: Presented at ECTRIMS
LONDON -- September 17, 2016 -- New data support the use of a cannabinoid-based oromucosal spray as an add-on option to treat multiple sclerosis (MS)-related resistant spasticity.
The results, which are drawn from a large sample of patients treated with the spray in everyday clinical practice in Europe, were presented here at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Patrick Vermersch, MD, Universitaire de Lille, Lille, France, and colleagues collected data from 433 patients starting treatment with the spray at specialist centres in Italy, Norway, and Denmark.
The spray contains the active substances delta-9-tetrahydrocannabinol and cannabidiol (THC:CBD) at a ratio of 1:1.
The study aimed to augment the positive clinical findings from randomised clinical trials (RCTs) evaluating the spray.
All patients had moderate-to-severe MS spasticity and had not responded adequately to other anti-spasticity medications.
Effectiveness was measured by rates of treatment continuation and changes from baseline in scores on the spasticity numerical (0-10) rating scale (NRS) and the modified Ashworth scale (0-4).
After a 1-month trial period, patients who had achieved ≥20% improvement in their spasticity NRS score could continue.
Overall, 349 participants continued treatment with the spray beyond the first month visit, and 281 patients continued treatment beyond the third month visit.
Spasticity scores on all scales improved significantly improved in study completers at 3 months: 0-10 NRS (mean 6.9 to 5.4) and Ashworth scale (mean 2.6 to 2.3).
The usual 3-level categorical scale for the severity of spasticity (mild/moderate/severe) showed a marked reduction in severe cases from 37.2% to 12.9%.
The percentage of patients with no restrictions in their daily activities resulting from their spasticity was significantly reduced from 30.2% to 22.8%.
Roughly 20% of patients improved ≥30% on their NRS score.
Dr. Vermersch said that the results compare favourably with results from prior RCTs and observational studies.
Funding for this study was provided by Almirall S.A.
[Presentation title: Tetrahydrocannabinol + Cannabidiol Oromucosal Spray for Multiple Sclerosis-Resistant Spasticity on Daily Practice, New Data. Abstract P757]