主要研究目的：研究中国慢性疼痛研究参与者空腹状态下多剂量口服受试制剂盐酸他喷他多缓释片（规格：50mg，宜昌人福药业有限责任公司持证）与参比制剂盐酸他喷他多缓释片（商品名：Palexia Retard，规格：50mg；Grünenthal GmbH持证）后体内的药代动力学，评价空腹状态多剂量口服两种制剂的生物等效性。次要研究目的：评价受试制剂盐酸他喷他多缓释片50mg和参比制剂盐酸他喷他多缓释片（商品名：Palexia Retard ）50mg在中国慢性疼痛研究参与者中多剂量给药的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of the test preparation Tapentadol Hydrochloride Sustained-Release Tablets (Specification: 50 mg, licensed by Yichang Renfu Pharmaceutical Co., Ltd.) and the reference preparation Tapentadol Hydrochloride Sustained-Release Tablets (trade name: Palexia Retard, specification: 50 mg; licensed by Grünenthal GmbH) in the fasting state in Chinese chronic pain study participants, and to evaluate the bioequivalence of the two preparations after multiple oral doses of the two preparations in the fasting state. Secondary purpose of the study is to evaluate the safety of multiple doses of the test preparation Tapentadol Hydrochloride Sustained-Release Tablets 50 mg and the reference preparation Tapentadol Hydrochloride Sustained-Release Tablets (trade name: Palexia Retard) 50 mg in Chinese chronic pain study participants.

Start Date23 Mar 2025

Sponsor / Collaborator

Yichang Humanwell Pharmaceuticals Co., Ltd.

ChiCTR2500097430

/ SuspendedNot ApplicableIIT

Study of human bioequivalence of Tapentadol Hydrochloride Prolonged-Release Tablets

Start Date19 Feb 2025

Sponsor / Collaborator

Second Affiliated Hospital of Guangzhou Medical University

CTR20244800

/ CompletedNot Applicable

盐酸他喷他多缓释片人体生物等效性研究

[Translation] Study on the bioequivalence of tapentadol hydrochloride sustained-release tablets in healthy volunteers

主要研究目的：研究慢性疼痛参与者在空腹和餐后状态下单次口服受试制剂盐酸他喷他多缓释片（规格：100mg，宜昌人福药业有限责任公司生产）与参比制剂盐酸他喷他多缓释片（商品名：PalexiaRetard，规格：100mg；持证商：Grünenthal GmbH）的药代动力学，评价空腹和餐后状态口服两制剂的生物等效性。次要研究目的：研究受试制剂盐酸他喷他多缓释片100mg和参比制剂盐酸他喷他多缓释片（商品名：PalexiaRetard）100mg在慢性疼痛参与者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of the test preparation tapentadol hydrochloride extended-release tablets (specification: 100 mg, produced by Yichang Renfu Pharmaceutical Co., Ltd.) and the reference preparation tapentadol hydrochloride extended-release tablets (trade name: PalexiaRetard, specification: 100 mg; licensee: Grünenthal GmbH) in participants with chronic pain after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary purpose of the study: to study the safety of the test preparation tapentadol hydrochloride extended-release tablets 100 mg and the reference preparation tapentadol hydrochloride extended-release tablets (trade name: PalexiaRetard) 100 mg in participants with chronic pain.

Start Date04 Jan 2025

Sponsor / Collaborator

Yichang Humanwell Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Tapentadol Hydrochloride

100 Translational Medicine associated with Tapentadol Hydrochloride

100 Patents (Medical) associated with Tapentadol Hydrochloride

1,054

Literatures (Medical) associated with Tapentadol Hydrochloride

01 Jul 2025·JOURNAL OF PHARMACEUTICAL SCIENCES

Physiologically based pharmacokinetic modeling of tapentadol in children to support pediatric dose selection

Article

Author: Zheng, Liang ; Yang, Yujie ; Zhang, Wei ; Dallmann, André ; Hu, Wei ; Zhang, Qian ; Wang, Zilong ; Cao, Zhihai

Tapentadol, an effective opioid analgesic, is indicated for the treatment of pain that cannot be managed with non-opioid medications. This study employed a physiologically based pharmacokinetic (PBPK) model to characterize the disposition of tapentadol in children across different age groups and to refine pediatric dosing strategies. Initially, an adult PBPK model was developed using the 'middle-out' strategy, which was then adjusted by scaling anatomical and physiological parameters to apply it to pediatric populations. The model's precision was confirmed by comparing the simulated plasma concentrations in a virtual population with empirical data. Utilizing this model, we translated dosages from adults to children and assessed weight-adjusted dosages for children aged 2 to 18 years and those under 2 years. The ratios of predicted to observed pharmacokinetic (PK) parameters for adult tapentadol ranged from 0.80 to 1.40 with the pediatric population's predictive mean absolute prediction error (MAPE) being less than 0.45. Based on model validation, we have established the following fixed-dose regimen for tapentadol oral solution for children across various age groups: 2.5 mg for 0-1 month, 3.5 mg for 1-3 months, 5 mg for 3-6 months, 8.5 mg for 6 months to 1 year, 13 mg for 1-2 years, 20 mg for 2-6 years, 35 mg for 6-12 years, and 60 mg for 12-18 years. The results of this study may offer guidance for the clinical investigation of tapentadol in pediatric patients and for developing PBPK models for drugs undergoing multiple metabolic pathways.

01 Jun 2025·Pain Management Nursing

Pharmacological Treatment of Chemotherapy-Induced Neuropathy: A Systematic Review of Randomized Clinical Trials

Review

Author: Souza, Anna Karla do Nascimento ; Kraychete, Durval Campos ; Azi, Liana Maria Torres de Araujo ; Lins-Kusterer, Liliane Elze Falcão ; Jesus Palma, Ana Carolina de ; Barreto, Eduardo Silva Reis ; Mathias, Clarissa Maria de Cerqueira ; Antunes Júnior, César Romero ; Alencar, Vinicius Borges

PURPOSE:

Chemotherapy-induced peripheral neuropathy (CIPN) affects up to 80% of patients undergoing cytotoxic chemotherapy. This painful condition significantly impairs quality of life and often necessitates dose reduction or discontinuation of chemotherapy, negatively impacting overall survival. Currently, duloxetine is the only pharmacological treatment recommended by the American Society of Clinical Oncology (ASCO). This systematic review aims to evaluate the efficacy of various pharmacological interventions in CIPN treatment, providing substantial evidence for clinical practice and future research.

DESIGN:

This systematic review was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to assess the effectiveness of pharmacological treatments for CIPN.

METHODS:

Only randomized controlled trials (RCTs) were included. Herbal and phytotherapeutic treatments were excluded. Two independent reviewers performed the study selection, with a third reviewer resolving disagreements. Risk of bias assessment was conducted using the COCHRANE's RoB 2 tool.

RESULTS:

Out of 860 screened articles, 17 RCTs met the inclusion criteria, encompassing 15 different pharmacological agents. Duloxetine, pregabalin, and amitriptyline were the most studied. Thirteen studies utilized a placebo as a control. Investigated medications exhibited varied outcomes, with some showing significant benefits in reducing neuropathic pain while others did not demonstrate statistically significant efficacy.

CONCLUSION:

Duloxetine is an effective and well-tolerated option, while pregabalin shows promising results but requires further investigation. Other agents, such as venlafaxine and tapentadol, lack strong supporting evidence. Treatments like acetyl-l-carnitine, monosialotetrahexo-sylganglioside 1, and tetrodoxine yield inconsistent results, highlighting the need for additional research. Larger RCTs are recommended for comprehensive evaluation. Nurses are essential in CIPN care by monitoring symptoms, educating patients, and collaborating with the team.

11 Apr 2025·ACS Pharmacology & Translational Science

Revealing Pharmacokinetic Interactions of Tramadol, Tapentadol, and Venlafaxine: A Cutting-Edge Liquid Chromatography–Tandem Mass Spectrometry Analytical Approach in Rat Plasma

Article

Author: Elgawish, Mohamed Saleh ; Darwish, Khaled M. ; Mostafa, Samia M. ; Heneedak, Hala M.

The detection and quantification of opioid analgesics adulterated with serotonin reuptake inhibitors are critical in forensic toxicology due to their significant clinical and legal implications. This study focuses on developing and validating a highly sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the simultaneous quantification of tramadol (TMD), tapentadol (TAP), and venlafaxine (VEN) in small volumes of rat plasma. The method employs a straightforward single-step protein precipitation technique for sample pretreatment. Utilizing a Shim-pack Velox SP-C18 column (2.7 μm, 2.1 × 150 mm, Shimadzu, Japan), a 12 min gradient elution was performed with a mobile phase of 0.1% formic acid in water (solvent A) and acetonitrile (solvent B). Detection and quantification were achieved in multiple-reaction-monitoring mode, with ion transitions of m/z 264.3 → 58.1 for TMD, m/z 222.3 → 107.1 for TAP, m/z 278.2 → 58.2 for VEN, and m/z 195.5 → 138.1 for caffeine, which served as the internal standard (IS). The method exhibited excellent linearity, with concentration ranges of 1-500 ng/mL for TMD (r ² = 0.9981), 1-1000 ng/mL for TAP (r ² = 0.9972), and 1-900 ng/mL for VEN (r ² = 0.9987) in rat plasma using only 50 μL of sample. This validated method was applied to a pharmacokinetic interaction study, revealing significant drug interactions: the maximum observed plasma concentration (C _max) and area under the curve (AUC) for both TMD and VEN decreased. For TMD, C _max decreased by 2.58-fold from 276.25 to 106.99, and AUC_0-t decreased by 1.4-fold from 3005.8 to 2159.3. For VEN, C _max decreased by 2.51-fold from 494 to 191, and AUC_0-t decreased by 2.3-fold from 4988 to 2114. However, for TAP, C _max increased by 3.4-fold from 138.54 to 471.85, and AUC_0-t increased by 2.66-fold from 1060.1 to 2826.8. The concurrent administration likely creates metabolic competition at CYP2D6 and UDP glycosyltransferase enzyme sites, affecting the pharmacokinetic parameters. These findings underscore the importance of further studies to monitor the simultaneous presence of these drugs and their metabolites in plasma, especially when coadministration occurs unintentionally.

News (Medical) associated with Tapentadol Hydrochloride

17 May 2025

·pharma.economictimes.indiatimes.com

Small Drugmakers Oppose CDSCO Export NOC Rules; Seek Schedule M Extension Till 2026

New Delhi: Small pharmaceutical firms in India have raised strong objections to new guidelines issued by the Central Drugs Standard Control Organisation (CDSCO) regarding the issuance of No Objection Certificates (NOC) for exporting both approved and unapproved new drugs. In a letter to Union Minister of Chemicals and Fertilizers JP Nadda, the RSS-affiliated Laghu Udyog Bharati (LUB)—a body representing small-scale industries—stated that it would be difficult for MSME units to comply with the new export NOC procedures. The letter reads: “Due to the wrongdoings of a few companies, genuine pharma exporters should not be penalized. It will be difficult for an MSME unit to meet the conditions of the new export NOC procedure.” “Due to this NOC hurdle, neighboring countries will capture the export market, and that will be a permanent dent to Indian pharma exports. We have a few suggestions to ease this process without compromising ‘Brand Bharat’,” it added. On March 7, 2025, CDSCO issued a “guidance document for issuance of no objection certificate for manufacture of unapproved/approved new drugs for export purpose.” Notably, LUB raised concerns about the initial version of the document. Earlier this month, CDSCO released a revised version with several amendments. A major concern cited by industry stakeholders is the requirement for approval from the National Regulatory Authority (NRA) of the importing country. According to the guidance, manufacturers must obtain such approval. If a product (either API or formulation) is already registered and approved by the NRA for a specific firm, that approval may be considered applicable to other applicants. The revision to the export process was made in the wake of a BBC report that linked a Mumbai-based drug manufacturer, Aveo Pharma, to the West African opioid crisis. As per the report the company allegedly manufactured and illegally exported two unapproved drugs—Tapentadol and Carisoprodol—implicated in a public health crisis involving opioid addiction in Nigeria and Ghana. Meanwhile, in its letter, LUB also reiterated its longstanding demand for the establishment of a Drug Tribunal Board to oversee prosecution matters involving various state authorities and CDSCO. The organisation noted that the previous minister had instructed the Secretary of the Department of Pharmaceuticals to create a roadmap for such a tribunal, similar to those established under FSSAI, GST, and Income Tax laws, which help resolve issues more efficiently and leave only serious offences to be addressed in judicial courts. LUB also urged that no risk-based inspections be conducted until the notified deadline of December 31, 2025, for implementing revised Schedule M requirements. Furthermore, it requested that manufacturers with an annual turnover below ₹50 crore be granted a one-year extension to comply with Schedule M norms—pushing their deadline to December 31, 2026. Under the Drugs and Cosmetics Rules, 1945, Schedule M outlines Good Manufacturing Practices (GMP) that all pharmaceutical manufacturers in India must follow. These regulations cover facility premises, equipment, plant operations, and quality assurance processes to ensure that drugs are consistently produced to meet specified quality standards. In December 2023, the Ministry of Health and Family Welfare had notified revised Schedule M requirements. Small manufacturers with a turnover of less than ₹250 crore were granted a compliance extension until December 31, 2025. By Online Bureau ,

07 May 2025

·pharma.economictimes.indiatimes.com

CDSCO revises guidelines for obtaining Export NOC, drops contentions provision

New Delhi: Exactly two months after issuing guidelines for obtaining NOC to export approved and unapproved drugs, the Central Drugs Standard Control Organization (CDSCO) has issued a revised document dropping the earlier notified requirement of unique registration in the importing country. The initial guidance document issued by the apex regulatory body on March 7 had mandated that firms seeking export NOC had to submit approval status of the applied Drug (s) as issued by the National Regulatory Authority (NRA) of the Importing country. Whereas the revised document issued by the body states that if the product is registered and approved by the NRA for a specific firm, such approval may be considered applicable for other applicants. “The firm needs to submit approval status of the applied Drug (s) as issued by the NRA of Importing country. In case NRA approval is not applicable, then approval status of India may be submitted,” the initial document reads. However the revised version suggests that, “in case the pharmaceutical product (API or formulation) has been registered and approved by the National Regulatory Authority (NRA) of the destination country for a specific firm, such approval may be considered applicable for other applicants.” Notably, the revision has been made following the objections raised by the government backed export promotion body Pharmexcil. As per a media report in a letter addressed to the Drugs Controller General of India (DCGI), the industry body was concerned that the amendment will “significantly strain India's pharmaceutical export sector and sought a review of the then new rule. The revision was made following a controversy based on a BBC report which suggested the alleged involvement of a Mumbai-based drug maker Aveo Pharma in the West African opioid crisis. The company was charged with manufacturing and illegally exporting two unapproved drugs—Tapentadol and Carisoprodol—which have been linked to a serious public health crisis of opioid addiction in countries such as Nigeria and Ghana While issuing the guidance in March the body in it notice issued from the office of the DCGI had noted that to ensure “ease of doing business” CDSCO has streamlined the process of issuing export NOC for unapproved / approved new drugs through Sugam portal and To reduce the compliance burden, CDSCO has initiated the issue of a 1-year NOC, subject to prescribed conditions for such Drugs, it added. Under the new provisions manufacturers are required to fill an online Integrated Registration Form (IRF) one time before the grant of Export NOC which is valid for 1 year. Earlier, exporters had to obtain a separate, consignment-specific NOC for each export order whereas under the new rules companies can obtain a blanket NOC valid for one year, provided the drug is approved in the importing country and the company has a history of exporting that drug over the past year. Besides this the body has also overhauled the approval process, replacing the state-level clearances to a fully digital system administered through its SUGAM portal. As per the notified draft companies have to register themselves with zonal by filling the one-time Integrated Registration Form (IRF). The IRF will be verified by the concerned zonal office & NOC may be issued with 1year validity for the applied products within 7 working days from the date of Application, the guidelines suggest. By Online Bureau ,

Accelerated ApprovalNDA

02 May 2025

·pharma.economictimes.indiatimes.com

Opioid Tapentadol may be put under Narcotics Act to curb its access

New Delhi: The government is considering bringing the controversial opioid Tapentadol under the Narcotic Drugs and Psychotropic Substances (NDPS) Act following allegations of unbridled exports of the drug to West African nations causing an opioid addiction crisis there. The move is expected to substantially reduce Tapentadol's availability through tight regulation, including oversight on its movement by the Narcotics Control Bureau (NCB) and police. Tapentadol is used for management of pain and is reserved for patients who have limited alternative treatment options. In February, the Drugs Controller General of India prohibited the production and export of all combinations of Tapentadol to West African countries. The ministry of health is likely to take it up with the Department of Revenue to schedule Tapentadol as a psychotropic substance under the NDPS Act in light of its misuse and intoxication, according to a document accessed by ET. The finance ministry regulates certain sections of the Act like categorisation of pharma drugs as narcotics. At present, Tapentadol is not scheduled under the Act. A proposal was earlier placed before the Drugs Consultative Committee (DCC), an advisory body on drugs, to put Tapentadol under Schedule X of the Drugs and Cosmetics Act. Schedule X lists habit-forming narcotic and psychotropic substances, requiring licences for their import, manufacture, distribution and sale. However, it was concluded that putting Tapentadol in Schedule X may restrict its availability as it is a widely used medicine, and therefore, the issue needed further deliberation. A sub-committee comprising a regulator from the drug regulatory authority, one from state regulators, a clinician (psychiatrist) and a pharmacologist was formed for examining the matter in respect of the controversial drug. The sub-committee concluded that the drug be retained in Schedule H1, as putting it in Schedule X will restrict its availability. Schedule H1 is a category under the Drugs and Cosmetics Rules of 1945 that lists specific drugs primarily antibiotics, anti TB drugs and certain psychotropic medications that require stringent control and monitoring due to the risk of misuse. The sub-committee in its report also recommended that the Department of Revenue should be asked to schedule Tapentadol as a psychotropic substance under the NDPS Act, similar to Tramadol , another drug that was known to be abused. By Teena Thacker ,

NDA

100 Deals associated with Tapentadol Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D10199	Tapentadol Hydrochloride	N02AX06	DB06204

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Cancer Pain	Japan	Janssen Pharmaceutical KK	01 Aug 2014
Neuralgia	United States	Collegium Pharmaceutical, Inc.	28 Aug 2012
Chronic Pain	United States	Collegium Pharmaceutical, Inc.	25 Aug 2011
Pain	Australia	Seqirus Pty Ltd.	22 Nov 2010
Acute Pain	United States	Collegium Pharmaceutical, Inc.	20 Nov 2008

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Nociceptive Pain	Phase 3	Belgium	Grünenthal GmbH	30 Oct 2009
Nociceptive Pain	Phase 3	Czechia	Grünenthal GmbH	30 Oct 2009
Nociceptive Pain	Phase 3	France	Grünenthal GmbH	30 Oct 2009
Nociceptive Pain	Phase 3	Germany	Grünenthal GmbH	30 Oct 2009
Nociceptive Pain	Phase 3	Netherlands	Grünenthal GmbH	30 Oct 2009
Nociceptive Pain	Phase 3	Poland	Grünenthal GmbH	30 Oct 2009
Nociceptive Pain	Phase 3	Spain	Grünenthal GmbH	30 Oct 2009
Nociceptive Pain	Phase 3	Switzerland	Grünenthal GmbH	30 Oct 2009
Acute low back pain	Phase 3	United States	Grünenthal GmbH	01 Sep 2009
Constipation	Phase 3	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Oct 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01458015 (CTgov)	Phase 4	Neuralgia	3	oxycodone+tapentadol (Oxycodone)	arwvyrdoui(xbbzujnfbf) = ywbqtywztu bxbgzkfvkp (kbvyphsikf, heziwppgvl - jaatloycwy) View more	-	17 Dec 2024
				oxycodone+tapentadol (Tapentadol)	arwvyrdoui(xbbzujnfbf) = lepzumybsp bxbgzkfvkp (kbvyphsikf, wcbuuxnghc - ryqdghrlii) View more
WCO_IOF_ESCEO2020	Not Applicable	Spinal Fractures	19	Tapentadol 50 mg	axcadtmnqy(pzbgoivuzt) = oekjjcandu peuwwivexe (nliybksehf, 10.6)	Positive	20 Aug 2020
EULAR2019	Not Applicable	Respiratory Diseases	29	Tapentadol (Pathological group)	vvuoaygrgt(zkmudowena) = hsgnrramee ovdbpdhgic (eewifehwmz )	Positive	12 Jun 2019
ESMO_ASIA2018	Not Applicable	Head and Neck Neoplasms	60	Tapentadol	ktskhtkvuh(iariskiajt) = 5 patients did not tolerate due to emesis and sedation, in spite of good pain relief; these 5 patients were switched to morphine 10mg 4th hourly. tdihevzigl (finjzsmhzb ) View more	Positive	24 Nov 2018
				Tramadol+Paracetamol+Antiemetics
NCT02221674 (CTgov)	Phase 2	Pain, Postoperative	40	IMP (Participants Aged 6 Months to Less Than 2 Years - PK Set)	rxrwftxyoj(ajjgytrnzo) = mefljmqwsj rfqknflhzy (caccjaklyq, 5.21) View more	-	12 Dec 2017
				IMP (Participants Aged 1 Month to Less Than 6 Months - PK Set)	wcywziqjem(zjvfehxnka) = wxuktmvtmd qrsfxxonbz (nmzefacmfl, 6.30) View more
NCT00472303 (Pubmed \| Eur J Pain)	Phase 3	Cancer Pain	129	Tramadol	yblquhyhar(qqqzahbqat) = ohbogoqvhd agizuhhboa (mfjmawbxyy )	Positive	01 Oct 2016
				Tapentadol PR	yblquhyhar(qqqzahbqat) = lpqywzclwf agizuhhboa (mfjmawbxyy )
NCT01838616 (Pubmed \| Pain Pract) Manual	Phase 3	Low Back Pain	258	Tapentadol	grndrkbvos(ddxjtuqvin) = tapentadol PR was noninferior to oxycodone/naloxone PR pxzwtpgldc (imermfxtav ) View more	Superior	01 Jun 2016
				Oxycodone+Naloxone
NCT00487435 (Pubmed \| Med Lett Drugs Ther \| Clin Ther) Manual	Phase 3	Chronic Pain	1,154	Tapentadol extended release	eupilznzvi(yovswmdwzl) = headache (13.1%), nausea (11.8%), and constipation (11.1%) tppadrzrqq (rudvbzgdog )	Positive	01 Nov 2015
EULAR2015	Not Applicable	Low Back Pain	591	Tapentadol	cqhillqzsv(yohnecrhat) = mbnmbjreai utjnmwhohq (buaglwbupb )	Positive	10 Jun 2015
				Tramadol	cqhillqzsv(yohnecrhat) = vpzleomhfa utjnmwhohq (buaglwbupb )
NCT01838616 (CTgov)	Phase 4	Low Back Pain \| Neuralgia	367	Oxycodone+Naloxone (Oxycodone/Naloxone Prolonged Release)	lausljsglc(rtagyzjoul) = rhurcwvxhu xdnbreaouy (xnsckwgpuq, 0.26) View more	-	08 Jun 2015
				Tapentadol Prolonged Release (Tapentadol Prolonged Release (PR))	mbnqorlrsw(mqlvxtrjor) = vjtmidyurs rzlqruvttn (mguqcqauxk, sxakhrbzuc - zvxdukvgcp) View more

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