Delving into the Latest Updates on Dexketoprofen Trometamol with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Arveles, Desketo, Dexketoprofen

+ [23]

Target

COX-1 x COX-2

Mechanism

COX-1 inhibitors(Cyclooxygenase-1 inhibitors), COX-2 inhibitors(Cyclooxygenase-2 inhibitors)

Therapeutic Areas

Nervous System Diseases

Active Indication

Pain, PostoperativeMigraine DisordersPain+ [3]

Inactive Indication

AnalgesiaColicModerate pain+ [1]

Originator Organization

Huangshi Shixing Pharmaceutical Co., Ltd.

Active Organization

Huangshi Shixing Pharmaceutical Co., Ltd.

Jiangsu Nhwa Pharmaceutical Co., Ltd.

Shanxi Pude Pharmaceutical Co., Ltd.

+ [2]

Inactive Organization

Guangzhou Yongzheng Pharmaceutical Co.,Ltd.Germany Berlin Chemical Co., Ltd. Beijing Office

A. Menarini Industrie Farmaceutiche Riunite SRL

Drug Highest PhaseApproved

First Approval Date

CN (27 Oct 2006),

Migraine DisordersPain

Regulation-

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Structure

Molecular FormulaC16H14O3

InChIKeyDKYWVDODHFEZIM-NSHDSACASA-N

CAS Registry22161-81-5

Primary objective: To evaluate the effectiveness of dexketoprofen tromethamine injection in the treatment of postoperative pain after abdominal and orthopedic surgery. Secondary objective: To evaluate the safety of dexketoprofen tromethamine injection in the treatment of postoperative pain after abdominal and orthopedic surgery.

Start Date24 Apr 2024

Sponsor / Collaborator

Shanxi Pude Pharmaceutical Co., Ltd.

[+1]

CTR20240398 / RecruitingPhase 1

评估右酮洛芬氨丁三醇注射液在中国健康受试者中的药代动力学研究—— 一项单中心、随机、开放的I期临床研究

[Translation] Evaluation of the pharmacokinetics of dexketoprofen tromethamine injection in healthy Chinese subjects: a single-center, randomized, open-label phase I clinical study

主要目的：评估右酮洛芬氨丁三醇注射液在中国健康受试者中单、多次给药后的药代动力学特征。次要目的：评估右酮洛芬氨丁三醇注射液在中国健康受试者中单、多次给药后的安全性。

[Translation]

Primary objective: To evaluate the pharmacokinetic characteristics of dexketoprofen tromethamine injection after single and multiple administrations in healthy Chinese subjects. Secondary objective: To evaluate the safety of dexketoprofen tromethamine injection after single and multiple administrations in healthy Chinese subjects.

Start Date07 Apr 2024

Sponsor / Collaborator

Shanxi Pude Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Dexketoprofen Trometamol

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100 Translational Medicine associated with Dexketoprofen Trometamol

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100 Patents (Medical) associated with Dexketoprofen Trometamol

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473

Literatures (Medical) associated with Dexketoprofen Trometamol

17 Oct 2024·BMJ open

Real-world usage pattern, effectiveness and safety of oral tramadol/dexketoprofen trometamol fixed-dose combination in moderate-to-severe acute pain in Asia: a prospective, multicentre, observational study.

Article

Author: Raju, Gopinathan ; Eufemio, Edgar Michael ; Ho, Kok Yuen ; Dimayuga, Cesar ; Roohi, Sharifah Ahmad ; Waithayayothin, Kritsadakorn ; Sawaddiruk, Passakorn ; Gupta, Ankur ; Chong, Keen Wai ; Castro, Marc Anthony L ; Bernardo, Edwin ; Wilairatana, Vajara ; Oon, Zhi Hao ; Nagrale, Dinesh ; Tangwiwat, Suwimon ; Salvador, Roehl C ; Gyanwali, Bibek ; Ona, Leonardo

OBJECTIVESThis study aims to determine the usage pattern, effectiveness and safety of oral tramadol 75 mg and dexketoprofen trometamol 25 mg fixed-dose combination (TRAM/DKP FDC) in the short-term treatment of moderate-to-severe acute pain in real-world clinical practice in Asia.DESIGNReal-world, prospective, multicentre, observational, phase IV study.SETTING13 tertiary-care hospital sites across the Philippines, Thailand, Malaysia and Singapore.PARTICIPANTSAdult patients aged 18-80 years prescribed TRAM/DKP FDC for the short-term (up to 5 days) treatment of moderate-to-severe acute pain.MAIN OUTCOME MEASURESPrimary endpoints were the proportion of patients prescribed TRAM/DKP FDC with different types of postsurgical and non-surgical treatments, and the average dosing frequency and duration of TRAM/DKP FDC treatment. Secondary endpoints were the proportion of patients achieving ≥30% pain reduction at 8 hours post the first dose (pain severity was assessed using the 11-point Numeric Pain Rating Scale); patient satisfaction at the end of treatment (based on a 5-point Patient Global Evaluation Scale (PGE)) and safety including the incidence of adverse drug reactions (ADRs).RESULTSAmong 599 patients (median age 44 years, 61.3% female) enrolled in this study, 68.61% (n=411) were postsurgical and 31.39% (n=188) were non-surgical patients. TRAM/DKP FDC was prescribed in a diverse group of postsurgical patients (eg, orthopaedic, general and cancer surgery) as well as in non-surgical conditions (eg, lower back pain and musculoskeletal pain). In the majority of patients, TRAM/DKP FDC was prescribed every 8 hours (65.94%) and for 5 days (78.80%). There was a significant reduction in pain intensity throughout the study and 65% of patients achieved ≥30% pain reduction from baseline at 8 hours post the first dose of TRAM/DKP FDC on day 1. 95.69% of patients were satisfied with the treatment (rated good, very good and excellent on the PGE scale). Overall, 13.9% of patients reported ADRs; most were mild to moderate in severity. The most common ADRs were nausea, vomiting and dizziness.CONCLUSIONThis study showed that TRAM/DKP FDC was used in diverse types of postsurgical and non-surgical patients in the real-world setting in Asia. It effectively reduced pain and was well tolerated with a high level of patient satisfaction.

01 Sep 2024·Heliyon

Immune modulation by dexketoprofen trometamol, a selective eicosanoid biosynthesis inhibitor of cellular immune response and phenoloxidase reaction in response to viral infection in Pimpla turionellae adults

Article

Author: Çelik, Cihat

Nodulation is the first immune defence mechanism related to melanisation in response to microbial infections in insects. Adult parasitoid insects have been hypothesised to produce nodules with melanisation in response to viral infections and, eicosanoids, to mediate nodulation reactions and phenoloxidase (PO) activation in this type of infections. To test this hypothesis, endoparasitoid Pimpla turionellae adults were first inoculated with a novel generation nonsteroidal anti-inflammatory drug (NSAID) dexketoprofen trometamol (DT) (5 μg/adult), which is a selective cyclooxygenase-1 (COX-1) inhibitor. These adults were then immediately injected with intrahaemocoelic injection of Bovine herpes simplex virus-1 (BHSV-1) as a model insect-virus interaction. Additionally, adults were fed on artificial diet with increasing concentrations of DT (0.001, 0.01, or 0.1 g/100 ml diet) per os prior to intrahaemocoelic injection of BHSV-1 (2 × 10³ PFU/adult) and nodulation and PO activity were recorded at 2 h post inoculation (PI). BHSV-1-treated newly emerged adults fed with inhibitors showed low levels of nodulation and increased PO enzyme activity. DT-treated Pimpla adults produced significantly fewer nodules (approximately nine nodules/adult), whereas viral infection provoked nodules (approximately 33 nodules/adult) in comparison with needle (vehicle)-treated controls (approximately five nodules/adult). Increasing dietary dexketoprofen trometamol concentrations decreased nodulation (by 12-fold at the highest concentration) and increased PO reactions (by approximately 3-fold at the highest concentration) to BHSV-1 injection. Compared with control adults, adults orally fed on the lowest DT concentration (0.001 %) significantly increased PO activity (1.22 ± 0.23-2.74 ± 0.31 unit/min/mg protein) while nodules significantly decreased (43.19 ± 4.26-17.84 ± 2.19) in response to virus infections. These findings suggest that eicosanoid biosynthesis, at least in the context of prostaglandins (PGs) formed by COX-1, mediates nodulation reactions and PO activation in response to viral infection in adults of this endoparasitoid. This is the first demonstration that the immune response of P. turionellae adults to viral pathogens is modulated by DT, which initiates haemolymph PO activation.

01 Aug 2024·European Journal of Trauma and Emergency Surgery

Comparison of analgesic efficacy of ibuprofen and dexketoprofen in pain management of long bone fractures: a prospective, randomized, double-blind study

Article

Author: Akbas, İlker ; Kaya, Bekir ; Dönmez, Safa ; Sener, Alp ; Yenal, Kadir ; Ishak Isık, Nurullah

INTRODUCTIONLong bone fractures (LBF) often cause severe pain, impacting patients' quality of life. This prospective, randomized, double-blind study aimed to compare the analgesic efficacy of dexketoprofen (Dex) and ibuprofen (Ibu) in LBF patients in the emergency department.METHODSConducted between August 10, 2023, and January 17, 2024, the study included 100 eligible patients randomized into Dex and Ibu groups. Visual analog scale (VAS) scores were measured at baseline and at 30, 60, and 120 min. DeltaVAS (ΔVAS) values and ΔVAS percentages (ΔVAS%) were calculated. Primary endpoints were ΔVAS scores (ΔVAS 30-60-120) and ΔVAS% for comparative analysis.RESULTSStatistical analysis showed no significant difference in ΔVAS30 (p = 0.359). However, ΔVAS60 exhibited a significant difference (p = 0.027), as did ΔVAS120 (p = < 0.001). ΔVAS%30 showed no significance (p = 0.224), but ΔVAS%60 and ΔVAS%120 were clinically and statistically significant (p = 0.017 and p = < 0.001, respectively).CONCLUSIONIbuprofen 800 mg demonstrated superior analgesic efficacy at 60 and 120 min compared to Dex in long bone fractures. These findings suggest ibuprofen's potential as an effective pain management option in emergency departments.

100 Deals associated with Dexketoprofen Trometamol

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Dexketoprofen Trometamol	M02AA27 M01AE17	DB09214

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pain, Postoperative	CN	Nanjing Zenkom Pharmaceutical Co., Ltd.	29 May 2023
Migraine Disorders	CN	Huangshi Shixing Pharmaceutical Co., Ltd.	27 Oct 2006
Pain	CN	Huangshi Shixing Pharmaceutical Co., Ltd.	27 Oct 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Pain	Phase 3	CN	Jiangsu Nhwa Pharmaceutical Co., Ltd.	02 Nov 2023
Colic	Phase 1	CN	Guangzhou Yongzheng Pharmaceutical Co.,Ltd.	27 Dec 2018
Low Back Pain	Phase 1	CN	Guangzhou Yongzheng Pharmaceutical Co.,Ltd.	27 Dec 2018
Back Pain	Phase 1	CN	Germany Berlin Chemical Co., Ltd. Beijing Office	15 Jul 2015
Pain, Postoperative	Phase 1	CN	Germany Berlin Chemical Co., Ltd. Beijing Office	15 Jul 2015
Renal Colic	Phase 1	CN	Germany Berlin Chemical Co., Ltd. Beijing Office	15 Jul 2015
Analgesia	Preclinical	CN	Germany Berlin Chemical Co., Ltd. Beijing Office	16 Oct 2015
Moderate pain	Preclinical	CN	Germany Berlin Chemical Co., Ltd. Beijing Office	16 Oct 2015
Severe pain	Preclinical	CN	Germany Berlin Chemical Co., Ltd. Beijing Office	16 Oct 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01902134 \| EUCTR2012-004548-31-CZ (Pubmed \| Vet Anaesth Analg)	Phase 3	Severe pain \| Moderate pain	641	Dexketoprofen/tramadol 25 mg/75 mg	usjdnqimcj(ovgxsircag): P-Value = 0.019	Positive	01 Feb 2016
				Dexketoprofen 25 mg
NCT02159547 (CTgov)	Phase 4	Migraine Disorders	224	Dexketoprofen (Dexketoprofen)	iibyjiwkth(bkajdryvco) = vstgspotbi trlnxmozrf (pllgygbqcc, wudagipbhf - zuqpaunpoq) View more	-	23 Jul 2015
				Normal Saline (Normal Slaline)	iibyjiwkth(bkajdryvco) = skuhcoydlh trlnxmozrf (pllgygbqcc, zgrgubkwuf - mbbchoniye) View more
NCT01730326 (Pubmed \| Emerg Med J)	Phase 4	Acute migraine	200	Intravenous paracetamol	ryptnxflfh(euoelymgpi) = nimgoyzaci ztrqjmemqm (dithvnjmur, 30 - 78.5)	-	01 Mar 2014
				Dexketoprofen	ryptnxflfh(euoelymgpi) = ugvdeloysc ztrqjmemqm (dithvnjmur, 34 - 75)