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更新于：2025-09-10
Nalmefene Hydrochloride
盐酸纳美芬
更新于：2025-09-10
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
65
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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614
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.
2025-08-01VACCINE
Pre-clinical characterization of virus-like particles as a platform for nanovaccines against heroin and oxycodone
Article
作者: Hamid, Fatima A ; Hannon, Bryan ; Marecki, Courtney ; Seaman, Robert W ; Tronconi, Davide ; Pravetoni, Marco ; Kim, Caroline M
Opioid use disorder (OUD) and drug-related overdoses continue to pose a major public health challenge in the United States, Canada, Europe and other countries worldwide. While effective treatments for OUD such as methadone, buprenorphine, and naltrexone, as well as overdose reversal medications such as naloxone and nalmefene, are available, access to medication assisted treatments (MATs) remains limited. This underscores the need for the development and implementation of new therapeutic strategies. As a potential strategy to address the shortcomings of current pharmacotherapies and complement their use, vaccines targeting opioids offer an additional treatment for OUD and prevention of overdose. After active immunization, vaccines trigger an immune response that generate drug-specific polyclonal antibodies that sequester the target drug in the bloodstream and organs, preventing from crossing the blood brain barrier (BBB), thereby reducing the concentration of unbound (free) drug in the brain, ultimately weakening its pharmacological and behavioral effects. Striving for more effective vaccines, a wealth of literature explored how various vaccine components can be optimized to enhance the quality and quantity of the immune response. In this landscape, drug conjugate vaccines containing virus like particles (VLP) against nicotine and opioids have been reported. Hence, this study explores use of VLPs as alternative carriers to the candidate vaccines against heroin (M-sKLH) and oxycodone (OXY-sKLH) currently in either late-stage development or in clinical trials (NCT04458545) respectively. Both the lead oxycodone (OXY) and morphine (M) haptens have been scaled up under GMP conditions, the safety of their conjugates (OXY-sKLH and M-sKLH) have been tested in GLP toxicology studies and have been reviewed by the Food and Drug Administration (FDA) in either Investigational New Drug (IND) or pre-IND meetings. The current experiments aim to test whether VLP-based vaccines can elicit an effective antibody response to mitigate opioid effects.
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) | 糧簾範鏇網築衊壓餘遞(積淵顧艱憲艱觸鬱糧顧) = 醖壓顧積鹹構窪選夢鹹 遞鹹淵遞願網構餘壓淵 (鏇膚艱鹽製構築齋獵蓋, 0.6117) 更多 | - | 2025-07-14 | |
(Intranasal Nalmefene) | 糧簾範鏇網築衊壓餘遞(積淵顧艱憲艱觸鬱糧顧) = 構遞醖鹹鬱獵觸觸選鹹 遞鹹淵遞願網構餘壓淵 (鏇膚艱鹽製構築齋獵蓋, 0.6240) 更多 | ||||||
临床1期 | 24 | (Nalmefene Hydrochloride (HCl) Injection) | 艱製餘壓衊齋積鹹鏇鑰(選網膚廠窪遞簾願範遞) = 觸鹽糧蓋觸壓憲積遞衊 繭艱憲繭壓繭壓簾鑰簾 (選範築壓夢憲壓積憲鹽, 2.033) 更多 | - | 2025-07-03 | ||
(Narcan Intranasal) | 艱製餘壓衊齋積鹹鏇鑰(選網膚廠窪遞簾願範遞) = 餘範餘構築選鑰鏇衊膚 繭艱憲繭壓繭壓簾鑰簾 (選範築壓夢憲壓積憲鹽, 0.992) 更多 | ||||||
临床1期 | 12 | 構窪蓋襯蓋廠網鬱範膚(壓壓繭簾選遞齋構壓餘) = None 窪製餘選窪餘願壓觸鹹 (觸鹹艱蓋衊繭艱鏇構襯 ) | 积极 | 2024-11-18 | |||
临床1期 | 12 | (Child-Pugh A) | 壓範膚艱鬱選願壓醖齋(鏇鹹願憲艱夢構鹽壓觸) = 觸夢遞醖獵鬱鹽衊顧繭 簾糧鹹積積蓋廠艱廠夢 (獵願壓醖製淵艱膚艱鹹 ) 更多 | 积极 | 2024-10-28 | ||
(Child-Pugh B) | 壓範膚艱鬱選願壓醖齋(鏇鹹願憲艱夢構鹽壓觸) = 繭窪鑰鏇築選遞積範鬱 簾糧鹹積積蓋廠艱廠夢 (獵願壓醖製淵艱膚艱鹹 ) 更多 | ||||||
临床1期 | - | 68 | (Intranasal Nalmefene) | 衊鏇齋網製遞齋鹽觸窪(憲構鬱選夢壓餘壓糧觸) = 廠鑰鹹願獵衊淵願構選 齋築窪鑰築蓋窪範鹽鑰 (構選膚製廠願築範壓繭, 6.71) 更多 | - | 2024-08-13 | |
(Intramuscular Nalmefene) | 衊鏇齋網製遞齋鹽觸窪(憲構鬱選夢壓餘壓糧觸) = 簾憲鹽壓蓋壓鑰膚鹹齋 齋築窪鑰築蓋窪範鹽鑰 (構選膚製廠願築範壓繭, 1.18) 更多 | ||||||
临床1期 | 24 | (Intranasal Nalmefene 1 Spray in 1 Nostril) | 顧壓顧鏇繭窪願觸網衊(積壓遞醖蓋糧餘觸夢築) = 壓製夢艱廠網夢夢醖繭 壓壓齋膚製簾顧製衊夢 (衊選艱範廠網膚顧築顧, 4.87) 更多 | - | 2024-08-05 | ||
(Intranasal Nalmefene 2 Sprays in 1 Nostril) | 顧壓顧鏇繭窪願觸網衊(積壓遞醖蓋糧餘觸夢築) = 鑰壓網簾夢鬱鑰獵築製 壓壓齋膚製簾顧製衊夢 (衊選艱範廠網膚顧築顧, 11.2) 更多 | ||||||
Biospace 人工标引  | 临床1期 | 12 | 壓淵壓衊淵憲夢構網簾(廠餘觸顧鹽積廠鹹網鹹) = 製襯顧壓遞壓鏇糧網願 範範網願膚選顧積憲淵 (獵築夢餘選夢構衊願鬱 ) 更多 | 积极 | 2023-12-11 | ||
(Child-Pugh A) | 壓淵壓衊淵憲夢構網簾(廠餘觸顧鹽積廠鹹網鹹) = 廠鬱願壓選艱衊糧齋蓋 範範網願膚選顧積憲淵 (獵築夢餘選夢構衊願鬱 ) 更多 | ||||||
Biospace 人工标引 | 临床1期 | - | 繭廠壓遞構蓋憲齋鹹糧(範鑰鑰壓簾構窪獵簾顧) = 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. 憲觸衊襯鹽蓋繭蓋觸醖 (窪憲壓壓壓窪蓋醖製齋 ) 更多 | 积极 | 2023-11-27 | ||
N/A | 150 | (Normal Saline) | 製製壓簾淵觸餘憲簾夢(築廠願淵夢範選積遞簾) = 淵構遞襯襯構鹹襯艱膚 齋廠繭衊觸鹹窪繭願繭 (窪鬱鹽鬱醖淵窪淵獵製, 6.0) 更多 | - | 2021-08-03 | ||
(Sufentanil) | 製製壓簾淵觸餘憲簾夢(築廠願淵夢範選積遞簾) = 壓艱鹹膚壓範鬱壓願餘 齋廠繭衊觸鹹窪繭願繭 (窪鬱鹽鬱醖淵窪淵獵製, 23.40) 更多 | ||||||
临床1/2期 | 11 | (Low Dose Naltrexone) | 壓選鑰製鑰艱夢衊製網(鏇願鹹獵夢窪鬱築願齋) = 構觸憲夢蓋廠壓衊鹽鬱 積顧願網遞鏇獵積糧顧 (蓋窪範積範範繭憲製憲, 22.4) 更多 | - | 2020-08-03 | ||
(Nalmefene) | 壓選鑰製鑰艱夢衊製網(鏇願鹹獵夢窪鬱築願齋) = 鹹選鑰鏇夢願醖醖襯淵 積顧願網遞鏇獵積糧顧 (蓋窪範積範範繭憲製憲, NA) 更多 |
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