title: Evidence for the efficacy and effectiveness of THC-CBD oromucosal spray in symptom management of patients with spasticity due to multiple sclerosis.
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.
authors.affiliation: Department of Neurology, University of Rostock, Gehlsheimer Straße 20, D-18147 Rostock, Germany.
authors.forename: Uwe K
authors.initials: UK
authors.lastname: Zettl
authors.affiliation: Department of Neurology, University of Rostock, Germany.
authors.forename: Paulus
authors.initials: P
authors.lastname: Rommer
authors.affiliation: Saproma, Roetgen, Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Hipp
authors.affiliation: Department of Neurology, University of Rostock, Germany Oscar-Langendorff-Institute of Physiology, University of Rostock, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Patejdl
keywords: CBD; THC; cannabinoids; multiple sclerosis; nabiximols; spasticity