title: THC:CBD in Daily Practice: Available Data from UK, Germany and Spain.
abstract: BACKGROUND
  From the time Sativex (THC:CBD) oromucosal spray first became available in European Union countries in 2010 for the management of treatment-resistant multiple sclerosis (MS) spasticity, data from daily practice have been collected through various projects.
  
  
  METHODS
  A retrospective registry study and a prospective safety study of THC:CBD oromucosal spray are reported.
  
  
  RESULTS
  The most recent analysis of a retrospective registry established in the United Kingdom (UK), Germany and Switzerland, which collected safety data on more than 900 patients, has indicated a positive risk-benefit profile for THC:CBD oromucosal spray during long-term use. Long-term continuation rates were 68% (mean follow-up time 1 year) and the mean dose was 5.4 sprays/day. No new safety concerns were identified, and adverse events of special interest for a cannabis-based medicine were limited. The UK registry has since been closed but remains open in Germany and Switzerland. A prospective safety study undertaken in Spain involved 207 patients from 13 specialized MS centres who had been prescribed THC:CBD oromucosal spray. The findings aligned closely with the UK/German/Swiss registry data in terms of 1-year continuation rates (64.7%), mean daily dose (6.6 sprays/day) and safety profile, including no evidence of addiction, abuse or misuse.
  
  
  CONCLUSIONS
  The homogeneity between these observational studies supports the interest in THC:CBD oromucosal spray for management of MS spasticity in daily practice.
authors.affiliation: Institute of Clinical Neuroscience, Neurology Department, Hospital Regional Universitario Carlos Haya, FIMABIS, Malaga, Spain.
authors.forename: Óscar
authors.initials: Ó
authors.lastname: Fernández
mesh_terms: D000058:Accidental Falls; D002185:Cannabidiol; D003863:Depression / Q000139:chemically induced; D013759:Dronabinol; D004338:Drug Combinations; D005858:Germany; D006801:Humans; D002189:Marijuana Abuse / Q000209:etiology; D064086:Medical Marijuana / Q000627:therapeutic use*; D009103:Multiple Sclerosis / Q000150:complications / Q000188:drug therapy*; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D058993:Oral Sprays; D010936:Plant Extracts / Q000627:therapeutic use*; D011446:Prospective Studies; D012042:Registries; D012189:Retrospective Studies; D013030:Spain; D013557:Switzerland; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D004338:Drug Combinations; D064086:Medical Marijuana; D058993:Oral Sprays; D010936:Plant Extracts; D002185:Cannabidiol; D013759:Dronabinol; C587251:nabiximols