[Translation] A randomized, open-label, two-period, double-crossover bioequivalence study of eslicarbazepine acetate tablets in healthy subjects under fasting and fed conditions

研究空腹或餐后状态下，单次口服醋酸艾司利卡西平片受试制剂(规格：400mg，生产商：扬子江药业集团有限公司，提供商：扬子江药业集团北京海燕药业有限公司）与参比制剂（Aptiom®，规格：400mg，持证商：Sunovion Pharmaceuticals Inc. ）在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

To study the pharmacokinetic behavior of the test preparation of eslicarbazepine acetate tablets (specification: 400 mg, manufacturer: Yangtze River Pharmaceutical Group Co., Ltd., provider: Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd.) and the reference preparation (Aptiom®, specification: 400 mg, licensee: Sunovion Pharmaceuticals Inc.) in healthy subjects after a single oral administration in the fasting or postprandial state, and to evaluate the bioequivalence of the two preparations. To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date08 Jun 2020

Sponsor / Collaborator

Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd.

NCT04095182 / CompletedPhase 1

A Dose Randomized, Double-blind, Placebo Controlled, Single and Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of Zebinix (Eslicarbazepine Acetate) After Oral Administration in Healthy Korean and Caucasian Adult Subjects

A dose randomized, double-blind, placebo controlled, single and multiple dosing, dose-escalation phase I clinical trial to investigate the safety, tolerability and pharmacokinetic characteristics of Zebinix (Eslicarbazepine acetate) after oral administration in healthy Korean and Caucasian adult subjects

Start Date22 Aug 2019

Sponsor / Collaborator

Whan In Pharmaceutical Co., Ltd.

EUCTR2018-002747-29-SE / Not yet recruitingPhase 2

Prevention of epilepsy in stroke patients at high risk of developing unprovoked seizures: anti-epileptogenic effects of eslicarbazepine acetate

Start Date05 Jun 2019

Sponsor / Collaborator

BIAL-Portela & Cia SA

100 Clinical Results associated with Eslicarbazepine Acetate

100 Translational Medicine associated with Eslicarbazepine Acetate

100 Patents (Medical) associated with Eslicarbazepine Acetate

569

Literatures (Medical) associated with Eslicarbazepine Acetate

01 Jan 2025·JOURNAL OF CHILD NEUROLOGY

The Initial Experience of Eslicarbazepine in Children at Three Canadian Tertiary Pediatric Care Centers

Article

Author: Nyakeri, Yvonne ; Datta, Anita N. ; Haile, Denait ; Nouri, Maryam ; Xu, Qi

Introduction:

Eslicarbazepine (ESL) is a once-daily, third-generation antiseizure medication for focal-onset seizures. The primary mechanism of action is enhancing the slow inactivation of voltage-gated sodium channels. The study objective was to review real-world experience regarding retention rate, efficacy, and tolerability of eslicarbazepine, soon after it became available for children in Canada.

Methods:

A retrospective review was performed on all patients prescribed eslicarbazepine from September 2017 to June 2020, with at least 3 years of follow-up data, at 3 Canadian tertiary care pediatric centers.

Results:

Fifty patients were identified, and the mean age of eslicarbazepine initiation was 12.4 years (range 3-19 years). Most patients had drug-resistant epilepsy, trying a mean of 5.04 (range 0-14) antiseizure medications before the initiation of eslicarbazepine. Twenty-four patients (48.0%) experienced adverse effects, including dizziness (n = 10), drowsiness (n = 6), dizziness and drowsiness (n = 1), nausea and abdominal pain (n = 4), transient unsteadiness and diplopia (n = 1), and negative mood changes (n = 2). None had serious adverse effects, including rash. The retention rate of eslicarbazepine at last follow-up was 70%. Fifteen (30%) had ≥50% seizure reduction, with 2 of these patients becoming seizure free. Ten (20%) had 25% to 50% reduction, 2 (4%) had worsening of seizures, and 17 (34%) had no change in seizure frequency.

Conclusion:

The study results support the long-term effectiveness and tolerability of eslicarbazepine in a cohort of children with predominantly drug-resistant epilepsy in a real-life setting from 3 Canadian centers with initial use after approval. Adverse effects were nonserious, infrequently leading to eslicarbazepine discontinuation.

01 Dec 2024·SEIZURE-EUROPEAN JOURNAL OF EPILEPSY

Exploration of the potential association between newer antiseizure medications and arrhythmias: Integrating pharmacovigilance and bioinformatics evidence

Article

Author: Wu, Xuemei ; Chen, Zhenhui ; Shen, Yun ; Ye, Yanrong ; Zhou, Jianxing ; Zhang, Mengjun

INTRODUCTION:

Arrhythmias resulting from newer antiseizure medications (ASMs) may significantly impact the safety and quality of life of patients with epilepsy. This study investigated the potential association between new first-line or second-line ASMs and arrhythmias.

METHODS:

Pharmacovigilance analysis was conducted using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) from 2004 to 2023. A disproportionality analysis was performed to compare newer ASMs with other drugs, using carbamazepine and valproate as positive controls. Newer ASMs were categorized into sodium channel (SCN) main mechanism, SCN possible mechanism, and non-SCN group. The bioinformatics analysis involved retrieving therapeutic gene targets for ASMs from the DrugBank and OMIM databases, as well as identifying arrhythmia disease targets from the GeneCards database. Additionally, enrichment analysis of gene ontology functions and KEGG pathways was conducted.

RESULTS:

A total of 3,457 cases of arrhythmias associated with newer ASMs were identified in the FAERS database. Disproportionality analysis indicates that brivaracetam (IC025 = 0.08), zonisamide (IC025 = 0.13), eslicarbazepine (IC025 = 0.39), and lacosamide (IC025 = 0.84) exhibited a positive signal for arrhythmias, with signals predominantly observed in the SCN main mechanism group. Furthermore, bioinformatics analysis revealed the involvement of adrenergic signaling in cardiac myocytes, as well as the participation of sodium channel genes in ASM-induced arrhythmias.

CONCLUSION:

Our findings suggest a potential association between SCN-ASMs and arrhythmias, highlighting the importance of monitoring and evaluating the safety profiles of newer ASMs in clinical practice. Further research is necessary to elucidate the underlying mechanisms and inform patient care strategies.

01 Oct 2024·PFLUGERS ARCHIV-EUROPEAN JOURNAL OF PHYSIOLOGY

Persistent sodium currents in neurons: potential mechanisms and pharmacological blockers

Review

Author: Müller, Peter ; Egorov, Alexei V ; Draguhn, Andreas

Abstract:

Persistent sodium current (INaP) is an important activity-dependent regulator of neuronal excitability. It is involved in a variety of physiological and pathological processes, including pacemaking, prolongation of sensory potentials, neuronal injury, chronic pain and diseases such as epilepsy and amyotrophic lateral sclerosis. Despite its importance, neither the molecular basis nor the regulation of INaP are sufficiently understood. Of particular significance is a solid knowledge and widely accepted consensus about pharmacological tools for analysing the function of INaP and for developing new therapeutic strategies. However, the literature on INaP is heterogeneous, with varying definitions and methodologies used across studies. To address these issues, we provide a systematic review of the current state of knowledge on INaP, with focus on mechanisms and effects of this current in the central nervous system. We provide an overview of the specificity and efficacy of the most widely used INaP blockers: amiodarone, cannabidiol, carbamazepine, cenobamate, eslicarbazepine, ethosuximide, gabapentin, GS967, lacosamide, lamotrigine, lidocaine, NBI-921352, oxcarbazepine, phenytoine, PRAX-562, propofol, ranolazine, riluzole, rufinamide, topiramate, valproaic acid and zonisamide. We conclude that there is strong variance in the pharmacological effects of these drugs, and in the available information. At present, GS967 and riluzole can be regarded bona fide INaP blockers, while phenytoin and lacosamide are blockers that only act on the slowly inactivating component of sodium currents.

News (Medical) associated with Eslicarbazepine Acetate

10 Jul 2023

·www.biospace.com

Sumitomo Pharma America Launches as New Combined Organization with Expanded Scale, Resources & Capabilities

CAMBRIDGE, Mass., July 10, 2023 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA), as previously announced on April 3, 2023, is pleased to share it has successfully launched its operations in the U.S. and related markets. The newly combined company is focused on addressing unmet patient needs in critical disease areas across psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. SMPA's diverse portfolio includes six marketed products and a robust pipeline of early- to late-stage assets, with topline data for two of its Phase 3 candidates in the fields of psychiatry and urology expected this quarter. The company will apply its proprietary advanced analytics and computational technology platforms to support and accelerate its diverse pipeline and commercial programs as well as needed innovations in priority areas of discovery, science, research and development. SMPA's President and Chief Executive Officer, Myrtle Potter, Chief Executive Officer of Biopharma, Adele Gulfo, and Chief Medical Officer, Armin Szegedi, were appointed as Executive Officers of Sumitomo Pharma Co., Ltd. effective July 1, 2023. Innovation Growth Engine "We are pleased to have successfully completed the combination of Sumitomo Pharma's U.S. subsidiaries to form SMPA," said Hiroshi Nomura, Representative Director, President and Chief Executive Officer of Sumitomo Pharma. "As a Sumitomo Pharma Group growth engine, SMPA will focus on maximizing the value of the three key products early, namely, ORGOVYX®, MYFEMBREE®, and GEMTESA®. SMPA will propel scientific and therapeutic innovations to meaningfully impact the evolving health needs of patients in North America and promote development to meet the needs of patients worldwide while also delivering long-term value to society as a stronger, more profitable enterprise." "SMPA comprises some of the brightest talent in drug development, business, science, and technology, operating as one global team to push beyond industry norms and reimagine what's possible," said Myrtle Potter, President and Chief Executive Officer, Sumitomo Pharma America. "Our goal is to realize new treatments with greater benefit to patients while maximizing the potential of our key marketed and development assets to better support areas of critical need and provide potential treatment options where solutions are lacking or do not exist." Commercial Biopharma Business Adele Gulfo, Chief Executive Officer of Biopharma Commercial of Sumitomo Pharma America, said, "SMPA is poised to help solve health challenges in critical disease areas through the exceptional talents and dedication of our highly experienced cross-functional team. SMPA's broad product portfolio, including key brands, ORGOVYX®, MYFEMBREE® and GEMTESA®, will drive the growth of our business and fuel future potential investments. We are deeply committed to the patients we serve in oncology, women's health, urology, rare disease, psychiatry, and neurology, as well as our additional products APTIOM®, RETHYMIC®, and LATUDA®, which healthcare providers and patients continue to rely on." R&D & Pipeline Armin Szegedi, Chief Medical Officer of Sumitomo Pharma America, said, "SMPA has a robust and balanced pipeline, with more than 30 assets and dozens of clinical trials currently underway, to address areas of significant need in psychiatry, neurology, oncology, urology, and regenerative medicine. I am excited about the opportunities we have at SMPA to develop innovative treatments across multiple therapeutic indications, including our lead pipeline candidate, ulotaront, which is being studied in individuals living with schizophrenia, generalized anxiety disorder and the adjunctive treatment of major depressive disorder." Jatin Shah, Chief Oncology Development Officer of Sumitomo Pharma America, added, "SMPA is uniquely positioned with a strong internal discovery and translational research engine committed to the identification and development of innovative, best-in-class, oncology therapies. We are also looking forward to quickly advancing our oncology programs including, TP-3654, an investigational selective oral PIM1 kinase inhibitor, being studied for patients with myelofibrosis (MF) and DSP-5336, an investigational small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein, being evaluated for the treatment of acute myeloid leukemia (AML)." SMPA's leadership team comprises industry-leading experts with deep life sciences expertise across the business and drug development spectrum, as well as quality & manufacturing, commercialization, and data & analytics. We invite you to learn about SMPA's full leadership team and capabilities on our new website: . About Sumitomo Pharma America, Inc. Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. The company's diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. SMPA leverages proprietary in-house advanced analytics and computational technology platforms to accelerate discovery, research, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma Co., Ltd., company. For more information on SMPA, visit our website or follow us on LinkedIn. About Sumitomo Pharma Co., Ltd. Sumitomo Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries with more than 6,000 employees worldwide. Sumitomo Pharma defines its Mission as "To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide." Additional information about Sumitomo Pharma is available through its corporate website at . Forward-Looking Statements This press release contains forward-looking statements that may be deemed to be "forward-looking statements" within the meaning of applicable securities laws and Sumitomo Pharma America, Inc. may make related oral, forward-looking statements on or following the date hereof. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Forward-looking statements, by their nature, are subject to a variety of inherent risks and uncertainties that could cause actual results to differ materially from the results projected and reported results should not be considered as an indication of future performance. Many of these risks and uncertainties cannot be controlled by Sumitomo Pharma America, Inc. and you should not place undue reliance on any forward-looking statements. These forward-looking statements are based on information available to Sumitomo Pharma America, Inc. as of the date of this communication and speak only as of the date of this communication. Sumitomo Pharma America, Inc. does not assume any obligation to publicly update any forward-looking statements, except as may be required by law. No information contained on any website referenced in this press release is incorporated by reference herein. Sumitomo Pharma America, Inc. is a registered trademark of Sumitomo Pharma Co., Ltd. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. © 2023 Sumitomo Pharma America, Inc. All rights reserved. SMPA IR / Media Contact: Maya Frutiger VP, Head of Corporate Communications Sumitomo Pharma America, Inc. CorpComms@us.sumitomo-pharma.com View original content to download multimedia: SOURCE Sumitomo Pharma America, Inc.

Executive ChangePhase 3

20 Feb 2009

·www.pharmatimes.com

EMEA calls for Raptiva suspension, issues latest recommendations

On a busy day for the regulator, the European Medicines Agency has recommended that marketing authorisation be suspended for Merck KGaA/Genentech's psoriasis drug Raptiva over possible links between the drug and a rare but deadly brain infection. The EMEA’s Committee for Medicinal Products for Human Use (CHMP) said the benefits of Raptiva (efalizumab) no longer outweigh its risks, because of safety concerns, notably the occurrence of progressive multifocal leukoencephalopathy (PML) in patients taking the medicine. The CHMP noted three confirmed cases of PML in patients who had taken Raptiva for more than three years, two of resulted in the patient’s death, and the agency has received an additional report of a suspected case of PML, “which could not be confirmed”. Nevertheless, following a review, the CHMP has concluded that “Raptiva’s benefits are modest”. In addition to PML, Raptiva is associated with other serious side effects, including Guillain-Barre and Miller-Fisher syndromes, encephalitis, encephalopathy, meningitis, sepsis and opportunistic infections,” the EMEA noted. It added that “there is not enough evidence to identify a group of patients in which the benefits of Raptiva outweigh its risks”. The EMEA’s call for suspension came as its counterpart in the USA, the Food and Drug Administration, issued a public health advisory about the three confirmed reports of PML and the possible fourth case. The FDA stated that it will “take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits”. Merck, which markets Raptiva in Europe, said it would work with health authorities across the continent "to undertake all necessary measures to comply with the EMEA recommendations." Earlier this week, the Darmstadt-based group noted that it had written off 195 million euros due to “sharply lower sales expectations” for the drug. Staying with the EMEA, the agency has issued the latest list of positive opinions from the CHMP. The drugs recommended for approval include Wyeth’s Conbriza (bazedoxifene) for postmenopausal osteoporosis, Bial’s anti-epileptic Zebinix (eslicarbazepine; see story on today’s elert) and Fresenius’ Removab (catumaxomab) for the removal of cancerous fluid from the abdomen. The CHMP is also recommending approval for Nycomed’s over-the-counter versions of its own heartburn drug Pantozol (pantoprazole) and Teva’s generic version of Novartis’ anti-dementia drug Exelon (rivastigmine). However, it adopted a negative opinion for Biferonex (interferon-beta-1a), from Switzerland’s BioPartners, for multiple sclerosis. BioPartners is appealing the decsion, claiming that Biferonex demonstrated safety and efficacy profiles comparable to established interferon beta-1a products already on the market".

100 Deals associated with Eslicarbazepine Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D09612	Eslicarbazepine Acetate	N03AF04	DB09119

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Epilepsy	KR	Whan In Pharmaceutical Co., Ltd.	10 Nov 2020
Epilepsies, Partial	EU	BIAL-Portela & Cia SA	21 Apr 2009
Epilepsies, Partial	IS	BIAL-Portela & Cia SA	21 Apr 2009
Epilepsies, Partial	LI	BIAL-Portela & Cia SA	21 Apr 2009
Epilepsies, Partial	NO	BIAL-Portela & Cia SA	21 Apr 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diabetic peripheral neuropathic pain	Phase 3	PT	BIAL-Portela & Cia SA	01 Nov 2010
Neuralgia, Postherpetic	Phase 3	DE	BIAL-Portela & Cia SA	01 Sep 2010
Seizures	Phase 3	PT	BIAL-Portela & Cia SA	01 Jul 2004
Stroke	Phase 2	AT	BIAL-Portela & Cia SA	29 May 2019
Stroke	Phase 2	FR	BIAL-Portela & Cia SA	29 May 2019
Stroke	Phase 2	DE	BIAL-Portela & Cia SA	29 May 2019
Stroke	Phase 2	IL	BIAL-Portela & Cia SA	29 May 2019
Stroke	Phase 2	IT	BIAL-Portela & Cia SA	29 May 2019
Stroke	Phase 2	PT	BIAL-Portela & Cia SA	29 May 2019
Stroke	Phase 2	ES	BIAL-Portela & Cia SA	29 May 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


IEC2023	Not Applicable	Behavioural disorders	849	Eslicarbazepine Acetate	nmvwspikfx(rcwaebanld) = 43 reports avbtpdjyno (bzkkctwdtk ) View more	-	04 Sep 2023
P4-1.010 (AAN2023)	Not Applicable	Seizures	-	Eslicarbazepine Acetate 400mg/day	ihbjabwnpf(nfugwvxuuc) = fhdxoixqas pyzxhpkohu (zpnynatkkq, 8.6)	Positive	25 Apr 2023
				Eslicarbazepine Acetate 800mg/day	ihbjabwnpf(nfugwvxuuc) = yyncqisjbv pyzxhpkohu (zpnynatkkq, 6.2)
P14-1.003 (AAN2023)	Phase 3	Seizures	1,447	Eslicarbazepine Acetate 800mg	hkwkcrmcpa(lttwmawqzs) = Incidence of AEs and AEs leading to discontinuation increased with ESL dose ziymwkqcqo (uvggyitfqs ) View more	Positive	25 Apr 2023
				Eslicarbazepine Acetate 1200mg
NCT02484001 (NCT01162460/NCT02484001; EudraCT 2009-011135-13/2015-001243-36, Pubmed \| Ther Adv Neurol Disord)	Phase 3	Seizures plasma lipid levels \| total cholesterol \| low-density lipoprotein (LDL) cholesterol	184	Eslicarbazepine acetate (ESL)	tpikkxhnnw(ncjewcsqez) = nqbzlzrzby devccuvjnr (ofshqdcgbt ) View more	Positive	01 Jan 2023
				Controlled-release carbamazepine (CBZ-CR)	tpikkxhnnw(ncjewcsqez) = fotobzywzu devccuvjnr (ofshqdcgbt ) View more
BIA-2093-208 \| BIA-2093-305 (EAN2022)	Phase 2/3	Seizures	-	Eslicarbazepine acetate	sxtaloywaa(dgmgvgdblt) = bjuttspvhp weureggmnu (axdmomrzek ) View more	Positive	24 Jun 2022
				Placebo	sxtaloywaa(dgmgvgdblt) = eynrizopxp weureggmnu (axdmomrzek ) View more
BIA-2093-304 (EAN2021)	Not Applicable	-	496	Eslicarbazepine acetate 800mg/day	posiozpdgv(oweawygzdn) = 7.5% in Part II and not reported in Part III pzrjqwvzko (stjglogbqa ) View more	Positive	18 Jun 2021
				Eslicarbazepine acetate 400-1600mg/day
EAN	Not Applicable	Pregnancy	3,986	Eslicarbazepine acetate	uifwtgibpc(kyarpgssnr) = abuwyvwiux iunfpmlmme (wudfetpdes ) View more	Positive	18 Jun 2021
NCT00957047 \| NCT00957684 \| NCT00988429 (Pubmed \| Epilepsy Res)	Phase 3	Epilepsies, Partial \| Seizures	-	eslicarbazepine acetate (Older adults (≥60 years))	sutoymxfie(ycbiykysjn) = adyzmnasbd htncejkkgg (asnhjdhbid ) View more	-	01 Jan 2021
				eslicarbazepine acetate (Younger adults (18-59 years))	sutoymxfie(ycbiykysjn) = yraygttucq htncejkkgg (asnhjdhbid ) View more
NCT02484001 (Pubmed) Manual	Phase 3	Epilepsies, Partial	184	eslicarbazepine acetate (ESL/ESL)	rkgbtccdjs(oscufqhflr) = plwsanoxhs fmpdshcduo (sxbuyfvgjj, 0.0292 - 0.1366) View more	Positive	01 Oct 2020
				controlled-release carbamazepine+eslicarbazepine acetate (CBZ-CR/ESL)	rkgbtccdjs(oscufqhflr) = jsqtjdmxfl fmpdshcduo (sxbuyfvgjj, 0.0180 - 0.1210) View more
NCT03116828 (1585, CTgov)	Phase 4	Epilepsies, Partial	102	eslicarbazepine acetate (Eslicarbazepine Acetate (Arm 1))	jbhanjkhrz(dknvvloxzw) = ilijymusro wwafgdqndu (iebvtznuup, xjlcmpqoxc - zndbmwkxjk)	-	16 Jun 2020
				eslicarbazepine acetate (Eslicarbazepine Acetate (Arm 2))	jbhanjkhrz(dknvvloxzw) = zqjehtybfa wwafgdqndu (iebvtznuup, sikxyascao - uppatqqkzd)

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