Abstract
Abstract Background: Subsequent to introduction in June 2010 in the United Kingdom and Spain of tetrahydrocannabinol (THC) : cannabidiol (CBD) oromucosal spray (Sativex®) for management of multiple sclerosis (MS) spasticity, and as part of a wider initiative to address British health authority requirements for post-marketing surveillance to identify possible short- and long-term risks associated with its use as a condition of marketing authorization, studies were undertaken to evaluate the safety of THC: CBDspray under clinical practice conditions. Methods: This prospective, observational, multicentre study reports on 205 patients with treatment-resistant MS spasticity who were prescribed THC: CBD spray as add-on therapy to existing antispasticity medications at 13 specialist MS centres across Spain. Safety evaluations were performed after 6 and 12 months’ exposure to THC: CBD spray. Results: Add-on THC: CBD spray was well tolerated during up to 12 months’ exposure. No new safety signals emerged and THC: CBD spray was not associated with any clinically-relevant occurrence of adverse events of special interest with cannabinoid-based medications such as falls requiring medical attention, psychiatric or psychotic symptoms, memory impairment, changes in driving ability, addiction or abuse. After 6 months’ and 12 months’ exposure, treating physicians considered that 139 patients (68% of original cohort) and 124 patients (60.5% of original cohort), respectively, were deriving sufficient anti-spasticity benefit from THC: CBD spray to warrant continued treatment. The mean dosage of THC: CBD spray (6.6 sprays/day) and carer requirements (~14.5 hours/day) remained stable throughout the study. Conclusions: THC: CBDspray as add-on therapy showed good tolerability and sustained anti-spasticity benefit in a relevant proportion (60.5%) of Spanish patients with MS-related spasticity treated for up to 12 months in everyday clinical practice.
Highlights
Spasticity is a common and highly distressing symptom of multiple sclerosis (MS) that typically adds to the burden of disease [1,2]
The objective of the study was to identify, characterise and quantify potential risks associated with use of THC:CBD spray by systematically collecting information about all suspected adverse drug reactions that occurred in patients in the first 12 months from the start of treatment under usual clinical practice conditions in Spain
Between July 2011 and December 2012, 207 patients with moderate to severe treatment-resistant MS spasticity were recruited into the study at specialist MS centres across Spain
Summary
Spasticity is a common and highly distressing symptom of multiple sclerosis (MS) that typically adds to the burden of disease [1,2]. Spasms and pain can limit mobility and interfere with activities of daily living. Associated symptoms such as disturbed sleep, depression and loss of personal independence combine to have a profoundly negative impact on patient’s quality of life. Subsequent to introduction in June 2010 in the United Kingdom and Spain of tetrahydrocannabinol (THC) : cannabidiol (CBD) oromucosal spray (Sativex®) for management of multiple sclerosis (MS) spasticity, and as part of a wider initiative to address British health authority requirements for post-marketing surveillance to identify possible short- and long-term risks associated with its use as a condition of marketing authorization, studies were undertaken to evaluate the safety of THC:CBD spray under clinical practice conditions
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