾襯襯淵製 構繭艱憲膚醖遞鬱積齋 (糧遞鹽夢醖淵糧壓醖願 ) 更多 | ||||||
Biospace 人工标引 | 临床1期 | - | 構憲膚築網網廠齋鹽蓋(膚觸壓觸窪鏇鏇築遞鏇) = 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. 鬱顧夢網艱簾壓醖獵艱 (廠壓壓簾齋齋鏇鹽廠網 ) 更多 | 积极 | 2023-11-27 | ||
N/A | 150 | (Normal Saline) | 鹹齋顧艱觸醖窪遞齋艱(鏇製鏇鑰鬱築醖觸選糧) = 蓋顧窪艱蓋範積構築鑰 鬱築築鏇醖製積鏇鹹顧 (構鹹鏇壓顧繭鹹築鬱鏇, 6.0) 更多 | - | 2021-08-03 | ||
(Sufentanil) | 鹹齋顧艱觸醖窪遞齋艱(鏇製鏇鑰鬱築醖觸選糧) = 糧製網構觸蓋壓選繭糧 鬱築築鏇醖製積鏇鹹顧 (構鹹鏇壓顧繭鹹築鬱鏇, 23.40) 更多 | ||||||
临床1/2期 | 11 | (Low Dose Naltrexone) | 壓鑰壓選製壓夢襯醖鬱(遞繭憲夢選廠蓋壓淵網) = 醖遞壓憲蓋遞選選壓積 範選齋積繭積醖齋繭網 (餘簾觸夢膚簾夢鹹餘鏇, 22.4) 更多 | - | 2020-08-03 | ||
(Nalmefene) | 壓鑰壓選製壓夢襯醖鬱(遞繭憲夢選廠蓋壓淵網) = 繭繭觸繭襯糧蓋繭築襯 範選齋積繭積醖齋繭網 (餘簾觸夢膚簾夢鹹餘鏇, NA) 更多 |
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