A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis (Study OS440-3006)

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets in MS patients with spasticity. Arbaclofen ER will be compared with placebo.

开始日期2026-01-01

申办/合作机构

RVL Pharmaceuticals, Inc.

NCT05617118 / RecruitingN/AIIT

Evaluation of Efficacy and Safety of Oral Baclofen Taking in Comparison With Botulinum Toxin A Injections in Myofascial Pelvic Pain Syndrome. Prospective Multicenter Cohort Study.

The aim of the study is to test the hypothesis that oral taking of baclofen in therapeutic dosage for 60 days is equally effective as injection of botulinum toxin type "A" in the area of trigger points of the pelvic muscles.

开始日期2022-12-01

申办/合作机构

St. Petersburg State University

[+1]

NCT04271332 / Active, not recruiting临床2期IIT

An Exploratory, Randomized, Double-Blind, Placebo-Controlled and Open-label Extension Study of the Safety, Tolerability, and Efficacy of Arbaclofen in Subjects With 16p11.2 Deletion

This Phase 2 study examines the safety, tolerability, and efficacy of arbaclofen in pediatric subjects with 16p11.2 deletion. Male or female subjects aged 5 to 17 years of age will be randomized to receive either placebo or arbaclofen in a double-blind study design. If the subject completes all study requirements through Visit 4 (Close-out Visit), he/she may be eligible for an optional open-label study with arbaclofen.

开始日期2022-09-01

申办/合作机构

Clinical Research Associates, LLC

100 项与 Baclofen Extended Release 相关的临床结果

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100 项与 Baclofen Extended Release 相关的转化医学

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100 项与 Baclofen Extended Release 相关的专利（医药）

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127

项与 Baclofen Extended Release 相关的文献（医药）

2024-07-30·JOURNAL OF ALZHEIMERS DISEASE

Screening Targets and Therapeutic Drugs for Alzheimer’s Disease Based on Deep Learning Model and Molecular Docking

Article

作者: Zhao, Pu ; Li, Jia-Yi ; Zhong, Man-Li ; Gao, Hui-Ling ; Zhang, Ya-Hong

Background: Alzheimer’s disease (AD) is a neurodegenerative disorder caused by a complex interplay of various factors. However, a satisfactory cure for AD remains elusive. Pharmacological interventions based on drug targets are considered the most cost-effective therapeutic strategy. Therefore, it is paramount to search potential drug targets and drugs for AD. Objective: We aimed to provide novel targets and drugs for the treatment of AD employing transcriptomic data of AD and normal control brain tissues from a new perspective. Methods: Our study combined the use of a multi-layer perceptron (MLP) with differential expression analysis, variance assessment and molecular docking to screen targets and drugs for AD. Results: We identified the seven differentially expressed genes (DEGs) with the most significant variation (ANKRD39, CPLX1, FABP3, GABBR2, GNG3, PPM1E, and WDR49) in transcriptomic data from AD brain. A newly built MLP was used to confirm the association between the seven DEGs and AD, establishing these DEGs as potential drug targets. Drug databases and molecular docking results indicated that arbaclofen, baclofen, clozapine, arbaclofen placarbil, BML-259, BRD-K72883421, and YC-1 had high affinity for GABBR2, and FABP3 bound with oleic, palmitic, and stearic acids. Arbaclofen and YC-1 activated GABAB receptor through PI3K/AKT and PKA/CREB pathways, respectively, thereby promoting neuronal anti-apoptotic effect and inhibiting p-tau and Aβ formation. Conclusions: This study provided a new strategy for the identification of targets and drugs for the treatment of AD using deep learning. Seven therapeutic targets and ten drugs were selected by using this method, providing new insight for AD treatment.

2024-06-03·Chemistry, an Asian journal

Synthesis of R–GABA Derivatives via Pd(II) Catalyzed Enantioselective C(sp³)−H Arylation and Virtual Validation with GABA_B1 Receptor for Potential leads

Article

作者: Saha, Diprupa ; Mohanlal, Smitha ; Sharma, Nagendra K. ; Pandey, Shubhant ; Acharya, Rudresh

Abstract:

GABA (γ–amino butyric acid) analogues like baclofen, tolibut, phenibut, etc., are well–known GABAB1 inhibitors and pharmaceutically important drugs. However, there is a huge demand for more chiral GABA aryl analogues with promising pharmacological actions. Here, we demonstrate the chiral ligand acetyl–protected amino quinoline (APAQ) mediated enantioselective synthesis of GABAB1 inhibitor drug scaffolds from easily accessible GABA via Pd–catalyzed C(sp3)−H activation. The synthetic methodology shows moderate to good yields, up to 74% of ee. We have successfully demonstrated the deprotection and removal of the directing group to synthesize R–tolibut in 86% yield. Further, we employed computation to probe the binding of R–GABA analogues to the extracellular domain of the human GABAB1 receptor. Our Rosetta–based molecular docking calculations show better binding for four R–enantiomers of GABA analogues than R–baclofen and R–phenibut. In addition, we employed GROMACS MD simulations and MMPB(GB)SA calculations to identify per–residue contribution to binding free energy. Our computational results suggest analogues (3R)‐4‐amino‐3‐(3,4‐dimethylphenyl) butanoic acid, (3R)‐4‐amino‐3‐(3‐fluorophenyl) butanoic acid, (3R)‐3‐(4‐acetylphenyl)‐4‐aminobutanoic acid, (3R)‐4‐amino‐3‐(4‐methoxyphenyl) butanoic acid, and (3R)‐4‐amino‐3‐phenylbutanoic acid are potential leads which could be synthesized from our methodology reported here.

2024-04-03·The Journal of neuroscience : the official journal of the Society for Neuroscience

Retinal GABAergic Alterations in Adults with Autism Spectrum Disorder

Article

作者: Ponteduro, Francesca M ; Mahroo, Omar A ; Daly, Eileen ; Dimitrov, Mihail ; Huang, Qiyun ; Velthuis, Hester ; Wong, Nichol M L ; McAlonan, Gráinne M ; Murphy, Declan G M ; Leo, Shaun M ; Ellis, Claire L ; Pereira, Andreia C

Alterations in γ-aminobutyric acid (GABA) have been implicated in sensory differences in individuals with autism spectrum disorder (ASD). Visual signals are initially processed in the retina, and in this study, we explored the hypotheses that the GABA-dependent retinal response to light is altered in individuals with ASD. Light-adapted electroretinograms were recorded from 61 adults (38 males and 23 females;n = 22 ASD) in response to three stimulus protocols: (1) the standard white flash, (2) the standard 30 Hz flickering protocol, and (3) the photopic negative response protocol. Participants were administered an oral dose of placebo, 15 or 30 mg of arbaclofen (STX209, GABABagonist) in a randomized, double-blind, crossover order before the test. At baseline (placebo), the a-wave amplitudes in response to single white flashes were more prominent in ASD, relative to typically developed (TD) participants. Arbaclofen was associated with a decrease in the a-wave amplitude in ASD, but an increase in TD, eliminating the group difference observed at baseline. The extent of this arbaclofen-elicited shift significantly correlated with the arbaclofen-elicited shift in cortical responses to auditory stimuli as measured by using an electroencephalogram in our prior study and with broader autistic traits measured with the autism quotient across the whole cohort. Hence, GABA-dependent differences in retinal light processing in ASD appear to be an accessible component of a wider autistic difference in the central processing of sensory information, which may be upstream of more complex autistic phenotypes.

项与 Baclofen Extended Release 相关的新闻（医药）

2023-12-11

·PRNewswire

Arbaclofen ER Emerging Drug Insight and Market Forecast to 2032

DUBLIN, Dec. 11, 2023 /PRNewswire/ -- The "Arbaclofen ER Emerging Drug Insight and Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about Arbaclofen ER for spasticity in the seven major markets. A detailed picture of the Arbaclofen ER for spasticity in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2019 -2032 is provided in this report along with a detailed description of the Arbaclofen ER for spasticity. The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the Arbaclofen ER market forecast analysis for spasticity in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in spasticity. Drug Summary Arbaclofen ER is an extended-release formulation of arbaclofen, the R isomer of baclofen that leverages the proprietary for osmodex drug delivery system and is being studied for the treatment of spasticity resulting from multiple sclerosis. It acts upstream of the mGluR5 receptor to increase inhibitory neurotransmission. It is the isomer of baclofen which harbors antispastic activity. The company is exploring opportunities to sell or out-license late-stage product candidate arbaclofen ER tablets designed to alleviate signs and symptoms of spasticity resulting from multiple sclerosis, for which they have completed Phase III clinical trials. The report provides insights into: A comprehensive product overview including the Arbaclofen ER description, mechanism of action, dosage and administration, research and development activities in spasticity. Elaborated details on Arbaclofen ER regulatory milestones and other development activities have been provided in this report. The report also highlights the Arbaclofen ER research and development activities in spasticity across the United States, Europe and Japan. The report also covers the patents information with expiry timeline around Arbaclofen ER. The report contains forecasted sales of Arbaclofen ER for spasticity till 2032. Comprehensive coverage of the late-stage emerging therapies for spasticity. The report also features the SWOT analysis with analyst views for Arbaclofen ER in spasticity. In-depth Arbaclofen ER Market Assessment This report provides a detailed market assessment of Arbaclofen ER for spasticity in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2026 to 2032. Arbaclofen ER Clinical Assessment The report provides the clinical trials information of Arbaclofen ER for spasticity covering trial interventions, trial conditions, trial status, start and completion dates. Report Highlights In the coming years, the market scenario for spasticity is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market. The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Arbaclofen ER dominance. Other emerging products for spasticity are expected to give tough market competition to Arbaclofen ER and launch of late-stage emerging therapies in the near future will significantly impact the market. A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of Arbaclofen ER in spasticity. This in-depth analysis of the forecasted sales data of Arbaclofen ER from 2026 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Arbaclofen ER in spasticity. Key Questions What is the product type, route of administration and mechanism of action of Arbaclofen ER? What is the clinical trial status of the study related to Arbaclofen ER in spasticity and study completion date? What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Arbaclofen ER development? What are the key designations that have been granted to Arbaclofen ER for spasticity? What is the forecasted market scenario of Arbaclofen ER for spasticity? What are the forecasted sales of Arbaclofen ER in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan? What are the other emerging products available and how are these giving competition to Arbaclofen ER for spasticity? Which are the late-stage emerging therapies under development for the treatment of spasticity? Key Topics Covered: 1. Report Introduction 2. Arbaclofen ER Overview in Spasticity 2.1. Product Detail 2.2. Clinical Development 2.2.1. Clinical studies 2.2.2. Clinical trials information 2.2.3. Safety and efficacy 2.3. Regulatory Milestone 2.4. Other Developmental Activities 2.5. Product Profile 3. Competitive Landscape (Marketed Therapies) 4. Competitive Landscape (Late-stage Emerging Therapies) 5. Arbaclofen ER Market Assessment 5.1. Market Outlook of Arbaclofen ER in Spasticity 5.2. 7MM Analysis 5.2.1. Market Size of Arbaclofen ER in the 7MM for Spasticity 5.3. Country-wise Market Analysis 6. SWOT Analysis 7. Analysts' Views For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo - SOURCE Research and Markets

临床3期

2023-09-18

·PRNewswire

Allos Pharma Inc. Expands Intellectual Property Rights for Arbaclofen

CAMBRIDGE, Mass., Sept. 18, 2023 /PRNewswire/ -- Allos Pharma Inc. ("Allos"), a biopharmaceutical company specializing in the development of treatments for rare neurological disorders, announced today that it has expanded its intellectual property rights with a new patent family. A new patent family was filed to the United States Patent Trademark & Office earlier in 2023. This new patent family comes in addition to an existing granted patent family. Continue Reading Allos also announces today the worldwide exclusive rights to granted patents and clinical programs for arbaclofen in further indications, including Autism Spectrum Disorder. This is in addition to the current Fragile X Syndrome development program, for which there are no approved medications, and where arbaclofen has Orphan Drug Designation. Expanded arbaclofen rights with a newly filed patent family and with exclusive rights in all indications, incl. Autism. Tweet this "This license builds upon the progress in our Fragile X Syndrome program, where we have achieved alignment with the fragile X community and the FDA on the design of the confirmatory Phase 3 clinical trial. We are excited to have the rights to develop arbaclofen in additional indications as clear efficacy signals were observed in recent trials in individuals with idiopathic Autism Spectrum Disorder." said Dr. Randall Carpenter, MD, co-founder of Allos Pharma Inc. In May 2023, the results of two autism studies, in Canada (n=90) and EU (n=122), were presented at the annual meeting of the International Society for Autism Research. The two studies had nearly identical protocols and endpoints. Improvement was seen in both studies on the primary endpoint (Socialization Domain, Vineland-3) but did not reach statistical significance. Nominally significant improvements were seen in one or both studies on other measures of social skill (Social Responsiveness Scale, Aberrant Behavior Checklist-Social Withdrawal, Autism Impact Measure). A subject-level meta-analysis is planned. "We remain committed to providing new treatment options for patients and families affected by Fragile X Syndrome and Autism Spectrum Disorder, and we believe that arbaclofen has the potential to make a significant, positive impact on their lives." Dr. Randall Carpenter, MD, co-founder of Allos Pharma Inc About Allos Pharma Inc. Allos Pharma Inc. is a biopharmaceutical company dedicated to the development of treatments for rare neurological disorders. Allos' investigational drug, arbaclofen, is currently in development for the treatment of Fragile X Syndrome and Autism Spectrum Disorder. For more information, please visit Allos Pharma Inc.'s website at SOURCE Allos Pharma Inc.

临床3期孤儿药

2023-08-18

·Pharmaceutical Technology

AbbVie achieves win for migraine prevention drug Aquipta in Europe

Adam Zamecnik @a_zamecnik The approval of Aquipta is based on the results of the two Phase III studies. Credit: Shutterstock / Prostock-studio. The European Commission has approved AbbVie’s Aquipta as migraine prophylaxis for adult patients, making it the first daily oral treatment of its class to be approved in the EU for the prevention of both chronic and episodic migraines. Several calcitonin gene-related peptide (CGRP) antibodies are administered subcutaneously or via intravenous infusions. But there is a preference among patients for oral therapies, says Dawn Carlson, vice president, Neuroscience Development at AbbVie , in an interview with Pharmaceutical Technology. Lundbeck’s CGRP antibody Vyepti (eptinezumab), is administered through intravenous infusions, while Amgen’s Aimovig (erenumab) is injected subcutaneously. Recommended Reports Reports LOA and PTSR Model - Dexmedetomidine in Opium (Opioid) Addiction GlobalData Reports LOA and PTSR Model - Arbaclofen Er in Opium (Opioid) Addiction GlobalData View all Companies Intelligence AbbVie Inc Amgen Inc Lundbeck LLC Progress Kft View all The approval of Aquipta is based on the results of the two Phase III studies—ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which both met their primary endpoint of a statistically significant reduction in mean monthly migraine days versus placebo, per the 17 August announcement . In the PROGRESS trial, patients in the 60mg Aquipta cohort reported a 6.8-day reduction in mean monthly migraine days, while those on placebo experienced a 5.1-day reduction. Such a reduction represents a clinically meaningful change in the experience of patients who feel pain not just during the actual migraine attack, but also in the symptoms prior to the attack, explains Carlson. The studies’ secondary endpoints were equally meaningful, with decreases in headache days and medication use, she adds. Also known as atogepant, Aquipta is a CGRP receptor antagonist (gepant). The US Food and Drug Administration (FDA) first approved the treatment for prophylactic use as an episodic migraine treatment in September 2021. In April 2023, AbbVie managed to expand the drug’s label to chronic migraines. While the drug’s European brand name is Aquipta, it is sold under the name Qulipta in Canada and the US. Carlson says: “Now that we’ve received approval, AbbVie is committed to bringing these expeditiously to patients and we’re working with the appropriate country authorities and reimbursement agencies to bring these solutions as quickly as we can…But that will take some time.” According to a GlobalData consensus sales forecast, Aquipta/Qulipta is projected to have global sales of $1.37bn in 2029. GlobalData is the parent company of Pharmaceutical Technology . Beyond the EU and countries where the drug was already approved, AbbVie is on the lookout for further expansion. “We know that migraine is a global disease with over a billion patients suffering, and we are committed to exploring options in other countries. And that’s on a case-by-case basis, but we are looking at other areas to bring this forward because AbbVie is committed to finding solutions for patients suffering from migraine.”

临床3期临床结果上市批准

100 项与 Baclofen Extended Release 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Baclofen Extended Release	-	DB08891

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
多发性硬化症	临床3期	美国	Osmotica Pharmaceutical US LLC	2012-11-01
多发性硬化症	临床3期	俄罗斯	Osmotica Pharmaceutical US LLC	2012-11-01
多发性硬化症	临床3期	乌克兰	Osmotica Pharmaceutical US LLC	2012-11-01
肌肉痉挛	临床3期	美国	Osmotica Pharmaceutical US LLC	2012-11-01
肌肉痉挛	临床3期	俄罗斯	Osmotica Pharmaceutical US LLC	2012-11-01
肌肉痉挛	临床3期	乌克兰	Osmotica Pharmaceutical US LLC	2012-11-01
自闭症谱系障碍	临床3期	美国	Seaside Therapeutics LLC	2011-11-01
脆性X综合征	临床3期	美国	Seaside Therapeutics LLC	2011-05-01
情绪易怒	临床2期	美国	Seaside Therapeutics LLC	2008-11-01
自闭症	临床1期	美国	The Children's Hospital of Philadelphia	2016-02-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03290131 (OS440-3004, CTgov)	临床3期	肌肉痉挛 \| 多发性硬化症	536	Arbaclofen (AERT 40 mg)	夢夢齋窪窪齋窪衊糧網(蓋鏇鬱醖築壓醖淵壓遞) = 築觸齋壓膚遞鹽衊獵膚憲鑰鹹鑰糧衊鹹積選願 (夢憲鬱壓構顧膚糧膚築, 簾範夢獵襯壓鹽襯憲積 ~ 鬱鹹膚壓繭糧獵簾顧選) 更多	-	2022-07-15
				Arbaclofen (AERT 80 mg)	夢夢齋窪窪齋窪衊糧網(蓋鏇鬱醖築壓醖淵壓遞) = 蓋齋簾觸遞顧範範觸窪憲鑰鹹鑰糧衊鹹積選願 (夢憲鬱壓構顧膚糧膚築, 艱鏇糧遞夢積膚簾鏇顧 ~ 衊顧獵遞窪顧簾選繭鏇) 更多
NCT03319732 (OS440-3005, CTgov)	临床3期	肌肉痉挛 \| 多发性硬化症	323	Arbaclofen	襯齋壓選淵憲鏇淵範遞(艱夢糧廠窪壓繭廠餘鑰) = 鹽淵簾醖壓鏇餘壓壓艱窪壓齋夢鑰鏇壓憲廠齋 (觸積繭製鬱憲範構夢鑰, 鹹鹹簾願憲範鑰醖鏇衊 ~ 廠憲襯齋構範窪獵範壓) 更多	-	2022-07-15
NCT01325220 (Biospace) 人工标引	临床3期	脆性X综合征	-	Arbaclofen	淵繭鑰顧獵糧範醖醖顧(選範範淵壓製願淵餘齋) = 顧築餘網醖艱憲觸淵鹹鏇鬱築遞鏇鏇觸選鬱蓋 (鹽襯糧鬱獵構鑰網淵鑰 )	积极	2022-07-14
				Placebo	淵繭鑰顧獵糧範醖醖顧(選範範淵壓製願淵餘齋) = 製餘製膚獵壓簾鑰製餘鏇鬱築遞鏇鏇觸選鬱蓋 (鹽襯糧鬱獵構鑰網淵鑰 )
NCT01282268 (Pubmed \| J Neurodev Disord) 人工标引	临床3期	脆性X综合征	119	Arbaclofen	鹽廠觸憲選鏇鏇夢築構(襯蓋鑰襯觸夢醖艱繭衊) = 範製廠範鬱壓遞廠鏇蓋簾網壓網壓壓襯鹹衊襯 (遞範衊窪齋鑰鹹鬱鹹廠 )	不佳	2017-06-12
				Placebo	鹽廠觸憲選鏇鏇夢築構(襯蓋鑰襯觸夢醖艱繭衊) = 範夢壓壓齋積觸築醖構簾網壓網壓壓襯鹹衊襯 (遞範衊窪齋鑰鹹鬱鹹廠 )
NCT00846547 (CTgov)	临床2期	自闭症谱系障碍 \| 情绪易怒	32	Arbaclofen	壓膚築淵廠糧築鏇壓夢(製願醖構餘淵遞糧鹽鹹) = 鏇餘鹽鬱繭餘齋遞鏇壓襯鬱鑰網製蓋鹹蓋積壓 (鹽積壓製憲糧窪選膚網, 遞製顧壓鹹鑰鹹顧選遞 ~ 鏇鏇願網簾廠醖憲淵夢) 更多	-	2013-06-14
NCT00788073 (CTgov)	临床2期	情绪易怒 \| 脆性X综合征	63	STX209 (STX209)	膚構淵壓壓鏇網遞糧糧(觸繭窪簾獵醖鬱淵獵網) = 積鏇壓齋鹹鹹選壓齋壓壓襯夢廠齋窪夢艱膚遞 (壓壓淵齋鏇衊夢繭遞簾, 憲顧鹹膚遞製製願淵膚 ~ 獵築鹽淵選夢膚壓壓網) 更多	-	2013-05-06
				Placebo (Placebo)	膚構淵壓壓鏇網遞糧糧(觸繭窪簾獵醖鬱淵獵網) = 遞遞糧醖憲衊鑰觸蓋壓壓襯夢廠齋窪夢艱膚遞 (壓壓淵齋鏇衊夢繭遞簾, 簾廠糧衊窪窪鏇鹽築壓 ~ 廠網襯築製衊窪遞膚遞) 更多