title: Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice.
abstract: Tetrahydrocannabinol:cannabidiol (THC:CBD) oromucosal spray (Sativex®) is an add-on therapy for moderate-to-severe multiple sclerosis (MS)-related drug-resistant spasticity (MSS).
  
  
  
  The MOVE-2 EU study collected data from everyday clinical practice concerning the effectiveness and tolerability of THC:CBD.
  
  
  
  This was an observational, prospective, multicentre, non-interventional study. Patients with resistant MSS prescribed add-on THC:CBD oromucosal spray according to approved labelling, were followed for 3 months. After 1 month, only responders (≥20% improvement in spasticity) continued treatment. The main endpoints were the evolution of MSS and associated symptoms, quality of life (QoL) and tolerability.
  
  
  
  Four hundred and thirty three patients (55% female) were recruited (98% in Italy). The mean duration of MSS was 7.4 years and baclofen was used by 78.1% of participants. Three hundred and forty nine participants continued with THC:CBD oromucosal spray after 1 month, and 281 after 3 months. THC:CBD mean dosage was 6 sprays/day. MSS scores and spasticity-related symptoms (spasms, fatigue, pain, sleep quality and bladder dysfunction) were significantly improved by THC:CBD at 3 months, as were activities of daily living, and QoL (EQ-5D VAS). Adverse events, none of which were severe or serious, were reported by 10.4% of patients.
  
  
  
  In everyday clinical practice, THC:CBD oromucosal spray provided symptomatic relief of MSS and related troublesome symptoms.
authors.affiliation: University of Lille, CHU Lille, LIRIC-INSERM U995, FHU Imminent, Lille, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Vermersch
authors.forename: Maria
authors.initials: M
authors.lastname: Trojano
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D001418:Baclofen / Q000627:therapeutic use; D002185:Cannabidiol; D013759:Dronabinol; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000150:complications* / Q000188:drug therapy; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology*; D058993:Oral Sprays; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011788:Quality of Life
chemical_list: D004338:Drug Combinations; D058993:Oral Sprays; D010936:Plant Extracts; D002185:Cannabidiol; D013759:Dronabinol; D001418:Baclofen; C587251:nabiximols