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.

Start Date01 Jan 2026

Sponsor / Collaborator

RVL Pharmaceuticals, Inc.

NCT05617118 / RecruitingNot ApplicableIIT

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.

Start Date01 Dec 2022

Sponsor / Collaborator

St. Petersburg State University

[+1]

NCT04271332 / Active, not recruitingPhase 2

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.

Start Date01 Sep 2022

Sponsor / Collaborator

Clinical Research Associates, LLC

100 Clinical Results associated with Baclofen Extended Release

100 Translational Medicine associated with Baclofen Extended Release

100 Patents (Medical) associated with Baclofen Extended Release

116

Literatures (Medical) associated with Baclofen Extended Release

14 Sep 2023·bioRxiv : the preprint server for biology

Towards Preclinical Validation of Arbaclofen (R-baclofen) Treatment for 16p11.2 Deletion Syndrome.

Author: Schultz, Maria N ; Tsukahara, Tatsuya ; Gundersen, Brigitta B ; Datta, Sandeep Robert ; Herault, Yann ; Schaffler, Melanie D ; Luo Clayton, Alice H ; O'Brien, William T ; Abel, Ted ; Nalesso, Valerie ; Lorenzo, Sandra Martin ; Crawley, Jacqueline N

A microdeletion on human chromosome 16p11.2 is one of the most common copy number variants associated with autism spectrum disorder and other neurodevelopmental disabilities. Arbaclofen, a GABA(B) receptor agonist, is a component of racemic baclofen, which is FDA-approved for treating spasticity, and has been shown to alleviate behavioral phenotypes, including recognition memory deficits, in animal models of 16p11.2 deletion. Given the lack of reproducibility sometimes observed in mouse behavioral studies, we brought together a consortium of four laboratories to study the effects of arbaclofen on behavior in three different mouse lines with deletions in the mouse region syntenic to human 16p11.2 to test the robustness of these findings. Arbaclofen rescued cognitive deficits seen in two 16p11.2 deletion mouse lines in traditional recognition memory paradigms. Using an unsupervised machine-learning approach to analyze behavior, one lab found that arbaclofen also rescued differences in exploratory behavior in the open field in 16p11.2 deletion mice. Arbaclofen was not sedating and had modest off-target behavioral effects at the doses tested. Our studies show that arbaclofen consistently rescues behavioral phenotypes in 16p11.2 deletion mice, providing support for clinical trials of arbaclofen in humans with this deletion.

01 Sep 2023·Medicina

[Autism. Pharmacological treatment].

Review

Author: Ruggieri, Víctor

Autism is a neurodevelopmental disorder characterized by deficits in social cognition and communication, restricted interests, and stereotyped behaviors. Frequently associated with sensory dysfunction, other neurodevelopmental disorders, neuropsychiatric disorders, epilepsy and/or sleep disorders. This condition will accompany people throughout their lives, which will generate various support and treatment needs. Although there are no drugs that modify the core symptoms of autism, various drugs have shown their usefulness in associated conditions. Atypical antipsychotics for hyperactivity, impulsivity, agitation, auto or heteroaggression crises. Serotonin reuptake inhibitors, to decrease anxiety, obsessive-compulsive symptoms, and irritability/agitation. Stimulants and atomoxetine used for hyperactivity, inattention, and impulsivity. Clonidine and guanfacine show some efficacy on hyperactivity and stereotyped behaviors. Buspirone has been used for restrictive behaviors and anxiety. There are drugs in the research phase such as oxytocin, vasopressin and even some developed for specific entities related to autism such as arbaclofen in Fragile X and Trofinetide that has just been approved for use in Rett syndrome. As specific entities and their pathophysiology are identified, it is likely that tailored treatments will be developed for each entity associated with autism..

01 Jan 2023·Frontiers in pharmacology

Sex-related differences in the efficacy of Baclofen enantiomers on self-administered alcohol in a binge drinking pattern and dopamine release in the core of the nucleus accumbens.

Article

Author: Bodeau, Sandra ; Vorspan, Florence ; Naassila, Mickael ; de Sousa, Sofia Vilelas ; Labat, Laurence ; Soichot, Marion ; Fernandez Rodriguez, Sandra ; Houdant, Charles ; Jeanblanc, Virginie ; Jeanblanc, Jérôme ; Sauton, Pierre

Introduction: Clinical studies on the effectiveness of Baclofen in alcohol use disorder (AUD) yielded mixed results possibly because of differential effects of the enantiomers and sex-related differences. Here we examined the effect of the different Baclofen enantiomers on alcohol intake and on evoked dopamine release in the core of the nucleus accumbens (NAcc) in male and female Long Evans rats. Methods: Rats were trained to chronically self-administer 20% alcohol solution in daily binge drinking sessions and were treated with the different forms of Baclofen [RS(±), R(+) and S(-)]. The effects on the evoked dopamine release within the core of the nucleus accumbens were measured in brain slices from the same animals and the alcohol naïve animals using the fast scan cyclic voltammetry technique. Results: RS(±)-Baclofen reduced alcohol intake regardless of sex but more females were non-responders to the treatment. R(+)-Baclofen also reduced alcohol intake regardless of sex but females were less sensitive than males. S(-)-Baclofen did not have any effect on average but in some individuals, especially in the females, it did increase alcohol intake by at least 100%. There were no sex differences in Baclofen pharmacokinetic but a strong negative correlation was found in females with a paradoxical effect of increased alcohol intake with higher blood Baclofen concentration. Chronic alcohol intake reduced the sensitivity to the effect of Baclofen on evoked dopamine release and S(-)-Baclofen increased dopamine release specifically in females. Discussion: Our results demonstrate a sex-dependent effect of the different forms of Baclofen with no or negative effects (meaning an increase in alcohol self-administration) in subgroup of females that could be linked to a differential effect on dopamine release and should warrant future clinical studies on alcohol use disorder pharmacotherapy that will deeply analyze sex difference.

News (Medical) associated with Baclofen Extended Release

11 Dec 2023

·www.prnewswire.com

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

Phase 3

18 Sep 2023

·www.prnewswire.com

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.

Phase 3Orphan Drug

18 Aug 2023

·www.pharmaceutical-technology.com

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.”

Phase 3Clinical ResultDrug Approval

100 Deals associated with Baclofen Extended Release

External Link

KEGG	Wiki	ATC	Drug Bank
-	Baclofen Extended Release	-	DB08891

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Sclerosis	Phase 3	US	Osmotica Pharmaceutical US LLC	01 Nov 2012
Multiple Sclerosis	Phase 3	RU	Osmotica Pharmaceutical US LLC	01 Nov 2012
Multiple Sclerosis	Phase 3	UA	Osmotica Pharmaceutical US LLC	01 Nov 2012
Muscle Spasticity	Phase 3	US	Osmotica Pharmaceutical US LLC	01 Nov 2012
Muscle Spasticity	Phase 3	RU	Osmotica Pharmaceutical US LLC	01 Nov 2012
Muscle Spasticity	Phase 3	UA	Osmotica Pharmaceutical US LLC	01 Nov 2012
Autism Spectrum Disorder	Phase 3	US	Seaside Therapeutics LLC	01 Nov 2011
Fragile X Syndrome	Phase 3	US	Seaside Therapeutics LLC	01 May 2011
Irritable Mood	Phase 2	US	Seaside Therapeutics LLC	01 Nov 2008
Autistic Disorder	Phase 1	US	The Children's Hospital of Philadelphia	01 Feb 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03319732 (OS440-3005, CTgov)	Phase 3	Muscle Spasticity \| Multiple Sclerosis	323	Arbaclofen	evpauctsdf(hxgzyqovrf) = ppqlqqhdka bmachvjwoi (ywcbwpebge, dgauoytsgi - blulnqrmec) View more	-	15 Jul 2022
NCT03290131 (OS440-3004, CTgov)	Phase 3	Muscle Spasticity \| Multiple Sclerosis	536	Arbaclofen (AERT 40 mg)	crtqzwfgum(pnssecyxxb) = yyoxphbqll zukejobiph (wajizmkvcu, bdazrswoqg - xsqwjlfebc) View more	-	15 Jul 2022
				Arbaclofen (AERT 80 mg)	crtqzwfgum(pnssecyxxb) = rhadeifwhu zukejobiph (wajizmkvcu, syvyoqjzup - cccqgkociz) View more
NCT01325220 (Biospace) Manual	Phase 3	Fragile X Syndrome	-	Arbaclofen	dttxvkcshs(tuqwgltvnx) = xzdlbrdtsc niuvshozjp (yqnaxqteba )	Positive	14 Jul 2022
				Placebo	dttxvkcshs(tuqwgltvnx) = ewtbmtneui niuvshozjp (yqnaxqteba )
NCT01282268 (Pubmed \| J Neurodev Disord) Manual	Phase 3	Fragile X Syndrome	119	Arbaclofen	ogvoboazqr(zwsmxjoyop) = oxceuhbcfy jkmnhehhva (mowdfraodw )	Negative	12 Jun 2017
				Placebo	ogvoboazqr(zwsmxjoyop) = xkvuadfyxw jkmnhehhva (mowdfraodw )
NCT00846547 (CTgov)	Phase 2	Autism Spectrum Disorder \| Irritable Mood	32	Arbaclofen	qxpdfhrzmj(avpfgqfswm) = lwsbufvvsj iaceewjjbz (ccnhsojefp, ucktomcekq - hkenspbseg) View more	-	14 Jun 2013
NCT00788073 (CTgov)	Phase 2	Irritable Mood \| Fragile X Syndrome	63	STX209 (STX209)	fyihlczzdb(zclqaifnyt) = fbpaxyhhkc wlptmppdxl (quhzsaursb, obnxeonsbc - rxnjrfembo) View more	-	06 May 2013
				Placebo (Placebo)	fyihlczzdb(zclqaifnyt) = snhywxwshe wlptmppdxl (quhzsaursb, tkfhwnvjra - rlpezzqqaj) View more

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