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Eluxadoline for Irritable Bowel Syndrome with Diarrhea

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https://www.readbyqxmd.com/read/28747053/eluxadoline-in-the-treatment-of-diarrhea-predominant-irritable-bowel-syndrome-the-sepd-perspective
#1
Isabel Vera, F Javier Júdez
Functional gut disorders, including diarrhea-predominant irritable bowel syndrome, are highly prevalent conditions worldwide that significantly impact health economy and patient quality of life, yet lacking fully satisfactory therapeutic options. These circumstances fostered research on various molecules with more specific therapeutic targets, including opioid receptors. Eluxadoline (Allergan's Vibercy® in the USA, Truberzi® in Europe) is a locally-acting mixed - and -opioid receptor agonist, and -opioid receptor antagonist, that was licensed in 2015 by the Food and Drug Administration (FDA) and in 2016 by the European Medicines Agency (EMA) for use in diarrhea-predominant irritable bowel syndrome...
July 27, 2017: Revista Española de Enfermedades Digestivas
https://www.readbyqxmd.com/read/28729815/symposium-report-an-evidence-based-approach-to-ibs-and-cic-applying-new-advances-to-daily-practice-a-review-of-an-adjunct-clinical-symposium-of-the-american-college-of-gastroenterology-meeting-october-16-2016-%C3%A2-las-vegas-nevada
#2
William D Chey
Many nonpharmacologic and pharmacologic therapies are available to manage irritable bowel syndrome (IBS) and chronic idiopathic constipation (CIC). The American College of Gastroenterology (ACG) regularly publishes reviews on IBS and CIC therapies. The most recent of these reviews was published by the ACG Task Force on the Management of Functional Bowel Disorders in 2014. The key objective of this review was to evaluate the efficacy of therapies for IBS or CIC compared with placebo or no treatment in randomized controlled trials...
February 2017: Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28674470/eluxadoline-viberzi-a-mu-opioid-receptor-agonist-for-the-treatment-of-irritable-bowel-syndrome-with-diarrhea
#3
Fraidy Maltz, Brooke Fidler
Eluxadoline (Viberzi) for the treatment of irritable bowel syndrome with diarrhea.
July 2017: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/28417992/eluxadoline-efficacy-in-ibs-d-patients-who-report-prior-loperamide-use
#4
Brian E Lacy, William D Chey, Brooks D Cash, Anthony J Lembo, Leonard S Dove, Paul S Covington
OBJECTIVES: Irritable bowel syndrome with diarrhea (IBS-D) is often managed with over-the-counter therapies such as loperamide, though with limited success. This analysis evaluated the efficacy of eluxadoline in patients previously treated with loperamide in two phase 3 studies. METHODS: Adults with IBS-D (Rome III criteria) were enrolled and randomized to placebo or eluxadoline (75 or 100 mg) twice daily for 26 (IBS-3002) or 52 (IBS-3001) weeks. Patients reported loperamide use over the previous year and recorded their rescue loperamide use during the studies...
June 2017: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/28203283/current-and-emergent-pharmacologic-treatments-for-irritable-bowel-syndrome-with-diarrhea-evidence-based-treatment-in-practice
#5
REVIEW
Susan Lucak, Lin Chang, Albena Halpert, Lucinda A Harris
Irritable bowel syndrome with diarrhea (IBS-D) is a common, chronic functional gastrointestinal disorder with symptoms that can be distressing for patients and often result in substantially impaired quality of life. This review focuses on providing clinicians with information on practical, evidence-based treatment for IBS-D. Current therapies commonly used for the treatment of IBS-D, including pharmacologic and nonpharmacologic interventions, are briefly reviewed, followed by discussion of the emergent pharmacologic treatments (rifaximin and eluxadoline) and medical foods (IBgard(®) and EnteraGam(®))...
February 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28167156/eluxadoline-demonstrates-a-lack-of-abuse-potential-in-phase-2%C3%A2-and-3-studies-of-patients-with-irritable-bowel-syndrome-with%C3%A2-diarrhea
#6
Reginald V Fant, Jack E Henningfield, Brooks D Cash, Leonard S Dove, Paul S Covington
BACKGROUND & AIMS: Eluxadoline is approved by the Food and Drug Administration for the treatment of adults with irritable bowel syndrome with diarrhea (IBS-D). Eluxadoline is a locally acting mixed μ-opiod and κ-opioid receptor agonist and δ-opioid receptor antagonist. The abuse potential of eluxadoline was evaluated as part of the Phase 2 and 3 clinical trials assessing the efficacy, safety, and tolerability of the drug. METHODS: One Phase 2 (IBS-2001) and two Phase 3 (IBS-3001 and IBS-3002) randomized controlled trials enrolled patients meeting Rome III criteria for IBS-D...
February 3, 2017: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/27922029/safety-of-eluxadoline-in-patients-with-irritable-bowel-syndrome-with-diarrhea
#7
RANDOMIZED CONTROLLED TRIAL
Brooks D Cash, Brian E Lacy, Philip S Schoenfeld, Leonard S Dove, Paul S Covington
OBJECTIVES: Eluxadoline is a mixed μ-opioid receptor (OR) and κ-OR agonist and δ-OR antagonist, approved for the treatment of irritable bowel syndrome with diarrhea (IBS-D). This analysis evaluated the safety and tolerability of eluxadoline 75 and 100 mg twice daily (BID) in one Phase 2 (IBS-2001) and two Phase 3 (IBS-3001 and IBS-3002) studies. METHODS: Adults with IBS-D (Rome III criteria) were randomized to placebo or eluxadoline (75 or 100 mg) BID for 12 (IBS-2001), 26 (IBS-3002), or 52 (IBS-3001) weeks...
February 2017: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/27875419/new-treatment-options-for-irritable-bowel-syndrome-with-predominant-diarrhea
#8
H Christian Weber
PURPOSE OF REVIEW: Irritable bowel syndrome (IBS) is a highly prevalent gastrointestinal disorder with negative impact on quality of life and it represents a substantial economic burden on healthcare cost. The medical management of IBS remains largely symptomatic. This review provides an update related to the most recently published diagnostic Rome IV criteria for IBS and clinical trial data for novel treatment modalities in IBS targeting the peripheral opioid receptors of the enteric nervous system and the gut microbiota...
February 2017: Current Opinion in Endocrinology, Diabetes, and Obesity
https://www.readbyqxmd.com/read/27647873/abuse-potential-and-pharmacodynamic-characteristics-of-oral-and-intranasal-eluxadoline-a-mixed-%C3%AE-and-%C3%AE%C2%BA-opioid-receptor-agonist-and-%C3%AE-opioid-receptor-antagonist
#9
RANDOMIZED CONTROLLED TRIAL
N Levy-Cooperman, G McIntyre, L Bonifacio, M McDonnell, J M Davenport, P S Covington, L S Dove, E M Sellers
Drugs with μ-opioid receptor (OR) activity can be associated with abuse and misuse. The peripherally acting mixed μ-OR and κ-OR agonist and δ-OR antagonist eluxadoline is approved in the United States for the treatment of irritable bowel syndrome with diarrhea. In two separate crossover studies, we evaluated the oral and intranasal abuse potential of eluxadoline versus placebo and the active control oxycodone. Healthy recreational opioid users received eluxadoline 100, 300, and 1000 mg, oxycodone 30 and 60 mg, and placebo (oral study), or eluxadoline 100 and 200 mg, oxycodone 15 and 30 mg, and placebos matched to eluxadoline and oxycodone (intranasal study)...
December 2016: Journal of Pharmacology and Experimental Therapeutics
https://www.readbyqxmd.com/read/27642742/-chronic-non-infectious-diarrhea-diagnostics-and-therapy
#10
REVIEW
Korinna Ulbricht, Peter Layer, Viola Andresen
Chronic, non-infectious diarrhea can be caused by a variety of gastrointestinal diseases. In anamnesis, it is important to take accompanying warning symptoms and specific triggers into account. The fecal inflammatory marker calprotectin may help differentiating between organic and functional gastrointestinal disorders, but it is not specific. Among other options, gelling fibres, Loperamide and Cholestyramine as well as probiotics are available for the symptomatic treatment of chronic diarrhea. For long-term treatment of chronic diarrhea with the enkephalinase inhibitor racecadotril, which is approved for acute diarrhea, only limited data are available...
September 2016: Deutsche Medizinische Wochenschrift
https://www.readbyqxmd.com/read/27494245/the-role-of-mop-and-dop-receptors-in-treatment-of-diarrhea-predominant-irritable-bowel-syndrome
#11
Agata Jarmuż, Martyna Banaszek, Karolina Leń, Martin Storr, Marta Zielińska, Jakub Fichna
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a frequent functional disorder of the gastrointestinal (GI) tract affecting nearly one fifth of the worldwide population. IBS-D is associated with numerous symptoms including diarrhea, bloating, abdominal pain and discomfort, which significantly reduce patients' quality of life. Due to a complex and unclear pathogenesis, effective therapy against IBS-D has not been developed yet. Nowadays, treatment is focused on non-pharmacological (e.g. changes in diet and life style) and pharmacological (e...
August 4, 2016: Mini Reviews in Medicinal Chemistry
https://www.readbyqxmd.com/read/27494159/review-the-role-of-mop-and-dop-receptors-in-treatment-of-diarrheapredominant-irritable-bowel-syndrome
#12
REVIEW
Agata Jarmuż, Marta Zielińska, Karolina Leń, Martyna Banaszek, Martin Storr, Jakub Fichna
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a frequent functional disorder of the gastrointestinal (GI) tract affecting nearly one fifth of the worldwide population. IBS-D is associated with numerous symptoms including diarrhea, bloating, abdominal pain and discomfort, which significantly reduce patients' quality of life. Due to a complex and unclear pathogenesis, effective therapy against IBS-D has not been developed yet. Nowadays, treatment is focused on non-pharmacological (e.g. changes in diet and life style) and pharmacological (e...
2016: Mini Reviews in Medicinal Chemistry
https://www.readbyqxmd.com/read/27436200/diarrhea-predominant-irritable-bowel-syndrome-diagnosis-etiology-and-new-treatment-considerations
#13
REVIEW
Brian E Lacy, Julie C Moreau
PURPOSE: To provide an overview of irritable bowel syndrome (IBS), specifically the efficacy and tolerability of treatment options for diarrhea-predominant IBS (IBS-D). DATA SOURCES: Research articles available via PubMed were reviewed. CONCLUSIONS: IBS is a chronic multifactorial disorder that has a negative impact on patient-related quality of life. Genetic factors, psychosociologic factors, alterations in the gut microbiota, and changes in immune, motor, and sensory responses to various stimuli all may be involved in the development of IBS...
July 2016: Journal of the American Association of Nurse Practitioners
https://www.readbyqxmd.com/read/27331917/modern-management-of-irritable-bowel-syndrome-more-than-motility
#14
REVIEW
Jan Tack, Tim Vanuytsel, Maura Corsetti
In the treatment of irritable bowel syndrome (IBS), loperamide seems efficacious for diarrhea and ispaghula for constipation, while musculotropic spasmolytics may relieve abdominal pain. Antidepressants were found to be efficacious for abdominal pain, but their tolerance may be problematic and the therapeutic effect varied largely between trials. While meta-analyses suggest efficacy of probiotics as a group, the quality of the trials is often suboptimal and there is large variability. Lubiprostone, a chloride channel activator, and linaclotide, a guanylyl cyclase-C agonist, showed favorable effects on multiple symptoms in IBS with constipation...
2016: Digestive Diseases
https://www.readbyqxmd.com/read/27267380/eluxadoline-for-the-treatment-of-diarrhoea-predominant-irritable-bowel-syndrome
#15
REVIEW
Emidio Scarpellini, Lucrezia Laterza, Gianluca Ianiro, Jan Tack, Ludovico Abenavoli, Antonio Gasbarrini
INTRODUCTION: Irritable bowel syndrome (IBS) treatment is challenging physicians because of its multifactorial physiopathology. In particular, abdominal pain and diarrhea management lack one unique effective pharmacological remedy. Opioid receptors, present in the central nervous system (CNS) and the enteric nervous system (ENS), are involved in visceral sensitivity and gastrointestinal motility control. To date only a few opioid receptor modulators are currently in use for the treatment of IBS but with dosage limitations due to the early development of severe constipation...
July 2016: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/27257381/clinical-potential-of-eluxadoline-in-the-treatment-of-diarrhea-predominant-irritable-bowel-syndrome
#16
REVIEW
Aleksandra Sobolewska-Włodarczyk, Marcin Włodarczyk, Martin Storr, Jakub Fichna
Diarrhea-predominant irritable bowel syndrome (IBS-D) belongs to the group of functional gastrointestinal disorders and is characterized by abdominal pain in conjunction with diarrhea. The incidence of IBS-D is currently increasing, leading to a heavy economic burden for patients and health care systems worldwide. Recent studies suggest eluxadoline as an attractive new tool for the treatment of patients with IBS-D. Eluxadoline is an orally active μ- and κ-opioid receptor agonist and δ-opioid receptor antagonist, with powerful antidiarrheal and analgesic activity...
2016: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/27134665/new-and-emerging-therapies-for-the-treatment-of-irritable-bowel-syndrome-an-update-for-gastroenterologists
#17
REVIEW
Amy E Foxx-Orenstein
Irritable bowel syndrome is a functional bowel disorder with gastrointestinal symptoms (e.g. abdominal pain, straining, urgency, incomplete evacuation, nausea, and bloating) that occur alongside bowel function alterations (i.e. constipation, diarrhea, or both). Patients with irritable bowel syndrome may also experience comorbid anxiety and depression. Irritable bowel syndrome is common, with a prevalence estimated between 3% and 28%, affecting patient health and quality of life. Patients with moderate or severe irritable bowel syndrome generally seek medical care, whereas those with milder symptoms may choose self-management...
May 2016: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/26971716/update-on-the-management-of-diarrhea-predominant-irritable-bowel-syndrome-focus-on-rifaximin-and-eluxadoline
#18
REVIEW
Anastasia Rivkin, Sergey Rybalov
Diarrhea-predominant irritable bowel syndrome (IBS-D) is one of the most common diagnoses made by gastroenterologists. Current pharmacologic treatments for IBS-D include fiber supplements, antidiarrheal over-the-counter medications, probiotics, antispasmodics, antidepressants, and a 5-hydroxytryptophan 3 receptor antagonist. All of these options have limited efficacy in managing IBS-D. Rifaximin, a nonabsorbable antibiotic, has been evaluated in patients with IBS-D. In two randomized, double-blind, placebo-controlled phase III trials evaluating rifaximin 550 mg by mouth 3 times/day for 14 days, the primary efficacy end point was achieved by 9% more patients randomized to the rifaximin group compared with placebo (40...
March 2016: Pharmacotherapy
https://www.readbyqxmd.com/read/26929659/diagnosis-and-treatment-of-diarrhea-predominant-irritable-bowel-syndrome
#19
REVIEW
Brian E Lacy
Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders worldwide. The economic impact of IBS on the health care system is substantial, as is the personal impact on patients. Patients with diarrhea-predominant IBS (IBS-D) comprise a substantial proportion of the overall IBS population. Primary care providers are often the first point of contact for patients with IBS-D and can accurately diagnose IBS after a careful history and examination without extensive diagnostic tests. Several pharmacologic treatments (eg, loperamide, alosetron, and antidepressants) and non-pharmacologic treatments (eg, dietary modification and probiotics) are available for IBS-D, but restrictions on use (eg, alosetron) or the lack of controlled trial data showing reductions in both global and individual IBS-D symptoms (eg, bloating, pain and stool frequency) emphasize the need for alternative treatment options...
2016: International Journal of General Medicine
https://www.readbyqxmd.com/read/26789872/eluxadoline-for-irritable-bowel-syndrome-with-diarrhea
#20
RANDOMIZED CONTROLLED TRIAL
Anthony J Lembo, Brian E Lacy, Marc J Zuckerman, Ron Schey, Leonard S Dove, David A Andrae, J Michael Davenport, Gail McIntyre, Rocio Lopez, Lisa Turner, Paul S Covington
Background Effective and safe treatments are needed for patients who have irritable bowel syndrome (IBS) with diarrhea. We conducted two phase 3 trials to assess the efficacy and safety of eluxadoline, a new oral agent with mixed opioid effects (μ- and κ-opioid receptor agonist and δ-opioid receptor antagonist), in patients with IBS with diarrhea. Methods We randomly assigned 2427 adults who had IBS with diarrhea to eluxadoline (at a dose of 75 mg or 100 mg) or placebo twice daily for 26 weeks (IBS-3002 trial) or 52 weeks (IBS-3001 trial)...
January 21, 2016: New England Journal of Medicine
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