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Gastrointestinal (GI) Motility, Chronic Therapeutic Class Review
Gastrointestinal (GI) Motility, Chronic Therapeutic Class Review (TCR) March 7, 2019 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. March 2019 Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2019 Magellan Rx Management. All Rights Reserved. FDA-APPROVED INDICATIONS Drug Manufacturer Indication(s) alosetron (Lotronex®)1 generic, . -
Drug Development for the Irritable Bowel Syndrome: Current Challenges and Future Perspectives
REVIEW ARTICLE published: 01 February 2013 doi: 10.3389/fphar.2013.00007 Drug development for the irritable bowel syndrome: current challenges and future perspectives Fabrizio De Ponti* Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy Edited by: Medications are frequently used for the treatment of patients with the irritable bowel syn- Angelo A. Izzo, University of Naples drome (IBS), although their actual benefit is often debated. In fact, the recent progress in Federico II, Italy our understanding of the pathophysiology of IBS, accompanied by a large number of preclin- Reviewed by: Elisabetta Barocelli, University of ical and clinical studies of new drugs, has not been matched by a significant improvement Parma, Italy of the armamentarium of medications available to treat IBS. The aim of this review is to Raffaele Capasso, University of outline the current challenges in drug development for IBS, taking advantage of what we Naples Federico II, Italy have learnt through the Rome process (Rome I, Rome II, and Rome III). The key questions *Correspondence: that will be addressed are: (a) do we still believe in the “magic bullet,” i.e., a very selective Fabrizio De Ponti, Pharmacology Unit, Department of Medical and Surgical drug displaying a single receptor mechanism capable of controlling IBS symptoms? (b) IBS Sciences, University of Bologna, Via is a “functional disorder” where complex neuroimmune and brain-gut interactions occur Irnerio, 48, 40126 Bologna, Italy. and minimal inflammation is often documented: -
Current Neuropharmacology, 2016, 14, 842-856
842 Send Orders for Reprints to [email protected] Current Neuropharmacology, 2016, 14, 842-856 REVIEW ARTICLE ISSN: 1570-159X eISSN: 1875-6190 Impact Factor: Pathogenesis, Experimental Models and Contemporary Pharmacotherapy 3.753 of Irritable Bowel Syndrome: Story About the Brain-Gut Axis BENTHAM SCIENCE S.W. Tsang1, K.K.W. Auyeung1, Z.X. Bian2,3 and J.K.S. Ko1,3,* 1Teaching and Research Division, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China; 2Clinical Division, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China; 3Center for Cancer and Inflammation Research, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China Abstract: Background: Although the precise pathophysiology of irritable bowel syndrome (IBS) remains unknown, it is generally considered to be a disorder of the brain-gut axis, representing the disruption of communication between the brain and the digestive system. The present review describes advances in understanding the pathophysiology and experimental approaches in studying IBS, as well as providing an update of the therapies targeting brain-gut axis in the treatment of the disease. Methods: Causal factors of IBS are reviewed. Following this, the preclinical experimental models of IBS will be introduced. Besides, both current and future A R T I C L E H I S T O R Y therapeutic approaches of IBS will be discussed. J.K.S. Ko Received: September 24, 2015 Revised: February 07, 2016 Results: When signal of the brain-gut axis becomes misinterpreted, it may lead to dysregulation of both Accepted: March 22, 2016 central and enteric nervous systems, altered intestinal motility, increased visceral sensitivity and DOI: consequently contributing to the development of IBS. -
Guideline the 2017 Canadian Guideline for Opioids for Chronic
The 2017 Canadian Guideline for Opioids for Chronic Non-Cancer Pain Main editor Publishing Information Jason Busse Associate Professor, Department of Anesthesia, Associate v4.10 published on 29.10.2018 Professor, Department of Health Research Methods, Evidence and Impact McMaster University, HSC-2V9, 1280 Main St. West, Hamilton, Ontario, Canada, L8S 4K1 [email protected] National pain center 1 of 106 The 2017 Canadian 2017 Guideline Canadian for Opioids for Chronic Non-CancerGuideline Pain - National painfor center Opioids for Chronic Non-Cancer Pain Guideline Panel Members: Jason W. Busse (Chair), McMaster University, Canada Gordon H. Guyatt, McMaster University, Canada Alonso Carrasco, American Dental Association, USA Elie Akl, American University of Beirut, Lebanon Thomas Agoritsas, University Hospitals of Geneva, Switzerland Bruno da Costa, Florida International University, USA Per Olav Vandvik, Innlandet Hospital Trust-Division Gjøvik, Norway Peter Tugwell, University of Ottawa, Canada Sol Stern, private practice, Canada Lynn Cooper, Canadian Pain Coalition, Canada Chris Cull, Inspire by Example, Canada Gus Grant, College of Physicians and Surgeons of Nova Scotia, Canada Alfonso Iorio, McMaster University, Canada Nav Persaud, University of Toronto, Canada Joseph Frank, VA Eastern Colorado Health Care System, USA Guideline Steering Committee: Gordon H. Guyatt (Chair), Norm Buckley, Jason W. Busse, David Juurlink Clinical Expert Committee: Norm Buckley, Donna Buna, Gary Franklin, Chris Giorshev, Jeff Harris, Lydia Hatcher, Kurt Hegmann, Roman Jovey, David Juurlink, Priya Manjoo, Pat Morley-Forster, Dwight Moulin, Mark Sullivan Patient Advisory Committee:* Bart Bennett, Lynn Cooper, Chris Cull, Ada Giudice-Tompson, Deborah Ironbow, Pamela Jessen, Mechelle Kane, Andrew Koster, Sue Mace, Tracy L. Mercer, Kyle Neilsen, Ian Tregunna, Jen Watson * 3 members did not provide written consent to be listed Evidence Synthesis Team: Samantha Craigie, Jason W. -
The Role of Visceral Hypersensitivity in Irritable Bowel Syndrome: Pharmacological Targets and Novel Treatments
J Neurogastroenterol Motil, Vol. 22 No. 4 October, 2016 pISSN: 2093-0879 eISSN: 2093-0887 http://dx.doi.org/10.5056/jnm16001 JNM Journal of Neurogastroenterology and Motility Review The Role of Visceral Hypersensitivity in Irritable Bowel Syndrome: Pharmacological Targets and Novel Treatments Mohammad H Farzaei,1,2 Roodabeh Bahramsoltani,3 Mohammad Abdollahi,3,4* and Roja Rahimi5* 1Pharmaceutical Sciences Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran; 2Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran; 3Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran; 4Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran; and 5Department of Traditional Pharmacy, School of Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran Irritable bowel syndrome (IBS) is the most common disorder referred to gastroenterologists and is characterized by altered bowel habits, abdominal pain, and bloating. Visceral hypersensitivity (VH) is a multifactorial process that may occur within the peripheral or central nervous systems and plays a principal role in the etiology of IBS symptoms. The pharmacological studies on selective drugs based on targeting specific ligands can provide novel therapies for modulation of persistent visceral hyperalgesia. The current paper reviews the cellular and molecular mechanisms underlying therapeutic targeting for providing future drugs to protect or treat visceroperception and pain sensitization in IBS patients. There are a wide range of mediators and receptors participating in visceral pain perception amongst which substances targeting afferent receptors are attractive sources of novel drugs. Novel therapeutic targets for the management of VH include compounds which alter gut-brain pathways and local neuroimmune pathways. -
THE HARD TRUTH ABOUT PROKINETIC MEDICATION USE in PETS Introduction Pathophysiology/Etiology to That Observed in Dogs
VETTALK Volume 15, Number 04 American College of Veterinary Pharmacists THE HARD TRUTH ABOUT PROKINETIC MEDICATION USE IN PETS Introduction Pathophysiology/Etiology to that observed in dogs. It can be The moving topic of this Vet Talk As with most diseases in the veteri- due to a trichobezoar, dehydration, newsletter will be prokinetic medica- nary world, the etiology and patho- obesity, old age, diabetes, immobility, tions. The availability of information physiology of constipation are varied pain from trauma to the low back, on the many prokinetic agents is var- depending on the species being dis- bladder infection, or an anal sac infec- ied at best so an overall consensus of cussed, where in their gastrointestinal tion. In cases that are more chronic, prokinetic medications will be as- tract the problem is occurring, and underlying disease such as colitis or sessed in this article, hopefully giving any accompanying comorbid condi- Irritable Bowel Syndrome (IBS) may better insight to practitioners about tions. be the culprit. On the other hand, the which agents to use in their patients. cause may be idiopathic which is Canines: In man’s best friend, consti- frustrating for both veterinarian and Prevalence pation has many origins. A dog’s patient since this form is most diffi- Chronic constipation and gastroin- digestive tract itself is complex but cult to treat. testinal stasis are highly debilitating ultimately the mass movements and conditions that not only affect human haustral contractions from the large Equines: Despite their large size, patients but our four legged patients intestine (colon), propel feces into the horses have incredibly delicate diges- as well! Though this condition is rectum stimulating the internal anal tive systems. -
X351endoscopic Ultrasonography and Computed
3rd UEGWOslo 1994 A9 viding the patients according to the criteria of Colin-Jones gave very small -8%, 95% Cl -22% to +7%). The response was unrelated to subgroups of groups and offered no further information. The effects of the drug on individ- dyspepsia: effects of CIS, NIZ and PLA, respectively, in R: 57%, 60%, and ual symptoms, likewise, did not reach significance. 74%, in D: 61%, 55%, and 55%, in U: 67%, 50%, and 60% and in I: 67%, Gut: first published as 10.1136/gut.35.4_Suppl.A9 on 1 January 1994. Downloaded from Conclusion: Our results do not support a role for gastric acid production 50%, and 64%. in generation of functional upper dyspepsia and do not warrant prescription Conclusion: effects of a 2-week course of CIS or NIZ in unselected patients of Omeprazole to patients suffering from non-ulcer dyspepsia. with NUD were not superior to effects of PLA. Symptom grouping was not predictive of response to therapy. 3 Effects of Fedotozine in Chronic Idiopathic Dyspepsia: A Double Blind, Placebo Controlled 351EndoscopicX Ultrasonography and Computed Multicentre Study Tomography in Diagnosis and Staging of Pancreatic Tumors: Comparison with Surgery J.P Galmiche 1, C. de Meynard 2, J.L. Abitbol 2, B. Scherrer2, B. Fraitag 2. 1 Service d'H6pato-Gastroent6rologie, CHU Nord, BP 1005, 44035 Nantes; J.M. Aubertin 1, 0. Marty1, J.L. Bouillot2, A. Hernigou3, F. Bloch 1, J.P 2 Institut de Recherche Jouveinal, BP 100, 94265 Fresnes Petite 1. 1 Dept of Gastroenterology, H6pital Broussais, 75014 Paris, France; 2 Dept ofSurgery, H6pital Broussais, 75014 Paris, France; 3 Dept of Safety and efficacy of fedotozine (F), a peripheral K agonist, were assessed Radiology, H6pital Broussais, 75014 Paris, France versus placebo (P), in a double blind multicentre study conducted in France by hospital and private gastroenterologists. -
Keeping up with FDA Drug Approvals: 60 New Drugs in 60 Minutes Elizabeth A
Keeping Up with FDA Drug Approvals: 60 New Drugs in 60 Minutes Elizabeth A. Shlom, PharmD, BCPS Senior Vice President & Director Clinical Pharmacy Program | Acurity, Inc. Privileged and Confidential April 10, 2019 Privileged and Confidential Program Objectives By the end of the presentation, the pharmacist or pharmacy technician participant will be able to: ▪ Identify orphan drugs and first-in-class medications approved by the FDA in 2018. ▪ List five new drugs and their indications. ▪ Identify the place in therapy for three novel monoclonal antibodies. ▪ Discuss at least two new medications that address public health concerns. Dr. Shlom does not have any conflicts of interest in regard to this presentation. Both trade names and generic names will be discussed throughout the presentation Privileged and Confidential 2018 NDA Approvals (NMEs/BLAs) ▪ Lutathera (lutetium Lu 177 dotatate) ▪ Braftovi (encorafenib) ▪ Vizimpro (dacomitinib) ▪ Biktarvy (bictegravir, emtricitabine, ▪ TPOXX (tecovirimat) ▪ Libtayo (cemiplimab-rwic) tenofovir, ▪ Tibsovo (ivosidenib) ▪ Seysara (sarecycline) alafenamide) ▪ Krintafel (tafenoquine) ▪ Nuzyra (omadacycline) ▪ Symdeko (tezacaftor, ivacaftor) ▪ Orilissa (elagolix sodium) ▪ Revcovi (elapegademase-lvir) ▪ Erleada (apalutamide) ▪ Omegaven (fish oil triglycerides) ▪ Tegsedi (inotersen) ▪ Trogarzo (ibalizumab-uiyk) ▪ Mulpleta (lusutrombopag) ▪ Talzenna (talazoparib) ▪ Ilumya (tildrakizumab-asmn) ▪ Poteligeo (mogamulizumab-kpkc) ▪ Xofluza (baloxavir marboxil) ▪ Tavalisse (fostamatinib disodium) ▪ Onpattro (patisiran) -
The Pharmacology of Prokinetic Agents and Their Role in the Treatment of Gastrointestinal Disorders
The Pharmacology of ProkineticAgents IJGE Issue 4 Vol 1 2003 Review Article The Pharmacology of Prokinetic Agents and Their Role in the Treatment of Gastrointestinal Disorders George Y. Wu, M.D, Ph.D. INTRODUCTION Metoclopramide Normal peristalsis of the gut requires complex, coordinated neural and motor activity. Pharmacologic Category : Gastrointestinal Abnormalities can occur at a number of different Agent. Prokinetic levels, and can be caused by numerous etiologies. This review summarizes current as well as new Symptomatic treatment of diabetic gastric agents that show promise in the treatment of stasis gastrointestinal motility disorders. For these Gastroesophageal reflux e conditions, the most common medications used in s Facilitation of intubation of the small the US are erythromycin, metoclopramide, and U intestine neostigmine (in acute intestinal pseudo- Prevention and/or treatment of nausea and obstruction). A new prokinetic agent, tegaserod, vomiting associated with chemotherapy, has been recently approved, while other serotonin radiation therapy, or post-surgery (1) agonist agents (prucalopride, YM-31636, SK-951, n ML 10302) are currently undergoing clinical o Blocks dopamine receptors in chemoreceptor i t studies. Other prokinetics, such as domperidone, c trigger zone of the CNS (2) A are not yet approved in the US, although are used in f Enhances the response to acetylcholine of o other countries. tissue in the upper GI tract, causing enhanced m s i n motility and accelerated gastric emptying a DELAYED GASTRIC EMPTYING OR h without stimulating gastric, biliary, or c G A S T R O E S O P H A G E A L R E F L U X e pancreatic secretions. -
Irritable Bowel Syndrome : Pathophysiology, Symptoms and Biomarkers
Irritable bowel syndrome : pathophysiology, symptoms and biomarkers Citation for published version (APA): Mujagic, Z. (2015). Irritable bowel syndrome : pathophysiology, symptoms and biomarkers. Uitgeverij BOXPress || Proefschriftmaken.nl. https://doi.org/10.26481/dis.20151221zm Document status and date: Published: 01/01/2015 DOI: 10.26481/dis.20151221zm Document Version: Publisher's PDF, also known as Version of record Please check the document version of this publication: • A submitted manuscript is the version of the article upon submission and before peer-review. There can be important differences between the submitted version and the official published version of record. People interested in the research are advised to contact the author for the final version of the publication, or visit the DOI to the publisher's website. • The final author version and the galley proof are versions of the publication after peer review. • The final published version features the final layout of the paper including the volume, issue and page numbers. Link to publication General rights Copyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright owners and it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights. • Users may download and print one copy of any publication from the public portal for the purpose of private study or research. • You may not further distribute the material or use it for any profit-making activity or commercial gain • You may freely distribute the URL identifying the publication in the public portal. If the publication is distributed under the terms of Article 25fa of the Dutch Copyright Act, indicated by the “Taverne” license above, please follow below link for the End User Agreement: www.umlib.nl/taverne-license Take down policy If you believe that this document breaches copyright please contact us at: [email protected] providing details and we will investigate your claim. -
Marketing Authorisations Granted in December 2020
Marketing authorisations granted in December 2020 PL Number Grant Date MA Holder Licensed Name(s) Active Ingredient Quantity Units Legal Status Territory PL 14251/0100 01/12/2020 MANX HEALTHCARE LIMITED COLCHICINE 500 MICROGRAMS TABLETS COLCHICINE 0.500 MILLIGRAMS POM UK PL 34424/0050 02/12/2020 KEY PHARMACEUTICALS LIMITED SPIRONOLACTONE 25MG FILM-COATED TABLETS SPIRONOLACTONE 25 MILLIGRAMS POM UK PL 34424/0051 02/12/2020 KEY PHARMACEUTICALS LIMITED SPIRONOLACTONE 50MG FILM-COATED TABLETS SPIRONOLACTONE 50 MILLIGRAMS POM UK PL 34424/0052 02/12/2020 KEY PHARMACEUTICALS LIMITED SPIRONOLACTONE 100MG FILM-COATED TABLETS SPIRONOLACTONE 100 MILLIGRAMS POM UK PL 36282/0021 03/12/2020 RIA GENERICS LIMITED COLCHICINE 500 MICROGRAM TABLETS COLCHICINE 500 MICROGRAMS POM UK PL 39352/0439 03/12/2020 KOSEI PHARMA UK LIMITED FROVATRIPTAN 2.5 MG FILM-COATED TABLETS FROVATRIPTAN SUCCINATE MONOHYDRATE 2.5 MILLIGRAMS POM UK PL 31750/0174 04/12/2020 SUN PHARMACEUTICAL INDUSTRIES EUROPE BV CETRORELIX SUN 0.25 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE CETRORELIX ACETATE 0.25 MILLIGRAMS PER MILLILITRE POM UK PL 34424/0054 04/12/2020 KEY PHARMACEUTICALS LIMITED ALIMEMAZINE TARTRATE 10MG FILM COATED TABLETS ALIMEMAZINE TARTRATE 10.00 MILLIGRAMS POM UK PL 17780/0858 07/12/2020 ZENTIVA PHARMA UK LIMITED FINGOLIMOD ZENTIVA 0.5 MG HARD CAPSULES FINGOLIMOD HYDROCHLORIDE 0.56 MILLIGRAMS POM UK PL 01502/0113 08/12/2020 HAMELN PHARMA LTD AMIODARONE HYDROCHLORIDE 20 MG/ML SOLUTION FOR INFUSION AMIODARONE HYDROCHLORIDE 20 MILLIGRAMS POM UK PL 16786/0006 08/12/2020 -
Prucalopride (SHP555) Update for Global Investors
Prucalopride (SHP555) Update for Global Investors March 7, 2018 STATEMENTS REGARDING PRUCALOPRIDE SUBJECT TO REGULATORY APPROVAL - INTENDED FOR INVESTOR AUDIENCE ONLY Prucalopride - Introduction U.S. FDA Accepts New Drug Application for Prucalopride (SHP555) for Chronic Idiopathic Constipation (CIC) • Prucalopride is an investigational product for the treatment of chronic idiopathic constipation in adults in the U.S. • The product is investigational. The U.S. FDA accepted submission of Shire’s NDA and the PDUFA date is on or around December 21, 2018 • Shire does not know when or if FDA will approve prucalopride • Shire cannot predict the content of the labeling for prucalopride in the event of FDA approval • This presentation updates investors on Shire’s current development plan for prucalopride 2 STATEMENTS REGARDING PRUCALOPRIDE SUBJECT TO REGULATORY APPROVAL - INTENDED FOR INVESTOR AUDIENCE ONLY Prucalopride - Summary U.S. FDA Accepts New Drug Application for Prucalopride (SHP555) for Chronic Idiopathic Constipation (CIC) • Reinforces Shire’s long-standing heritage in gastrointestinal (GI) conditions and deep customer relationships and in-house capabilities • Strong addition to GI franchise, which includes LIALDA, GATTEX and provides bridge to pipeline assets such as SHP621 and SHP647 • If approved, prucalopride will be the only readily available 5-HT4 agonist1 in the U.S. to treat CIC in adults • CIC affects an estimated 35 million people in the U.S.2,3* Many patients are dissatisfied with or do not respond to current therapies4 • Efficacy and safety evaluated in five main Phase 3 and one Phase 4 double-blind, placebo-controlled clinical trials5,6 • NDA submission includes real-world evidence from an observational, pharmacoepidemiology cardiovascular safety study7 *This represents ~14% of the U.S.