预约演示
更新于：2025-07-20
Morphine Sulfate/Naltrexone Hydrochloride
盐酸纳曲酮/硫酸吗啡水合物
更新于：2025-07-20
概要
基本信息
原研机构 |
权益机构- |
最高研发阶段临床3期 |
首次获批日期 美国 (2009-08-13), |
最高研发阶段(中国)临床3期 |
特殊审评- |
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结构/序列
分子式C74H88Cl2N4O18S |
InChIKeyFFSBSYUGIGJQOU-INJDZLCSSA-N |
CAS号1131418-84-2 |
关联
13
项与 盐酸纳曲酮/硫酸吗啡水合物 相关的临床试验CTR20240009
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碾碎的硫酸吗啡盐酸纳曲酮缓释胶囊、完整的硫酸吗啡盐酸纳曲酮缓释胶囊和盐酸纳曲酮溶液在慢性非癌性疼痛患者中的单中心、随机、开放、单剂量、三周期药代动力学对比研究
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硫酸吗啡盐酸纳曲酮缓释胶囊与硫酸吗啡缓释片的药代动力学对比研究
100 项与 盐酸纳曲酮/硫酸吗啡水合物 相关的临床结果
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100 项与 盐酸纳曲酮/硫酸吗啡水合物 相关的转化医学
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100 项与 盐酸纳曲酮/硫酸吗啡水合物 相关的专利（医药）
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29
项与 盐酸纳曲酮/硫酸吗啡水合物 相关的文献（医药）2019-04-03Postgraduate medicine4区 · 医学
Real-world misuse, abuse, and dependence of abuse-deterrent versus non-abuse-deterrent extended-release morphine in Medicaid non-cancer patients
4区 · 医学
Article
作者: Schnoll, Sidney H. ; Dart, Richard C. ; Polson, Michael ; Mardekian, Jack ; Cattaneo, Michael ; Roland, Carl L. ; Park, Peter W. ; Cicero, Theodore J. ; Mendoza, Mario ; Webster, Lynn R.
OBJECTIVE:
Opioids with abuse-deterrent properties may reduce widespread abuse, misuse, and diversion of these products. This study aimed to quantify misuse, abuse, dependence, and health resource use of extended-release morphine sulfate with sequestered naltrexone hydrochloride (ER-MSN; EMBEDA®), compared with non-abuse-deterrent extended-release morphine (ERM) products in Medicaid non-cancer patients.
METHODS:
Administrative medical and pharmacy claims data were analyzed for 10 Medicaid states from 1 January 2015, to 30 June 2016. Patients were included if they received a prescription for ER-MSN or any oral, non-abuse-deterrent ERM. Index date was the date of first prescription for an ER-MSN or ERM. Abuse/dependence, non-fatal overdose, emergency department (ED) visits, and ED/inpatient readmissions were determined for each participant. An overall measure of misuse and abuse was also calculated. To account for differences in follow-up, all counts are expressed per 100 patient-years.
RESULTS:
There were 4,857 patients who received ER-MSN and 10,357 who received an ERM. The average age in the two cohorts was approximately 45 years old. From pre-index to follow-up, the number of patients per 100 patient-years with a diagnosis code indicating abuse or dependence increased by 0.91 (95% confidence interval [CI]: 0.85, 0.97) in the ER-MSN cohort and 2.23 (95% CI: 2.14, 2.32) in the ERM cohort. The number of patients per 100 patient-years with an opioid-related non-fatal overdose increased by 0.05 (95% CI: 0.04, 0.06) in the ER-MSN cohort compared with 0.11 (95% CI: 0.09, 0.13) in the ERM cohort. The opioid abuse overall composite score increased by 1.36 (95% CI: 1.24, 1.48) in the post-index period in the ER-MSN cohort compared to 3.21 (95% CI: 3.10, 3.32) in the ERM cohort.
CONCLUSION:
Misuse, abuse, and dependence events were numerically lower in patients receiving ER-MSN compared with those receiving ERM products.
2018-02-01Clinical therapeutics4区 · 医学
Challenges Involved in the Development and Delivery of Abuse-deterrent Formulations of Opioid Analgesics
4区 · 医学
Article
作者: Cohen, Joshua P ; Roland, Carl ; Mendoza, Mario
PURPOSE:
This commentary examines the development, regulatory, and reimbursement challenges facing abuse-deterrent formulation (ADF) products.
METHODS:
In January 2017, the Tufts Center for the Study of Drug Development convened a roundtable to explore clinical development, regulatory, and reimbursement challenges with respect to ADFs of opioid analgesics. Roundtable participants, who included a range of pharmaceutical industry and other experts, discussed multiple challenges.
FINDINGS:
First, several key clinical development challenges were identified and discussed. These challenges pertain to prodrug development and development of deterrents against oral abuse. Second, experts suggested that more clarity is needed from regulatory authorities regarding standards for proving ADF labeling claims and for being rewarded with 3-year data exclusivity. Similarly, given the substantial burdens associated with the development of postapproval evidence generation, experts raised the need for a consistent regulatory policy related to postapproval evidence generation for all ADFs (branded and generic). Third, despite the public health benefits of certain ADF products, current coverage and access policies impede patient access. Payer justification for restrictive policies appears to be based more on budget impact considerations than cost-effectiveness. Fourth, there remains a need to further expand the evidence base regarding clinical and cost-effectiveness as well as abuse deterrence in a real-world setting for all ADF products.
IMPLICATIONS:
Clinical development challenges need to be overcome with respect to novel ADF technologies, such as prodrugs and deterrents against oral abuse. More clarity is needed from regulatory authorities on labeling claims and data exclusivity eligibility with respect to ADFs. Ensuring prescriber training and awareness of various options for treating pain, including ADF products, is an important step, as is educating payers about the public health benefits of ADFs in appropriate subpopulations of pain patients. In addition, physicians may need to incorporate appropriate risk stratification methods. Finally, it is important to establish a level playing field between coverage of ADF and non-ADF products so that non-ADF products are not given preferred formulary placement.
2016-03-03Current medical research and opinion4区 · 医学
Safety profile of extended-release morphine sulfate with sequestered naltrexone hydrochloride in older patients: pooled analysis of three clinical trials
4区 · 医学
Article
作者: Setnik, Beatrice ; Webster, Lynn R. ; Pixton, Glenn C.
OBJECTIVE:
Clinical trial safety data following chronic administration of extended-release opioids within an older population is limited. Embeda * is an extended-release formulation of morphine sulfate surrounding sequestered naltrexone hydrochloride (MSN) and is designed to deter opioid misuse and abuse. The present analysis compared pooled safety outcomes among patients aged ≥65 years and those aged <65 years from three phase 2/3 studies (ranging from 2 weeks to 12 months) in patients treated with MSN.
RESEARCH DESIGN AND METHODS:
Subgroup analysis of patients aged ≥65 years and <65 years was performed on pooled data for adverse events (AEs), potentially clinically significant laboratory values (hematology/chemistry), and signs/symptoms of opioid withdrawal using the Clinical Opiate Withdrawal Scale (COWS) (phase 3 trials only) for patients who received at least one dose (short-term studies, maximum dose was 160 mg/d or 320 mg/d depending on study; long-term study, no maximum dose) of study medication during titration and maintenance phases.
CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov: NCT00420992, NCT00415597.
RESULTS:
During titration, 173 (17.1%) of 1012 patients treated with MSN were aged ≥65 years, while during maintenance 76/564 (13.5%) patients were aged ≥65 years. Treatment-emergent AEs were similar in frequency and type between the two cohorts, with the most common being constipation, nausea, and somnolence; no consistent patterns relating to age and only one possibly treatment-related serious AE in patients ≥65 years was noted. No clinically significant differences in laboratory values or COWS scores (average maximum score ≤2.5) were observed between age groups.
CONCLUSIONS:
Safety outcomes following daily administration of MSN (2 weeks-12 months) were similar between patients aged ≥65 years and <65 years. Key limitations include the variable study designs and length of treatment (2 weeks-12 months), small sample size, and the inclusion of only those patients who were otherwise in relatively good health with restrictions on concomitant medications.
5
项与 盐酸纳曲酮/硫酸吗啡水合物 相关的新闻（医药）2024-12-11
·米内网
上市批准医药出海申请上市
2024-12-01
·信狐药迅
细胞疗法申请上市免疫疗法临床申请ASH会议
2024-12-01
·药筛
100 项与 盐酸纳曲酮/硫酸吗啡水合物 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | 盐酸纳曲酮/硫酸吗啡水合物 | - | - |
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 |
|---|---|---|---|
| 疼痛 | 美国 | 2009-08-13 |
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 |
|---|---|---|---|---|
| 癌症疼痛 | 临床3期 | 中国 | 2024-02-05 | |
| 慢性疼痛 | 临床3期 | 美国 | 2006-12-01 | |
| 膝关节炎 | 临床3期 | 美国 | 2006-12-01 | |
| 阿片滥用 | 临床1期 | 美国 | 2011-02-01 | |
| 镇痛 | 临床1期 | - | 2010-08-01 | |
| 麻醉相关疾病 | 临床1期 | - | 2010-08-01 | |
| 阿片相关性障碍 | 临床1期 | - | 2010-08-01 |
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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4期 | 684 | naltrexone hydrochloride+morphine sulfate+EMBEDA | 積觸醖鑰積淵艱鹽鑰憲 = 觸願夢蓋壓齋願鑰醖範 艱遞壓壓獵壓衊鏇遞積 (醖繭夢網構鏇鑰觸製壓, 艱淵構鹽顧餘範構壓糧 ~ 顧鏇窪餘觸簾襯鏇顧觸) 更多 | - | 2012-09-05 | ||
临床4期 | 14 | placebo+EMBEDA (EMBEDA Whole Capsules) | 築鏇醖窪構製蓋憲鏇壓 = 觸積蓋獵鏇願鏇糧構鬱 壓築顧餘範蓋蓋選網範 (壓選鏇鹽積鏇糧選網遞, 廠顧壓鹹範範蓋簾醖襯 ~ 蓋憲願壓窪廠艱繭簾鹽) 更多 | - | 2012-03-28 | ||
placebo+EMBEDA (EMBEDA Crushed in Solution) | 築鏇醖窪構製蓋憲鏇壓 = 鹹製鬱選憲衊鏇範衊襯 壓築顧餘範蓋蓋選網範 (壓選鏇鹽積鏇糧選網遞, 蓋簾鹹築壓繭襯構鏇鹽 ~ 鏇艱觸鏇願襯鏇齋糧餘) 更多 | ||||||
临床3期 | 467 | 鬱衊糧繭鹹範壓糧簾獵 = 範餘簾製構選鹹蓋廠獵 衊鑰膚簾齋選選糧憲衊 (廠網選簾廠憲築鹽糧淵, 遞廠觸觸觸築選襯選膚 ~ 觸窪醖繭選繭艱憲鬱觸) 更多 | - | 2009-10-29 |
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