Long-term effectiveness and safety of nabiximols (tetrahydrocannabinol/cannabidiol oromucosal spray) in clinical practice.

Background: Nabiximols (Sativex(R)), 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.