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Eluxadoline

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https://www.readbyqxmd.com/read/29659201/evaluation-of-eluxadoline-effect-on-cardiac-repolarization
#1
Laura Bonifacio, Thomas L Hunt, Gail McIntyre, Leonard S Dove, Paul S Covington
This study evaluated the effects of eluxadoline, a mixed μ-opioid receptor (OR) and κ-OR agonist and δ-OR antagonist, on cardiac repolarization. This evaluator-blinded, placebo- and positive-controlled, 4-period crossover study randomized healthy men and women to single oral doses of eluxadoline (therapeutic dose 100 mg or supratherapeutic dose 1000 mg), moxifloxacin 400 mg, or placebo. QT data were corrected using individual custom correction (QTcI). The primary endpoint was the change from baseline in QTcI intervals (ΔQTcI) between eluxadoline and placebo (ΔΔQTcI)...
April 16, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29644734/editorial-the-sphincter-of-oddi-strikes-again-eluxadoline-illuminates-a-controversial-mechanism-for-the-pathogenesis-of-acute-pancreatitis
#2
EDITORIAL
G A Coté
No abstract text is available yet for this article.
May 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29575372/radar-plots-a-novel-modality-for-displaying-disparate-data-on-the-efficacy-of-eluxadoline-for-the-treatment-of-irritable-bowel-syndrome-with-diarrhea
#3
D M Brenner, L S Dove, D A Andrae, P S Covington, C Gutman, W D Chey
BACKGROUND: Patients with irritable bowel syndrome with diarrhea (IBS-D) experience a range of abdominal and bowel symptoms; successful management requires alleviation of this constellation of symptoms. Eluxadoline, a locally active mixed μ- and κ-opioid receptor agonist and δ-opioid receptor antagonist, is approved for the treatment of IBS-D in adults based on the results of 2 Phase 3 studies. Radar plots can facilitate comprehensive, visual evaluation of diverse but interrelated efficacy endpoints...
March 25, 2018: Neurogastroenterology and Motility: the Official Journal of the European Gastrointestinal Motility Society
https://www.readbyqxmd.com/read/29451407/advancements-in-drug-development-for-diarrhea-predominant-irritable-bowel-syndrome
#4
REVIEW
Giovanni Dothel, Maria Raffaella Barbaro, Emanuel Raschi, Giovanni Barbara, Fabrizio De Ponti
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common disorder characterized by a complex pathophysiology hampering optimal targeted drug development. Recent advances in our understanding of key underlying mechanisms prompted novel therapeutics including novel pharmacological approaches. Areas covered: This review summarizes the latest advancements in the pipeline of IBS-D drugs focusing on new pharmacological targets, efficacy and safety of medicinal products considering the recent harmonization of regulatory requirements by the FDA and the EMA...
March 2018: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/29372994/evidence-based-management-of-irritable-bowel-syndrome-with-diarrhea
#5
Mark Pimentel
Irritable bowel syndrome (IBS), a complex disorder of the gastrointestinal tract, is characterized by abdominal pain associated with defecation or changes in stool form or frequency. IBS is associated with substantial burden, including direct medical costs and indirect costs. Direct costs associated with IBS in the United States have been estimated to exceed $1 billion. However, indirect costs, such as negative effect on quality of life (QOL) and work productivity, are difficult to quantify. There are 3 main subtypes: IBS with prominent diarrhea (IBS-D), IBS with constipation, and IBS with mixed symptoms of both constipation and diarrhea...
January 2018: American Journal of Managed Care
https://www.readbyqxmd.com/read/29372991/evidence-based-management-of-irritable-bowel-syndrome-with-diarrhea
#6
Mark Pimentel
Irritable bowel syndrome (IBS), a complex disorder of the gastrointestinal tract, is characterized by abdominal pain associated with defecation or changes in stool form or frequency. IBS is associated with substantial burden, including direct medical costs and indirect costs. Direct costs associated with IBS in the United States have been estimated to exceed $1 billion. However, indirect costs, such as negative effect on quality of life (QOL) and work productivity, are difficult to quantify. There are 3 main subtypes: IBS with prominent diarrhea (IBS-D), IBS with constipation, and IBS with mixed symptoms of both constipation and diarrhea...
January 2018: American Journal of Managed Care
https://www.readbyqxmd.com/read/29349789/postmarketing-cases-of-eluxadoline-associated-pancreatitis-in-patients-with-or-without-a-gallbladder
#7
L Harinstein, E Wu, A Brinker
BACKGROUND: Cases of pancreatitis were identified in the eluxadoline clinical development program, reflected in initial product labelling, and the subject of postmarketing reports. AIM: To analyse postmarketing cases of eluxadoline-associated pancreatitis. METHODS: We retrospectively analysed all US adverse event reports of pancreatitis associated with eluxadoline reported to the FDA Adverse Event Reporting System (FAERS) database from May 27, 2015 through February 15, 2017...
March 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29209215/preparation-evaluation-and-bioavailability-studies-of-eudragit-coated-plga-nanoparticles-for-sustained-release-of-eluxadoline-for-the-treatment-of-irritable-bowel-syndrome
#8
Md K Anwer, Ramadan Al-Shdefat, Essam Ezzeldin, Saad M Alshahrani, Abdullah S Alshetaili, Muzaffar Iqbal
Eluxadoline is a newly approved orally administered drug used for the treatment of Irritable Bowel Syndrome with Diarrhea. It is reported as a poorly water-soluble drug due to which its dissolution rate and oral bioavailability are very poor. In this work, various plain PLGA nanoparticles (NPs) (F1-F4) were prepared and optimized based on particle size, PDI, zeta potential and percent drug entrapment efficiency (EE). The developed plain NPs (F1-F4) showed average particle size ranging from 260.19 to 279.76 nm with smooth surface and EE of 17...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/29172123/existing-and-emerging-therapies-for-managing-constipation-and-diarrhea
#9
REVIEW
Adil E Bharucha, Mira M Wouters, Jan Tack
Functional bowel disorders (i.e., constipation and diarrhea) are characterized by abdominal pain, bloating, distention, and/or bowel habit abnormalities in the absence of obvious anatomic or physiologic abnormalities on routine diagnostic tests. These symptoms are attributable to gastrointestinal sensorimotor dysfunctions resulting from peripheral and/or central mechanisms. Available drugs target the underlying bowel disturbance (i.e., constipation, diarrhea, or both), supplemented when necessary by management of pain...
December 2017: Current Opinion in Pharmacology
https://www.readbyqxmd.com/read/29155353/advantages-and-limitations-of-the-federal-adverse-events-reporting-system-in-assessing-adverse-event-reporting-for-eluxadoline
#10
EDITORIAL
Victor Chedid, Priya Vijayvargiya, Michael Camilleri
No abstract text is available yet for this article.
March 2018: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/29121571/high-throughput-%C3%AE-spe-based-elution-coupled-with-uplc-ms-ms-for-determination-of-eluxadoline-in-plasma-sample-application-in-pharmacokinetic-characterization-of-plga-nanoparticle-formulations-in-rats
#11
Muzaffar Iqbal, Essam Ezzeldin, Khalid A Al-Rashood, Ramadan Al-Shdefat, Md Khalid Anwer
Eluxadoline is a novel μ- and κ-opioid receptor (OR) agonist and δ-OR antagonist, recently approved as a first line therapy for the treatment of irritable bowel syndrome. Due to abuse potential, poor bioavailability and high intersubject variability, a sensitive and reliable assay is prerequisite for its determination in biological samples. This work first time report the development and validation of UPLC-MS/MS assay for determination of eluxadoline in rat plasma sample using risperidone as an internal standard (IS)...
February 5, 2018: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29095765/new-therapies-in-irritable-bowel-syndrome-what-works-and-when
#12
Orla Craig
PURPOSE OF REVIEW: The purpose of this review is to examine the evidence supporting the use of recently developed pharmacological treatments for IBS together with new evidence supporting more traditional therapies in order to understand where the new agents are best used in the treatment pathway. RECENT FINDINGS: There is evidence to support the use of traditional treatments such as antispasmodics, antidepressants and dietary alteration in IBS. New therapeutic agents such as Linaclotide, Lubiprostone, Plecanatide, Rifaxamin and Eluxadoline are all more effective than placebo in treating symptoms of IBS with Tenapanor being a promising new agent...
January 2018: Current Opinion in Gastroenterology
https://www.readbyqxmd.com/read/29090081/eluxadoline-in-irritable-bowel-syndrome-with-diarrhea-rationale-evidence-and-place-in-therapy
#13
REVIEW
Kenneth Barshop, Kyle Staller
Irritable bowel syndrome (IBS) is the most common gastrointestinal (GI) disorder worldwide, however treatment options for diarrhea-predominant IBS (IBS-D) remain limited. Eluxadoline, a µ- and κ-opioid receptor agonist and δ-opioid receptor antagonist, was recently approved for the treatment of IBS-D. A novel compound first described in 2008, eluxadoline was shown to normalize GI transit, with a subsequent phase I demonstrating its safety and tolerability in healthy adults. In 2016, two randomized, double-blind, placebo-controlled phase III trials studying eluxadoline use at 75 mg and 100 mg twice daily over 26 weeks demonstrated a significant improvement in stool consistency and many global symptoms of IBS...
November 2017: Therapeutic Advances in Chronic Disease
https://www.readbyqxmd.com/read/29033544/eluxadoline-in-the-treatment-of-diarrhea-predominant-irritable-bowel-syndrome
#14
REVIEW
Ayşe Elif Özdener, Anastasia Rivkin
Eluxadoline is a novel drug approved for the management of diarrhea predominant irritable bowel syndrome (IBS-D). It has unique pharmacology and works on three different opioid receptors. Several Phase II and III clinical trials have demonstrated eluxadoline's efficacy in reducing symptoms related to IBS-D. Clinical trial results and postmarketing reports show a risk of pancreatitis in patients without a gallbladder or those abusing alcohol. This review article will include information on clinical trial results related to IBS-D management as well as eluxadoline's limitations...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28989282/spotlight-on-eluxadoline-for-the-treatment-of-patients-with-irritable-bowel-syndrome-with-diarrhea
#15
REVIEW
Konstantinos C Fragkos
BACKGROUND: Irritable bowel syndrome with diarrhea (IBS-D) has limited options for treatment currently, including mainly anti-motility medications, antispasmodics, and antidepressants. This review discusses the properties of a new drug, eluxadoline, a gut-targeting mu- and kappa-opioid receptor agonist and a delta-opioid receptor antagonist, and its efficacy and safety in patients with IBS-D. MATERIALS AND METHODS: A systematic review of the literature was undertaken to identify studies that had investigated eluxadoline as a treatment in IBS-D...
2017: Clinical and Experimental Gastroenterology
https://www.readbyqxmd.com/read/28978966/safety-of-eluxadoline-in-patients-with-irritable-bowel-syndrome
#16
Ryan Croteau, Jamie S Barkin
No abstract text is available yet for this article.
October 2017: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/28978951/safety-of-eluxadoline-in-patients-with-ibs-d-without-a-gallbladder
#17
Brooks D Cash, Brian E Lacy, Philip S Schoenfeld, Leonard S Dove, Paul S Covington
No abstract text is available yet for this article.
October 2017: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/28932272/the-place-of-eluxadoline-in-the-management-of-irritable-bowel-syndrome-with-diarrhea
#18
REVIEW
Sherry Levio, Brooks D Cash
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized by abdominal pain associated with defecation with altered stool frequency or stool form. The global prevalence of IBS ranges from 10% to 15% and total healthcare cost attributable to IBS is significant. Among individuals with IBS, the condition has dramatic effects on health-related quality of life, work and school productivity, and activities of daily living. It may be diagnosed with confidence, based on symptom-based diagnostic criteria, exclusion of alarm features and directed diagnostic testing...
September 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28863986/nice-guidance-on-eluxadoline-for-treating-irritable-bowel-syndrome-with-diarrhoea
#19
Amanda I Adler
No abstract text is available yet for this article.
November 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28808082/%C3%AE-eluxadoline-for-ibs-d
#20
(no author information available yet)
No abstract text is available yet for this article.
August 2017: Drug and Therapeutics Bulletin
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