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THC:CBD in Daily Practice: Available Data from UK, Germany and Spain
1Institute of Clinical Neuroscience, Neurology Department, Hospital Regional Universitario Carlos Haya, FIMABIS, Malaga, Spain.
European Neurology
|February 23, 2016
Summary
Sativex (THC:CBD) oromucosal spray shows a positive risk-benefit profile for managing multiple sclerosis (MS) spasticity in real-world use. Long-term studies confirm its safety and efficacy, with no new concerns identified.
Area of Science:
- Neurology
- Pharmacology
- Cannabinoid Medicine
Background:
- Sativex (THC:CBD) oromucosal spray has been available since 2010 for treatment-resistant multiple sclerosis (MS) spasticity.
- Real-world data collection on its use has been ongoing through various projects.
Purpose of the Study:
- To evaluate the long-term safety and efficacy of Sativex (THC:CBD) oromucosal spray in managing MS spasticity.
- To assess the risk-benefit profile and continuation rates in routine clinical practice.
Main Methods:
- Retrospective registry study in the UK, Germany, and Switzerland involving over 900 patients.
- Prospective safety study in Spain with 207 patients from 13 specialized MS centers.
Main Results:
- Retrospective registry analysis indicated a positive risk-benefit profile with 68% long-term continuation (1-year mean follow-up).
- Prospective Spanish study showed similar 1-year continuation rates (64.7%) and a comparable safety profile.
- No new safety concerns were identified; adverse events of special interest were limited, with no evidence of addiction, abuse, or misuse.
Conclusions:
- Observational studies demonstrate homogeneity in findings, supporting the use of THC:CBD oromucosal spray for MS spasticity management in daily practice.
- The data suggest Sativex is a safe and effective option for long-term management of spasticity in multiple sclerosis patients.
