Real-World Data on Sativex (THC:CBD Spray) for MS Spasticity Across Three Countries | Research

The takeaway

Registry data from over 900 patients in the UK, Germany, Switzerland, and Spain showed that the THC:CBD oromucosal spray Sativex had a positive risk-benefit profile with no evidence of addiction, abuse, or misuse during long-term use.

Read this if you or someone you know uses or is considering Sativex for multiple sclerosis spasticity.

68% of patients still using Sativex at one year, with no addiction signals

What the researchers found

Since Sativex became available in European countries in 2010 for treatment-resistant multiple sclerosis spasticity, real-world data has been collected through registry and observational studies across multiple countries.

The most recent analysis of registry data from over 900 patients in the UK, Germany, and Switzerland showed long-term continuation rates of 68% at one year, with an average dose of 5.4 sprays per day. No new safety concerns emerged, and adverse events of special interest for a cannabis-based medicine were limited.

A separate prospective study in Spain involving 207 patients from 13 specialized MS centers produced closely matching results: 64.7% continuation rate at one year, average dose of 6.6 sprays per day, and a similar safety profile with no evidence of addiction, abuse, or misuse.

Why it matters

Clinical trials show a drug works under controlled conditions. Real-world evidence shows whether it works in everyday medical practice, where patients have more complex health situations and less supervision. The consistency of these results across four countries strengthens the case that Sativex is both effective and well-tolerated for MS spasticity.

The numbers in context

Registry data (UK/Germany/Switzerland): 68% one-year continuation rate, mean dose 5.4 sprays/day, 900+ patients. Spain study: 64.7% one-year continuation rate, mean dose 6.6 sprays/day, 207 patients from 13 centers. No evidence of addiction, abuse, or misuse in either dataset.

How the study worked

Two data sources were examined: a retrospective registry study collecting safety data from patients in the UK, Germany, and Switzerland (900+ patients), and a prospective safety study from 13 specialized MS centers in Spain (207 patients). Both tracked continuation rates, dosing, and adverse events.

What this study cannot tell us

Observational studies lack the control of randomized trials and cannot account for all confounding factors. Patients who continued treatment may differ systematically from those who stopped. The studies focused on MS spasticity and cannot be generalized to other conditions.

How to read the evidence

Large real-world dataset across multiple countries, but observational design without randomization or placebo controls.

When this study was published

Published in 2016 with data from 2010 onward. Sativex has since accumulated additional years of real-world evidence.

The bigger picture

The convergence of safety and effectiveness data across different countries, healthcare systems, and study designs provides robust real-world validation of THC:CBD as a therapeutic option. The absence of addiction or abuse signals is particularly notable given ongoing concerns about cannabis-based medicines.

Questions still open

Would these continuation rates and safety profiles hold over periods longer than one year? How do these real-world outcomes compare to other MS spasticity treatments?

Common questions

Is Sativex addictive?

In registry data from over 1,100 patients across four European countries, there was no evidence of addiction, abuse, or misuse during long-term treatment.

How many patients stay on Sativex long-term?

Approximately 65-68% of patients were still using Sativex at the one-year mark, suggesting most patients find meaningful benefit.

Read the original research

THC:CBD in Daily Practice: Available Data from UK, Germany and Spain.

European neurology, 75 Suppl 1, 1-3

View on PubMed ↗Publisher’s paper ↗

Citation

Fernández, Óscar. (2016). THC:CBD in Daily Practice: Available Data from UK, Germany and Spain.. European neurology, 75 Suppl 1, 1-3. https://doi.org/10.1159/000444234