[Translation] A multicenter, randomized, double-blind, double-dummy, parallel, positive-controlled clinical trial to evaluate the efficacy and safety of morphine sulfate and naltrexone hydrochloride extended-release capsules in patients with moderate to severe cancer pain

采用多中心、随机、双盲双模拟、平行、阳性对照的方法，在中至重度癌痛患者中评价硫酸吗啡盐酸纳曲酮缓释胶囊的有效性和安全性

[Translation]

A multicenter, randomized, double-blind, double-dummy, parallel, positive-controlled method was used to evaluate the efficacy and safety of morphine sulfate and naltrexone hydrochloride sustained-release capsules in patients with moderate to severe cancer pain.

Start Date05 Feb 2024

Sponsor / Collaborator

Chengdu Easton Biopharmaceuticals Co., Ltd.

[+1]

CTR20233537 / CompletedNot Applicable

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

[Translation] A single-center, randomized, open-label, single-dose, three-period pharmacokinetic comparison of crushed morphine sulfate and naltrexone hydrochloride extended-release capsules, intact morphine sulfate and naltrexone hydrochloride extended-release capsules, and naltrexone hydrochloride solution in patients with chronic non-cancer pain

主要目的：比较碾碎的硫酸吗啡盐酸纳曲酮缓释胶囊（成都苑东生物制药股份有限公司）与盐酸纳曲酮溶液在轻、中度慢性疼痛患者中的纳曲酮及其代谢产物6-β纳曲醇的药代动力学特征。

[Translation]

Primary objective: To compare the pharmacokinetic characteristics of naltrexone and its metabolite 6-β-naltrexol in patients with mild to moderate chronic pain using crushed morphine sulfate naltrexone hydrochloride sustained-release capsules (Chengdu Yuandong Biopharmaceutical Co., Ltd.) and naltrexone hydrochloride solution.

Start Date23 Oct 2023

Sponsor / Collaborator

Chengdu Easton Biopharmaceuticals Co., Ltd.

[+1]

CTR20232248 / CompletedNot Applicable

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

[Translation] Comparative study on the pharmacokinetics of morphine sulfate naltrexone hydrochloride sustained-release capsules and morphine sulfate sustained-release tablets

比较空腹状态和餐后状态下，硫酸吗啡盐酸纳曲酮缓释胶囊（成都苑东生物制药股份有限公司）与硫酸吗啡缓释片（商品名：美施康定，持证商：Napp Pharmaceuticals Limited）在轻、中度慢性疼痛患者中单次给药的药代动力学特征。

[Translation]

To compare the pharmacokinetic characteristics of single-dose morphine sulfate naltrexone hydrochloride sustained-release capsules (Chengdu Yuandong Biopharmaceutical Co., Ltd.) and morphine sulfate sustained-release tablets (trade name: MS Contin, licensee: Napp Pharmaceuticals Limited) in patients with mild to moderate chronic pain under fasting and fed conditions.

Start Date30 Jul 2023

Sponsor / Collaborator

Chengdu Easton Biopharmaceuticals Co., Ltd.

[+1]

100 Clinical Results associated with Morphine Sulfate/Naltrexone Hydrochloride

100 Translational Medicine associated with Morphine Sulfate/Naltrexone Hydrochloride

100 Patents (Medical) associated with Morphine Sulfate/Naltrexone Hydrochloride

Literatures (Medical) associated with Morphine Sulfate/Naltrexone Hydrochloride

03 Apr 2019·Postgraduate MedicineQ4 · MEDICINE

Real-world misuse, abuse, and dependence of abuse-deterrent versus non-abuse-deterrent extended-release morphine in Medicaid non-cancer patients

Q4 · MEDICINE

Article

Author: Webster, Lynn R. ; Roland, Carl L. ; Polson, Michael ; Mendoza, Mario ; Dart, Richard C. ; Park, Peter W. ; Cattaneo, Michael ; Schnoll, Sidney H. ; Mardekian, Jack ; Cicero, Theodore J.

OBJECTIVEOpioids 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.METHODSAdministrative 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.RESULTSThere 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.CONCLUSIONMisuse, abuse, and dependence events were numerically lower in patients receiving ER-MSN compared with those receiving ERM products.

03 Mar 2016·Current Medical Research and OpinionQ4 · MEDICINE

Safety profile of extended-release morphine sulfate with sequestered naltrexone hydrochloride in older patients: pooled analysis of three clinical trials

Q4 · MEDICINE

Article

Author: Webster, Lynn R. ; Pixton, Glenn C. ; Setnik, Beatrice

OBJECTIVEClinical 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 METHODSSubgroup 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 REGISTRATIONClinicalTrials.gov: NCT00420992, NCT00415597.RESULTSDuring 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.CONCLUSIONSSafety 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.

01 May 2014·Drug and Alcohol DependenceQ2 · MEDICINE

Development and impact of prescription opioid abuse deterrent formulation technologies

Q2 · MEDICINE

Review

Author: Fanelli, Richard J ; Stiles, Gary L ; Weingarten, Brianne ; Mannion, Richard O ; Alexander, Louis

BACKGROUNDMillions of patients are treated with opioid analgesics (OpAs) to relieve pain. Unfortunately, these medications are subject to abuse and/or unintended misuse. Abuse deterrent formulations (ADFs) represent an intervention strategy to decrease abuse/misuse without affecting patient access. The Food and Drug Administration (FDA) has issued Draft Guidance "Abuse deterrent opioids, Evaluation and Labeling" and is currently actively pursuing scientific input on this issue.METHODSThe development of ADF technologies was reviewed using peer reviewed journals describing OpA post marketing studies, web sites containing FDA announcements on product approvals and manufacturer product use profiles.RESULTSReviewed is the FDA recent approval of a product label describing the abuse deterrent characteristics of OxyContin(®) (physical barrier formulation), and the FDA determination that studies were insufficient for an Opana(®) (physical barrier) ADF label. Additional reviewed marketed OpAs with ADF technologies include: Suboxone(®) and Embeda(®) (opioid agonist/antagonist combinations), Oxecta(®) (aversion technology), and Nucynta(®) (physical barrier). Reviewed ADF technologies currently in development include: new physical barrier and aversion technologies, an innovative extended release formulation as well as novel polymer-opioid conjugates. As ADF technologies are part of a comprehensive intervention strategy to promote safe OpA use, additional components including governmental, community, and educational initiatives are reviewed.CONCLUSIONSThe outcomes of the recent ADF labeling applications for OxyContin(®) (Tier 3 approval) and Opana(®) (non-approval) suggest that the threshold for ADF labeling will be appropriately high. The presented findings indicate that ADF technologies can be a critical component of a comprehensive strategy to promote the safe and effective use of OpAs.

100 Deals associated with Morphine Sulfate/Naltrexone Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Morphine Sulfate/Naltrexone Hydrochloride	-	-

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Cancer Pain	Phase 3	CN	Chengdu Easton Biopharmaceuticals Co., Ltd.	05 Feb 2024
Chronic Pain	Phase 3	US	Pfizer Inc.	01 Dec 2006
Opioid abuse	Discovery	US	Pfizer Inc.	01 Feb 2011
Analgesia	Discovery	-	Pfizer Inc.	01 Aug 2010
Narcotic-Related Disorders	Discovery	-	Pfizer Inc.	01 Aug 2010
Opioid-Related Disorders	Discovery	-	Pfizer Inc.	01 Aug 2010

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00415597 (CTgov)	Phase 3	Chronic Pain	467	ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)	otvqocnctd(rmivjntzhv) = tkkjasghep vwsxqzcoxy (ehnkttfext, fwmdsmloih - vvfrwexlqq) View more	-	29 Oct 2009

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