title: Long-term effectiveness and safety of nabiximols (tetrahydrocannabinol/cannabidiol oromucosal spray) in clinical practice.
abstract: BACKGROUND
  Nabiximols (Sativex®), in a cannabinoid-based oromucosal spray, is an add-on therapy option for patients with moderate to severe multiple sclerosis spasticity (MSS) resistant to other medications. The study objective was to provide long-term data on clinical outcomes, tolerability, quality of life and treatment satisfaction for MSS patients receiving nabiximols in routine care.
  
  
  METHODS
  This was the 12-month prolongation of the MOVE 2 study, an observational, prospective, multi-centre 3-month non-interventional study conducted in a routine care setting across Germany. Structured documentation forms, questionnaires and validated instruments were used for data collection.
  
  
  RESULTS
  In total, 52 patients were included in the effectiveness analysis after 12 months. The mean spasticity numerical rating scale (NRS, 0-10) score decreased significantly from 6.0 ± 1.8 points at MOVE 2 baseline to 4.8 ± 1.9 points after 1 month and remained on this level after 12 months (4.5 ± 2.0 points); in patients classified as 'initial responders' (≥20% NRS improvement after 1 month) similar results were found (baseline: 6.3 ± 1.4 points; after 1 month: 4.0 ± 1.0 points; after 12 months: 4.3 ± 1.9 points). The majority of patients (84%) did not report adverse events.
  
  
  CONCLUSIONS
  Real-life data confirm the long-term effectiveness and tolerability of nabiximols for the treatment of resistant MSS in everyday clinical practice.
authors.affiliation: Neurological Rehabilitation Centre Quellenhof, Bad Wildbad, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Flachenecker
authors.forename: Thomas
authors.initials: T
authors.lastname: Henze
authors.forename: Uwe K
authors.initials: UK
authors.lastname: Zettl
mesh_terms: D000328:Adult; D000368:Aged; D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects; D002185:Cannabidiol / Q000008:administration & dosage* / Q000009:adverse effects; D013759:Dronabinol / Q000008:administration & dosage* / Q000009:adverse effects; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000503:physiopathology; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000503:physiopathology; D058993:Oral Sprays; D017060:Patient Satisfaction; D011446:Prospective Studies; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D004338:Drug Combinations; D058993:Oral Sprays; D002185:Cannabidiol; D013759:Dronabinol; C587251:nabiximols