Background: Clinical trials demonstrate the efficacy and tolerability of an intervention under experimental conditions, but information on use under daily practice conditions is required to confirm the effectiveness and safety of new management options. Summary: Clinical outcomes for THC:CBD oromucosal spray (Sativex®) in patients with treatment-resistant MS spasticity have been collected in post-marketing safety registries from the UK and Germany, a safety study from Spain and two observational studies from Germany, including one investigating its effects on driving ability. Collectively, findings from daily practice support the long-term effectiveness and safety of THC:CBD oromucosal spray. The proportion of patients with a clinically relevant response (≥30% improvement from baseline on the spasticity 0-10 Numerical Rating Scale) at 3 months was similar to that reported in a large enriched-design pivotal clinical trial (41 vs. 36%). There was no evidence of abuse/misuse or other adverse events of special interest with a cannabis-based medicine and no impairment of driving ability. In actual clinical practice, average daily doses were ∼25% lower than those used in clinical trials. Key Messages: Observational data and real world experience reinforce the efficacy and safety of THC:CBD oromucosal spray as reported in phase III clinical trials.

Keywords:
Driving ability, Observational studies, Patient registries, Safety, Spasticity, THC:CBD oromucosal spray
1.
Eltayb A, Etges T, Wright S: An observational post-approval registry study of patients prescribed Sativex®. Results from clinical practice. [Poster 1041]. Mult Scler 2013;(suppl 1): 74.558.
2.
Oreja-Guevara C, Blasco R, Casanova B, Ordás CM, Vila Silván C, Asensio D, Massana M: Observational safety study of THC/CBD oromucosal spray (Sativex) in multiple sclerosis patients with spasticity. Expert Opin Drug Saf 2014 [Submitted].
3.
Flachenecker P, Henze T, Zettl UK: Nabiximols (THC/CBD oromucosal spray, Sativex®) in clinical practice - results of a multicenter, non-interventional study (MOVE 2) in patients with multiple sclerosis spasticity. Eur Neurol 2014;71:271-279.
4.
Novotna A, Mares J, Ratcliffe S, Novakova I, Vachova M, Zapletalova O, Gasperini C, Pozzilli C, Cefaro L, Comi G, Rossi P, Ambler Z, Stelmasiak Z, Erdmann A, Montalban X, Klimek A, Davies P; Sativex Spasticity Study Group: A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols* (Sativex(®), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis. Eur J Neurol 2011;18:1122-1131.
5.
Freidel M, Tiel-Wilck K, Schreiber H, Lang M; on behalf of the Multiple Sclerosis specialists of the Neuro Trans Data group (NTD): Resistant multiple sclerosis spasticity (MSS) treatment with THC:CBD spray and effects on driving ability. [Poster 1111]. Mult Scler 2013;19(suppl 1):74-558.
© 2014 S. Karger AG, Basel
2014
Copyright / Drug Dosage / Disclaimer
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.
You do not currently have access to this content.