THCCBD in Daily Practice Available Data from UK, Germany and Spain.
From the time Sativex (THCCBD) oromucosal spray first became available in European Union countries in 2010 for the management of treatment-resistant multiple sclerosis (MS) spasticity, data from daily practice have been collected through various projects. A retrospective registry study and a prospective safety study of THCCBD oromucosal spray are reported. The most recent analysis of a retrospective registry established in the United Kingdom (UK), Germany and Switzerland, which collected safety data on more than 900 patients, has indicated a positive risk-benefit profile for THCCBD oromucosal spray during long-term use. Long-term continuation rates were 68% (mean follow-up time 1 year) and the mean dose was 5.4 spraysday. No new safety concerns were identified, and adverse events of special interest for a cannabis-based medicine were limited. The UK registry has since been closed but remains open in Germany and Switzerland. A prospective safety study undertaken in Spain involved 207 patients from 13 specialized MS centres who had been prescribed THCCBD oromucosal spray. The findings aligned closely with the UKGermanSwiss registry data in terms of 1-year continuation rates (64.7%), mean daily dose (6.6 spraysday) and safety profile, including no evidence of addiction, abuse or misuse. The homogeneity between these observational studies supports the interest in THCCBD oromucosal spray for management of MS spasticity in daily practice.