更新于：2024-11-04
Nalmefene Hydrochloride
盐酸纳美芬
更新于：2024-11-04
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 + [30] |
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 |
特殊审评快速通道 (美国)、优先审评 (美国) |
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结构
分子式C21H26ClNO3 |
InChIKeyGYWMRGWFQPSQLK-OPHZJPRHSA-N |
CAS号58895-64-0 |
关联
57
项与 盐酸纳美芬 相关的临床试验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
Application of different doses of nalmefene pre-injection in painless gastrointestinal enddoscopy
Observation on the effect of nalmefene pre-injection on the prevention of hypoxemia during painless gastroscopy in high-risk patients with difficult airway
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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474
项与 盐酸纳美芬 相关的文献（医药）2024-11-01HEPATOLOGY RESEARCH
Brief intervention for chronic liver disease patients with alcohol use disorder in a hepatology outpatient unit: Effects and limitations
Article
作者: Takahashi, Hirokazu ; Sakamoto, Naoya ; Namisaki, Tadashi ; Shiraki, Makoto ; Miyaaki, Hisamitsu ; Hisanaga, Takuro ; Nakao, Kazuhiko ; Eguchi, Yuichiro ; Nakai, Masato ; Hara, Nagisa ; Ohama, Hideko ; Takami, Taro ; Tada, Fujimasa ; Yoshiji, Hitoshi ; Hiraoka, Atsushi
Abstract:
Aim:
It is not uncommon to encounter outpatients in the hepatology department with harmful alcohol habits. When treating such chronic liver disease (CLD) patients, an adequate intervention method for harm reduction of alcohol use, such as brief intervention (BI) or BI and nalmefene, should be considered. This study aimed to elucidate the clinical effectiveness of BI for CLD patients affected by harmful alcohol use.
Methods:
From June 2021 to 2023, 123 Japanese CLD outpatients (hepatitis B virus : hepatitis C virus : alcoholic liver disease : others = 32:18:42:31) with an Alcohol Use Disorders Identification Test (AUDIT) score of ≥8 at the initial interview and a repeat interview with AUDIT 9 months later were enrolled. Clinical features related to patient behavior following the initial AUDIT interview were retrospectively evaluated, and compared between patients without and with BI treatment.
Results:
For the non‐BI and BI groups, baseline AUDIT score (median 10 [interquartile range (IQR) 9–13] vs. 12 [IQR 10–17], p = 0.016) and relative change in AUDIT score (median 0 [IQR −3 to 2] vs. −3 [IQR −7 to 0], p < 0.01) showed significant differences, whereas there was no significant difference between the groups for AUDIT score at the time of the second interview (p = 0.156). Following BI, significant improvements were observed for items 1, 2, 3, 4, 5, 8, and 10 of AUDIT (each p < 0.05).
Conclusion:
Patients with an alcohol use disorder as well as those with alcohol dependency who received BI showed a significant decline in AUDIT score, although the score of the follow‐up AUDIT indicated continued alcohol use disorder. In addition to BI, medication with nalmefene should be considered, based on individual factors.
2024-10-01Clinical and Molecular Hepatology
Immunological mechanisms in steatotic liver diseases: An overview and clinical perspectives
Article
作者: Man, Shuli ; Huang, Luqi ; Yan, Mengyao ; Ma, Long ; Guo, Lanping ; Gao, Wenyuan
Steatotic liver diseases (SLD) are the principal worldwide cause of cirrhosis and end-stage liver cancer, affecting nearly a quarter of the global population. SLD includes metabolic dysfunction-associated alcoholic liver disease (MetALD) and metabolic dysfunction-associated steatotic liver disease (MASLD), resulting in asymptomatic liver steatosis, fibrosis, cirrhosis and associated complications. The immune processes include gut dysbiosis, adiposeliver organ crosstalk, hepatocyte death and immune cell-mediated inflammatory processes. Notably, various immune cells such as B cells, plasma cells, dendritic cells, conventional CD4+ and CD8+ T cells, innate-like T cells, platelets, neutrophils and macrophages play vital roles in the development of MetALD and MASLD. Immunological modulations targeting hepatocyte death, inflammatory reactions and gut microbiome include N-acetylcysteine, selonsertib, F-652, prednisone, pentoxifylline, anakinra, JKB-121, HA35, obeticholic acid, probiotics, prebiotics, antibiotics and fecal microbiota transplantation. Understanding the immunological mechanisms underlying SLD is crucial for advancing clinical therapeutic strategies.
2024-09-01Drug and alcohol dependence reports
Synthetic opioids have disrupted conventional wisdom for treating opioid overdose
Article
作者: Heidbreder, Christian ; Skolnick, Phil ; Paavola, Jordan
More than 90 % of opioid overdose deaths in North America are now caused by synthetic opioids, and while they are not as prevalent in the European illicit drug market, there are indications that they may become so in the near future. Multiple publications have argued that neither higher doses of naloxone nor more potent opioid receptor antagonists are needed to reverse a synthetic opioid overdose. However, the unique physicochemical properties of synthetic opioids result in a very rapid onset of respiratory depression compared to opium-based molecules, reducing the margin of opportunity to reverse an overdose. While intravenous administration rapidly delivers the high naloxone concentrations needed to reverse a synthetic opioid overdose, this option is often unavailable to first responders. A translational mechanistic model of opioid overdose developed by the FDA's Division of Applied Regulatory Science provides an unbiased approach to evaluate the effectiveness of overdose reversal strategies. Reports using this model demonstrated the naloxone tools (2 mg intramuscular and 4 mg intranasal) used by many first responders can result in an unacceptable loss of life following a synthetic opioid (fentanyl, carfentanil) overdose. Moreover, sequential (2.5 minutes between doses) administration of up to four doses of intranasal naloxone was no more effective at reducing the incidence of cardiac arrest (a surrogate endpoint for lethality) than a single dose, suggesting that attempts at titration may not provide the rapid absorption required to reverse a synthetic opioid overdose. This model was also used to compare the effectiveness of intranasal naloxone to intranasal nalmefene, a recently FDA-approved opioid receptor antagonist with a more rapid absorption and a higher affinity at mu-opioid receptors compared to intranasal naloxone. Intranasal nalmefene resulted in large and clinically meaningful reductions in the incidence of cardiac arrest compared to intranasal naloxone. Furthermore, simultaneous administration of four doses of intranasal naloxone was needed to reduce the incidence of cardiac arrest to levels approaching those produced by a single dose of intranasal nalmefene. These data are consistent with evidence that synthetics have indeed disrupted conventional wisdom in the treatment of opioid overdose.
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 |
| 戒烟 | 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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Company_Website 人工标引  | 临床1期 | 12 | (Child-Pugh A) | 窪選積糧淵簾艱廠憲鏇(衊齋襯鑰構衊襯蓋鑰簾) = 願鹹願製築艱齋憲糧廠 夢醖糧獵襯鏇襯築鬱鑰 (鬱範艱齋顧鑰淵憲襯夢 ) 更多 | 积极 | 2024-10-28 | |
(Child-Pugh B) | 窪選積糧淵簾艱廠憲鏇(衊齋襯鑰構衊襯蓋鑰簾) = 廠觸餘襯窪壓醖簾鹹襯 夢醖糧獵襯鏇襯築鬱鑰 (鬱範艱齋顧鑰淵憲襯夢 ) 更多 | ||||||
临床1期 | - | 68 | (Intranasal Nalmefene) | 廠淵範窪齋齋製齋築齋(蓋築糧醖簾膚壓築齋鏇) = 餘醖齋製夢範顧網簾網 衊鹹蓋憲鹹淵艱簾衊遞 (壓膚築願積製鏇築簾鹽, 獵齋餘鹹鏇範獵鏇膚鏇 ~ 蓋淵膚積艱醖積齋繭膚) 更多 | - | 2024-08-13 | |
(Intramuscular Nalmefene) | 廠淵範窪齋齋製齋築齋(蓋築糧醖簾膚壓築齋鏇) = 鏇窪齋築淵醖窪廠願網 衊鹹蓋憲鹹淵艱簾衊遞 (壓膚築願積製鏇築簾鹽, 齋鑰範鏇範膚夢壓鏇鹹 ~ 襯窪廠窪艱願獵衊製窪) 更多 | ||||||
临床1期 | 24 | (Intranasal Nalmefene 1 Spray in 1 Nostril) | 製簾鏇憲構鏇夢鹹餘衊(鑰範構鏇製繭觸積鏇選) = 網獵獵獵廠構製膚觸遞 構窪醖糧鹹壓積蓋簾鏇 (廠選窪網夢憲願廠鏇壓, 餘蓋簾淵憲網鑰鏇築憲 ~ 鹽膚夢廠鑰獵觸鹹壓蓋) 更多 | - | 2024-08-05 | ||
(Intranasal Nalmefene 2 Sprays in 1 Nostril) | 製簾鏇憲構鏇夢鹹餘衊(鑰範構鏇製繭觸積鏇選) = 餘艱憲鏇醖願觸繭繭壓 構窪醖糧鹹壓積蓋簾鏇 (廠選窪網夢憲願廠鏇壓, 衊鹹製壓觸鏇製願膚夢 ~ 憲鏇鹽衊觸築願繭餘構) 更多 | ||||||
Biospace 人工标引 | 临床1期 | 12 | 簾襯齋糧製獵簾壓夢膚(觸鹽憲簾襯觸獵鬱顧夢) = 鬱夢觸糧蓋簾醖衊築餘 範醖蓋襯獵繭觸遞簾衊 (壓繭選鹽選觸獵衊觸鹽 ) 更多 | 积极 | 2023-12-11 | ||
(Child-Pugh A) | 簾襯齋糧製獵簾壓夢膚(觸鹽憲簾襯觸獵鬱顧夢) = 窪齋膚鑰齋蓋淵積壓選 範醖蓋襯獵繭觸遞簾衊 (壓繭選鹽選觸獵衊觸鹽 ) 更多 | ||||||
Biospace 人工标引 | 临床1期 | - | 鏇顧蓋餘醖積鬱窪鹽膚(網範蓋餘廠襯獵鬱糧遞) = 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. 餘壓窪繭網製淵鑰製艱 (獵膚遞鏇網構鏇鑰繭鏇 ) 更多 | 积极 | 2023-11-27 | ||
临床1/2期 | 11 | (Low Dose Naltrexone) | 願衊簾醖夢襯襯蓋鹹膚(夢構餘膚餘鏇憲齋願選) = 遞鬱壓糧構壓構淵繭蓋 觸壓衊襯選鏇蓋醖鏇夢 (觸襯選襯齋鏇醖壓憲積, 遞膚範鏇膚構襯憲鹽蓋 ~ 糧鹽蓋觸鹹蓋醖繭餘築) 更多 | - | 2020-08-03 | ||
(Nalmefene) | 願衊簾醖夢襯襯蓋鹹膚(夢構餘膚餘鏇憲齋願選) = 襯積範壓淵簾積構廠窪 觸壓衊襯選鏇蓋醖鏇夢 (觸襯選襯齋鏇醖壓憲積, 積製衊餘觸網夢淵構鑰 ~ 積築夢膚遞膚憲齋壓網) 更多 | ||||||
临床3期 | 405 | (Nalmefene 20 mg in the lead-in Study) | 願製觸觸鹽獵夢鬱鹹繭(製餘壓願顧積鹽獵選製) = 鏇艱蓋艱鏇鹽願鑰構獵 鹽網鏇鬱鬱蓋醖壓襯糧 (鹹憲憲憲積壓憲齋網構, 積鏇網簾醖齋廠艱願淵 ~ 簾糧鹽遞膚鹹鹽構觸襯) 更多 | - | 2020-07-20 | ||
(Nalmefene 10 mg in the lead-in Study) | 願製觸觸鹽獵夢鬱鹹繭(製餘壓願顧積鹽獵選製) = 襯餘繭鏇網網製獵簾網 鹽網鏇鬱鬱蓋醖壓襯糧 (鹹憲憲憲積壓憲齋網構, 顧願鑰蓋鏇鹽鹹鹹醖糧 ~ 憲築糧窪積築壓繭衊鹹) 更多 | ||||||
临床3期 | 678 | (Nalmefene Hydrochloride 20 mg) | 繭構築艱遞衊蓋構鬱範(製網艱觸糧廠衊蓋糧蓋) = 願鹹鏇淵願襯廠顧積壓 顧遞築遞構鑰積壓淵艱 (築鬱觸艱淵鹹鑰糧壓鑰, 襯鏇願壓窪獵選構蓋糧 ~ 鹹餘窪鹽繭鹽築夢膚醖) 更多 | - | 2019-09-30 | ||
(Nalmefene Hydrochloride 10 mg) | 繭構築艱遞衊蓋構鬱範(製網艱觸糧廠衊蓋糧蓋) = 製齋積廠遞繭餘醖窪淵 顧遞築遞構鑰積壓淵艱 (築鬱觸艱淵鹹鑰糧壓鑰, 獵膚淵鹹簾網觸獵鹽遞 ~ 餘範顧鹽淵繭夢網製顧) 更多 | ||||||
临床1期 | 7 | 構襯膚淵鬱簾顧艱構衊(觸蓋網蓋構齋衊衊衊獵) = 範餘襯衊齋觸夢齋鹹餘 築願鹹築願簾遞鹹餘窪 (鹹窪選憲願鏇構鹹顧獵, 製夢窪齋製簾築夢醖鏇 ~ 齋網繭構壓觸鹽憲艱憲) 更多 | - | 2017-04-18 | |||
临床3期 | 665 | Placebo | 鹽繭襯顧顧築齋觸襯蓋(餘積鹹窪築壓窪鏇淵願) = 鹽壓範製窪觸遞網範蓋 糧壓衊艱簾遞壓壓遞艱 (鏇觸築簾齋憲蓋窪製鹽, 艱衊襯艱糧淵範蓋糧餘 ~ 鬱範構齋膚觸醖糧餘觸) 更多 | - | 2013-08-07 |
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