THC:CBD Daily Practice Evidence in MS Spasticity Management: The Moment of Large Databases

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1 THC:CBD Daily Practice Evidence in MS Spasticity Management: The Moment of Large Databases Almirall-Sponsored Satellite Symposium of the 31 st Congress of the European Committee for Treatment and Research in Multiple Sclerosis, 7 10 October 2015, Barcelona, Spain Guest Editor/Chair Maria Trojano, Bari Basel Freiburg Paris London New York Chennai New Delhi Bangkok Beijing Shanghai Tokyo Kuala Lumpur Singapore Sydney

2 Disclosure Statement Guest Editor Maria Trojano reports for the last year personal compensation as a consultant or speaker from Almirall, Bayer-Schering, Biogen Idec, Merck-Serono, Novartis, Sanofi Aventis, and Teva; research grants paid to her institution from Biogen Idec, Merck-Serono, Novartis and Teva. This publication was sponsored by Almirall. S. Karger Medical and Scientific Publishers Basel Freiburg Paris London New York Chennai New Delhi Bangkok Beijing Shanghai Tokyo Kuala Lumpur Singapore Sydney Disclaimer The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publisher and the editor(s). The appearance of advertisements in the journal is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements. Drug Dosage The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any change in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center (see General Information ). Copyright 2016 by S. Karger AG, Basel P.O. Box, CH 4009 Basel (Switzerland) e-isbn

3 Vol. 75, Suppl. 1, 2016 Contents V Foreword Trojano, M. (Bari, Italy) Reviews 1 THC:CBD in Daily Practice: Available Data from UK, Germany and Spain Fernández, Ó. (Málaga, Spain) 4 THC:CBD Observational Study Data: Evolution of Resistant MS Spasticity and Associated Symptoms Trojano, M. (Bari, Italy) 9 Health Authorities Data Collection of THC:CBD Oromucosal Spray (L Agenzia Italiana del Farmaco Web Registry): Figures after 1.5 Years Patti, F. (Catania, Italy) 2016 S. Karger AG, Basel III

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5 Eur Neurol 2016;75(suppl 1):V DOI: / Published online: February 23, 2016 Foreword Resistance to first-line treatment is common in patients with multiple sclerosis (MS) spasticity and frequently worsens other spasticity-associated symptoms such as mobility, pain, bladder dysfunction and sleep disorders, thus causing a combined detrimental effect on patients daily lives. Sativex oromucosal spray, a cannabinoid-based medicine with a balanced ratio of tetrahydrocannabinol (THC) and cannabidiol (CBD), has become available progressively across Europe since 2010 for symptomatic treatment of treatment-resistant MS spasticity. The efficacy and tolerability of THC:CBD oromucosal spray were demonstrated in an extensive clinical development programme of randomized controlled trials (RCTs), which led to its approval. Upon new medications reaching pharmacies, it is essential that data collection continues in order to confirm their risk benefit balance in daily practice use. Such data collection is generally achieved through observational studies. Over the past 5 years, and complementary to other supporting RCTs, several post-approval observational studies (safety regis- tries, non-interventional effectiveness studies) of THC:CBD oromucosal spray have been implemented in different countries of the European Union. In this symposium, data derived from large samples of patients who were treated with add-on THC:CBD oromucosal spray for moderate to severe treatment-resistant MS spasticity in the United Kingdom, Germany, Spain and Italy are presented. All studies were observational although the methodologies used to collect the data varied. Collectively, and in conjunction with the evidence from RCTs, we consider that the information generated from daily practice confirms the appropriate risk benefit balance of this innovative treatment option to relieve the burden of resistant MS spasticity. At a practical level, daily practice data can assist in identifying patients who may benefit most from treatment, provide guidance in tracking patients MS spasticity evolution and further reassure about the effectiveness, safety and tolerability of THC:CBD oromucosal spray during long-term use. Maria Trojano, Bari, Italy 2016 S. Karger AG, Basel /16/ V$39.50/0