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Review
. 2016 Jan;9(1):9-30.
doi: 10.1177/1756285615612659.

Evidence for the efficacy and effectiveness of THC-CBD oromucosal spray in symptom management of patients with spasticity due to multiple sclerosis

Uwe K Zettl  1 , Paulus Rommer  2 , Petra Hipp  3 , Robert Patejdl  4
Affiliations
Review

Evidence for the efficacy and effectiveness of THC-CBD oromucosal spray in symptom management of patients with spasticity due to multiple sclerosis

Uwe K Zettl et al. Ther Adv Neurol Disord. 2016 Jan.

Abstract

Spasticity, one of the main symptoms of multiple sclerosis (MS), can affect more than 80% of MS patients during the course of their disease and is often not treated adequately. δ-9-Tetrahydrocannabinol-cannabidiol (THC-CBD) oromucosal spray is a plant-derived, standardized cannabinoid-based oromucosal spray medicine for add-on treatment of moderate to severe, resistant multiple sclerosis-induced spasticity. This article reviews the current evidence for the efficacy and safety, with dizziness and fatigue as the most common treatment-related adverse events, being mostly mild to moderate in severity. Results from both randomized controlled phase III studies involving about,1600 MS patients or 1500 patient-years and recently published studies on everyday clinical practice involving more than 1000 patients or more than,1000 patient-years are presented.

Keywords: CBD; THC; cannabinoids; multiple sclerosis; nabiximols; spasticity.

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Conflict of interest statement

Conflict of Interest Statement: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: U.Z. has received honoraria for lecturing, travel expenses for attending meetings and support for research from Almirall, Bayer, Biogen Idec, Merck Serono, Novartis, Sanofi Aventis and TEVA. P. H. provided editorial support with funding from Almirall Hermal GmbH, Reinbek, Germany. The content was written entirely independently of Almirall and suggestions from Almirall were not considered mandatory. All conclusions are expressions of the author’s scientific viewpoint. The other authors declare no conflicts of interest in preparing this article.

Figures

Figure 1.
Figure 1.
Endocannabinoid system and mode of action of cannabinoids. Endo- and phytocannabinoids mediate neuronal signaling. The neurotransmitters glutamate and γ-aminobutyric acid (GABA) are released after an action potential has induced calcium ions to flow into the axonal terminal bulb. Glutamate binding to its ionotropic receptor (iGluR) leads to membrane depolarization in the postsynaptic neuron and an excitatory signal. GABA binding to its receptor leads to an inhibitory signal. Synthesis of endocannabinoids (ECBs) is induced by the activation of postsynaptic metabotropic glutamate receptors (mGlu-R) and high cytoplasmic calcium levels. ECBs activate presynaptic G-protein-coupled CB1 receptors, thus inhibiting presynaptic calcium influx and neurotransmitter release. Tetrahydrocannabinol (THC) mimics the action of the ECB anandamide (Perez, J. Combined cannabinoid therapy via an oromucosal spray. Drugs of Today 2006; 42:495-501. Copyright© 2006-2014 Prous Science, S.A.U. or its licensors. All rights reserved. DOI NUMBER: 10.1358/dot.2006.42.8.1021517).
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