Long-term Effectiveness and Safety of Nabiximols (tetrahydrocannabinol/cannabidiol Oromucosal Spray) in Clinical Practice

Eur Neurol. 2014;72(1-2):95-102. doi: 10.1159/000360285. Epub 2014 Jun 18.

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.

Conclusion: Real-life data confirm the long-term effectiveness and tolerability of nabiximols for the treatment of resistant MSS in everyday clinical practice.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Analgesics / administration & dosage*
  • Analgesics / adverse effects
  • Cannabidiol / administration & dosage*
  • Cannabidiol / adverse effects
  • Dronabinol / administration & dosage*
  • Dronabinol / adverse effects
  • Drug Combinations
  • Female
  • Follow-Up Studies
  • Germany
  • Humans
  • Male
  • Middle Aged
  • Multiple Sclerosis / drug therapy*
  • Multiple Sclerosis / physiopathology
  • Muscle Spasticity / drug therapy*
  • Muscle Spasticity / physiopathology
  • Oral Sprays
  • Patient Satisfaction
  • Prospective Studies
  • Quality of Life
  • Severity of Illness Index
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome

Substances

  • Analgesics
  • Drug Combinations
  • Oral Sprays
  • Cannabidiol
  • Dronabinol
  • nabiximols