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      Health Authorities Data Collection of THC:CBD Oromucosal Spray (L'Agenzia Italiana del Farmaco Web Registry): Figures after 1.5 Years

      review-article
      *
      European Neurology
      S. Karger AG
      THC:CBD oromucosal spray, AIFA registry, Tolerability, Effectiveness, Multiple sclerosis spasticity

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          Abstract

          Background: In Italy, all prescriptions for THC:CBD oromucosal spray for treatment of multiple sclerosis (MS) spasticity are linked to the official Agenzia Italiana del Farmaco (AIFA) web-based registry, which tracks the effectiveness and tolerability of medications in a prospective and observational manner. Methods: AIFA e-registry data for THC:CBD oromucosal spray collected between January 2014 and February 2015 for 1,534 patients from 30 large Italian specialized MS centres were compiled. Patients had a long disease history (17.6 ± 8.6 years) and significant impairment (mean Expanded Disability Status Scale score 6.4 ± 1.2). MS spasticity was evaluated using the 0-10 numerical rating scale (NRS). Results: After the first month titration and trial period, 61.9% of patients achieved sufficient improvement in spasticity (≥20% NRS) to qualify for continued treatment. After 6 months, clinically meaningful ≥30% NRS improvement was recorded in 40.2% of patients continuing with treatment. Spasticity-associated symptoms such as cramps and nocturnal spasms improved in most responding patients. Mean reported doses of THC:CBD oromucosal spray (6.2-6.7 sprays/day) were lower than those reported in clinical trials. Adverse events (mainly mild to moderate) were reported by 15% of patients; no new safety concerns beyond the approved label were identified. Conclusion: The results of the AIFA e-registry analysis align with those of other THC:CBD observational projects and reaffirm the characteristics of this therapeutic option in the management of treatment-resistant MS spasticity, a frequently overlooked symptom.

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          Author and article information

          Journal
          ENE
          Eur Neurol
          10.1159/issn.0014-3022
          European Neurology
          S. Karger AG
          978-3-318-05852-9
          0014-3022
          1421-9913
          2016
          February 2016
          23 February 2016
          : 75
          : Suppl 1
          : 9-12
          Affiliations
          Department G.F. Ingrassia, Section of Neurosciences, University of Catania, Catania, Italy
          Author notes
          *Professor Francesco Patti, G.F. Ingrassia Department, Neuroscience Section, First Neurology Clinic Multiple Sclerosis Centre Sicilia Region, University Hospital Catania, Via Santa Sofia 78, IT-95123 Catania (Italy), E-Mail patti@unict.it
          Article
          444236 Eur Neurol 2016;75(suppl 1):9-12
          10.1159/000444236
          26901344
          85a91172-8c7b-4135-b6e7-60673f002c6d
          © 2016 S. Karger AG, Basel

          Copyright: 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. 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 changes 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. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication 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.

          History
          Page count
          Tables: 4, References: 6, Pages: 4
          Categories
          Review

          Geriatric medicine,Neurology,Cardiovascular Medicine,Neurosciences,Clinical Psychology & Psychiatry,Public health
          THC:CBD oromucosal spray,Multiple sclerosis spasticity,Effectiveness,AIFA registry,Tolerability

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