Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity

F. Patti, S Messina, C. Solaro, M P Amato, R Bergamaschi, M. S. Bonavita, R. Bruno Bossio, Vincenzo Brescia Morra, G F Costantino, P. Cavalla, D Centonze, G Comi, S. Cottone, M. Danni, A Francia, Alberto Gajofatto, C. Gasperini, A. Ghezzi, A. Iudice, G. LusGiorgia Teresa Maniscalco, M. G. Marrosu, M. Matta, Massimiliano Mirabella, E Montanari, C. Pozzilli, M Rovaris, E Sessa, Daniele Spitaleri, Maria Trojano, P. Valentino, M. Zappia, SA.FE. study group

Research output: Contribution to journalArticlepeer-review


BACKGROUND: The approval of 9-δ-tetrahydocannabinol and cannabidiol (THC:CBD) oromucosal spray (Sativex) for the management of treatment-resistant multiple sclerosis (MS) spasticity opened a new opportunity for many patients. The aim of our study was to describe Sativex effectiveness and adverse events profile in a large population of Italian patients with MS in the daily practice setting.

METHODS: We collected data of all patients starting Sativex between January 2014 and February 2015 from the mandatory Italian medicines agency (AIFA) e-registry. Spasticity assessment by the 0-10 numerical rating scale (NRS) scale is available at baseline, after 1 month of treatment (trial period), and at 3 and 6 months.

RESULTS: A total of 1615 patients were recruited from 30 MS centres across Italy. After one treatment month (trial period), we found 70.5% of patients reaching a ≥20% improvement (initial response, IR) and 28.2% who had already reached a ≥30% improvement (clinically relevant response, CRR), with a mean NRS score reduction of 22.6% (from 7.5 to 5.8). After a multivariate analysis, we found an increased probability to reach IR at the first month among patients with primary and secondary progressive MS, (n=1169, OR 1.4 95% CI 1.04 to 1.9, p=0.025) and among patients with >8 NRS score at baseline (OR 1.8 95% CI 1.3-2.4 p<0.001). During the 6 months observation period, 631(39.5%) patients discontinued treatment. The main reasons for discontinuation were lack of effectiveness (n=375, 26.2%) and/or adverse events (n=268, 18.7%).

CONCLUSIONS: Sativex can be a useful and safe option for patients with MS with moderate to severe spasticity resistant to common antispastic drugs.

Original languageEnglish
Pages (from-to)944-51
Number of pages8
JournalJournal of Neurology, Neurosurgery and Psychiatry
Issue number9
Publication statusPublished - Sep 2016


  • Journal Article


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