Background The δ-9-tetrahydrocannabinol-cannabidiol (THC-CBD) oromucosal spray (Sativex) is a standardised cannabinoid based medicine for add on treatment of resistant multiple sclerosis (MS) induced spasticity.
Purpose To evaluate the use of oromucosal spray Sativex in terms of efficacy for symptoms and functional impairment associated with resistant MS induced spasticity and safety according to type of MS.
Material and methods A retrospective cohort study was conducted in a university hospital in South Spain in patients who commenced Sativex between March 2015 and November 2015. Data were retrieved from the electronic medical records (Diraya) and the dispensing programme for outpatient (Farmatools). Patients were classified by type of MS: relapsing remitting (RR), primary progressive (PP) and secondary progressive (SP). Evaluation was performed on day 0 and day 60 of treatment with Sativex. The Modified Ashworth Scale was used for grading spasticity where ‘improvement’ was defined as >20% deviation from baseline.
Results 14 patients were included. 4 (28.6%) were men with a median (IQR) age of 47.5 years (37–69). Types of MS were: 10 (71.4%) RR, 1 (7.1%) PP and 3 (21.4%) SP. The overall response, defined as ‘improvement’ to Sativex, was 9 (64.3%) and by type of MS: 6/10 (60%) RR, 1/1 (100%) PP and 2/3 (66.7%) SP. Only 1 patient (7.1%) discontinued treatment due to drug related adverse events. 2 additional patient were treated with Sativex but excluded from this analysis due to a diagnose different from MS.
Conclusion In our cohort, oromucosal spray Sativex was a well tolerated drug and an effective alternative for the management of resistant MS induced spasticity. As for MS type subgroup analysis, a greater sample size is needed for more robust conclusions.
No conflict of interest
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.