Multimodal analgesia (MMA) is an essential part of Enhanced Recovery After Surgery (ERAS) protocol. The principle of MMA is to manage pain with analgesics of multiple classes acting on distinct target sites through different strategies. MMA can reduce the adverse reaction caused by opioids and improve the quality of recovery from surgery. Inadequate postoperative pain management will increase the risk of complications, including pneumonia, deep vein thrombosis, infection, delayed surgical healing, and chronic postoperative pain.

Start Date31 May 2024

Sponsor / Collaborator

China Medical University Hospital

NCT06344169 / Not yet recruitingPhase 2/3IIT

Efficacy of Parenteral Injection of an Extended Release Kappa-receptor Opioid Sebacoyl Dinalbuphine Ester for Pain Management After Cesarean Section: a Randomized, Open-label, Non-inferiority Trial

Inadequate postoperative pain management can lead to physical and psychological distress in patients as well as impact surgical wound healing and increase the risk of developing postoperative delirium and cardiopulmonary and thromboembolic events. Severe postoperative pain may also result in the development of chronic post-surgical pain (CPSP), which in turn can lead to prolonged use of opioids and increased health-care costs. A descriptive survey study in 60 postpartum women who received cesarean section suggested that the presence of postoperative pain significantly reduced the willingness of breastfeeding and infant care. The incidence of CPSP after cesarean delivery has been reported to vary from 1% to 18% up to 1 year after operation. Intrathecal morphine (ITM) injection is considered as the standard pain management strategy for post-cesarean pain. However, the overall analgesic effect of ITM is about 8-12h and it is associated with pruritus, nausea/vomiting, urinary retention, constipation, mental status change, and respiratory depression. Therefore, the development of a safe, conveniently operated, and long-lasting analgesic strategy, which serves as background pain control modality up to several days after cesarean section should provide clinically beneficial advantages in the management of acute postoperative pain and prevention of CPSP in postpartum women. Naldebain® is prodrug of nalbuphine, which was approved by the Taiwan FDA in 2017. Naldebain® is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine. The bioavailability of nalbuphine following intramuscular injection Naldebain® was 85.4%, and it took approximately 6 days for the complete release of Naldebain® into the blood circulation. Therefore, a single parenteral injection of Naldebain® could provide long lasting analgesic effect in several phase II trials. However, Naldebain® has not been tested in the pain control after cesarean section. Therefore, this PI-initiated prospective, randomized, open-label, non-inferiority trial aims to investigate the clinical efficacy of Naldebain® in management of acute postoperative pain in term parturient who receive elective cesarean section to provide analgesic effect that is not inferior to the standard ITM and prevent the development of CPSP.

Start Date15 Apr 2024

Sponsor / Collaborator-

NCT05842733 / Enrolling by invitationPhase 2

A Novel, Potent and Non-addictive Analgesic of Combinations for Knee Replacement Moderate to Severe Pain Management

To assess the safety, efficacy, and pharmacokinetics of oral SafeTynadol, Naldebain and Naldebain combine with SafeTynadol in the treatment of moderate to severe pain following knee replacement.

Start Date25 Jul 2023

Sponsor / Collaborator

Sinew Pharma, Inc.

100 Clinical Results associated with Dinalbuphine sebacate

100 Translational Medicine associated with Dinalbuphine sebacate

100 Patents (Medical) associated with Dinalbuphine sebacate

Literatures (Medical) associated with Dinalbuphine sebacate

01 Jun 2024·International Journal of Pharmaceutics

Amphiphilic NLC-Gel formulation loaded with Sebacoyl dinalbuphine ester and Nalbuphine for localized postoperative pain management

Article

Author: Chen, Yu-Wei ; Kuo, Cheng-Hsiang ; Liu, Yuan-Fu ; Tu, Ting-Yuan ; Lin, Cheng-Li ; Shyong, Yan-Jye ; Li, Yi-Lian ; Tsai, Jui-Chen

Opioids are powerful analgesics; however, their significant systemic adverse effects and the need for frequent administration restrict their use. Nalbuphine (NA) is a κ-agonist narcotic with limited adverse effects, but needs to be frequently administrated due to its short elimination half-life. Whereas sebacoyl dinalbuphine ester (SDE) is a NA prodrug, which can effectively prolong the analgesic effect, but lacks immediate pain relief. Therefore, in this study, a rapid and sustained local delivery formulation to introduce NA and SDE directly into surgical sites was developed. An amphiphilic nanostructured lipid carrier (NLC) poloxamer 407 (P407) gel (NLC-Gel) was developed to permit concurrent delivery of hydrophobic SDE from the NLC core and hydrophilic NA from P407, offering a dual rapid and prolonged analgesic effect. Benefiting from the thermal-sensitive characteristic of P407, the formulation can be injected in liquid phase and instantly transit into gel at wound site. NLC-Gel properties, including particle size, drug release, rheology, and stability, were assessed. In vivo evaluation using a rat spinal surgery model highlighted the effect of the formulation through pain behavior test and hematology analysis. NLC-Gels demonstrated an analgesic effect comparable with that of commercial intramuscular injected SDE formulation (IM SDE), with only 15 % of the drug dosage. The inclusion of supplemental NA in the exterior gel (PA12-Gel + NA) provided rapid drug onset owing to swift NA dispersion, addressing acute pain within hours along with prolonged analgesic effects. Our findings suggest that this amphiphilic formulation significantly enhanced postoperative pain management in terms of safety and efficacy.

01 Jun 2024·The Journal of Clinical Pharmacology

Breast Milk Excretion of Dinalbuphine Sebacate Injection Administered After Cesarean Section

Article

Author: Wang, Kai‐Yi ; Tang, Sung‐Ling ; Hsiao, Wen‐Kai ; Lin, Chi‐Kang

AbstractEnsuring the safety of analgesics during lactation is crucial for women of childbearing potential. Available data regarding the transfer of nalbuphine for postoperative acute pain via breast milk are limited to the postmarketing experience. This lactation study aimed to assess nalbuphine and dinalbuphine sebacate concentrations in breast milk from lactating women with postoperative pain treated with dinalbuphine sebacate extended‐release injection (150 mg dinalbuphine sebacate/2 mL Naldebain). Breast milk was collected throughout the 5‐day posthospitalization interval from 20 mothers injected with one dose of extended‐release dinalbuphine sebacate intramuscularly. Maternal safety was assessed during the study period. Nalbuphine was detectable in 71% of milk samples collected from all mothers, whereas dinalbuphine sebacate was undetectable or below the quantitation limit (0.1 ng/mL). The mean nalbuphine concentration in milk was approximately 10.55 ng/mL, with the peak concentration reaching up to 12.7 ng/mL. The mean relative infant dose was 0.39% (coefficient of variation, 65%). The mean pain intensity at rest was reduced to mild pain from Day 2 morning to discharge. Overall, the maternal safety profile was tolerable. The breast milk of women who receive one dose of dinalbuphine sebacate injection postpartum contains low nalbuphine concentration. In addition, dinalbuphine sebacate injection potentially reduces maternal pain intensity during the first postpartum week and offers low toxicity risk among breastfed infants.

01 Nov 2023·Biomedical chromatography : BMC

Validation of stability-indicating LC method, degradation study, and impact on antioxidant and antifungal activities of Eugenia uniflora leaves extract.

Article

Author: Lira Soares, Luiz Alberto ; Assunção Ferreira, Magda Rhayanny ; Barbosa Machado, Janaína Carla ; Dos Santos, Ewelyn Cintya Felipe ; Andrade de Lima, Juliana Morais

The aim of this study is to demonstrate the stability-indicating capacity of an analytical method for Eugenia uniflora, enhance understanding of the stability of myricitrin, and assess the effect of degradation of spray-dried extract (SDE) on antioxidant and antifungal activities. Validation of the stability-indicating method was carried out through a forced degradation study of SDE and standard myricitrin. The antioxidant and antifungal activities of SDE were evaluated both before and after degradation. The quantification method described was found to be both accurate and precise in measuring myricitrin levels in SDE from E. uniflora, with excellent selectivity that confirmed its stability-indicating capability. The forced degradation study revealed that the marker myricitrin is sensitive to hydrolysis, but generally stable under other stress conditions. By contrast, the standard myricitrin displayed greater susceptibility to degradation under forced degradation conditions. Analysis of the antioxidant activity of SDE before and after degradation showed a negative impact in this activity due to degradation, while no significant effect was observed on antifungal activity. The method described can be a valuable tool in the quality control of E. uniflora, and the findings can assist in determining the optimal conditions and storage of products derived from this species.

News (Medical) associated with Dinalbuphine sebacate

13 Nov 2017

·www.bioportfolio.com

Lumosa Therapeutics Co Ltd 6535 Financial and Strategic SWOT Analysis Review [Report Updated: 13112017] Prices from USD $300

Summary Lumosa Therapeutics Co Ltd Lumosa Therapeutics, formerly SunTen Phytotech Co Ltd is a developer of neurological and inflammatory drugs. The company's pipeline products comprise LT1001 for moderate to severe pain, LT2001 for tumor and cancer and LT3001 for acute ischemic stroke. Its activities comprise translational research, preclinical, intellectual property regulatory affairs, clinical development, project management and business development. Lumosa Therapeutics' products are used in the areas of neural, hypertension, diabetic foot ulcer, oncology and inflammatory diseases. The company partners with biotech and pharmaceutical companies for product licensing, development and commercialization. Lumosa Therapeutics is headquartered in Taipei, Taiwan. This comprehensive SWOT profile of Lumosa Therapeutics Co Ltd provides you an indepth strategic analysis of the company's businesses and operations. The profile has been compiled by GlobalData to bring to you a clear and an unbiased view of the company's key strengths and weaknesses and the potential opportunities and threats. The profile helps you formulate strategies that augment your business by enabling you to understand your partners, customers and competitors better. This company report forms part of GlobalData's Profile on Demand' service, covering over 50,000 of the world's leading companies. Once purchased, GlobalData's highly qualified team of company analysts will comprehensively research and author a full financial and strategic analysis of Lumosa Therapeutics Co Ltd including a detailed SWOT analysis, and deliver this direct to you in pdf format within two business days. excluding weekends. The profile contains critical company information including*, Business description A detailed description of the company's operations and business divisions. Corporate strategy Analyst's summarization of the company's business strategy. SWOT Analysis A detailed analysis of the company's strengths, weakness, opportunities and threats. Company history Progression of key events associated with the company. Major products and services A list of major products, services and brands of the company. Key competitors A list of key competitors to the company. Key employees A list of the key executives of the company. Executive biographies A brief summary of the executives' employment history. Key operational heads A list of personnel heading key departments/functions. Important locations and subsidiaries A list and contact details of key locations and subsidiaries of the company. Key manufacturing facilities A list of key manufacturing facilities of the company. Detailed financial ratios for the past five years The latest financial ratios derived from the annual financial statements published by the company with 5 years history. Interim ratios for the last five interim periods The latest financial ratios derived from the quarterly/semiannual financial statements published by the company for 5 interims history. Note*: Some sections may be missing if data is unavailable for the company. Key benefits of buying this profile include, You get detailed information about the company and its operations to identify potential customers and suppliers. The profile analyzes the company's business structure, operations, major products and services, prospects, locations and subsidiaries, key executives and their biographies and key competitors. Understand and respond to your competitors' business structure and strategies, and capitalize on their weaknesses. Stay up to date on the major developments affecting the company. The company's core strengths and weaknesses and areas of development or decline are analyzed and presented in the profile objectively. Recent developments in the company covered in the profile help you track important events. Equip yourself with information that enables you to sharpen your strategies and transform your operations profitably. Opportunities that the company can explore and exploit are sized up and its growth potential assessed in the profile. Competitive and/or technological threats are highlighted. Scout for potential investments and acquisition targets, with detailed insight into the companies' strategic, financial and operational performance. Financial ratio presented for major public companies in the profile include the revenue trends, profitability, growth, margins and returns, liquidity and leverage, financial position and efficiency ratios. Gain key insights into the company for academic or business research. Key elements such as SWOT analysis, corporate strategy and financial ratios and charts are incorporated in the profile to assist your academic or business research needs.

Financial StatementAcquisition

100 Deals associated with Dinalbuphine sebacate

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KEGG	Wiki	ATC	Drug Bank
-	Dinalbuphine sebacate	N02AF02	DB15341

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Pain	TW	Formosa Laboratories, Inc.	11 Jul 2016

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Analgesia	Phase 3	CN	Shanghai Xintan Venture Capital Co., Ltd.	04 Jun 2021
Analgesia	Phase 3	CN	Lumosa Therapeutics Co., Ltd.	04 Jun 2021
Moderate pain	Phase 3	CN	UBI Pharma Inc.	04 Jun 2021
Moderate pain	Phase 3	CN	Lumosa Therapeutics Co., Ltd.	04 Jun 2021
Moderate pain	Phase 3	CN	Shanghai Xintan Venture Capital Co., Ltd.	04 Jun 2021
Severe pain	Phase 3	CN	UBI Pharma Inc.	04 Jun 2021
Severe pain	Phase 3	CN	Shanghai Xintan Venture Capital Co., Ltd.	04 Jun 2021
Severe pain	Phase 3	CN	Lumosa Therapeutics Co., Ltd.	04 Jun 2021
Analgesia disorder	Discovery	TW	Lumosa Therapeutics Co., Ltd.	01 Dec 2012
Pain	Discovery	TW	Lumosa Therapeutics Co., Ltd.	01 Dec 2012

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