Real-world data confirmed THC/CBD spray effectiveness for MS spasticity without driving impairment | Research

The takeaway

Post-marketing studies across the UK, Germany, and Spain confirmed that THC/CBD spray was effective and safe for MS spasticity in daily practice, with no evidence of abuse, misuse, or driving impairment.

Read this if you want to know how THC/CBD spray performs in real-world clinical practice for MS spasticity.

41% clinically relevant response in real practice, matching clinical trial results

What the researchers found

This review compiled observational data from post-marketing registries and real-world studies of THC/CBD oromucosal spray (Sativex) for MS spasticity. The proportion of patients achieving clinically relevant improvement (30% or more reduction in spasticity) at 3 months was 41%, comparable to the 36% seen in the pivotal clinical trial.

Notably, average daily doses in real practice were approximately 25% lower than those used in clinical trials, suggesting patients found effective doses below what was tested. There was no evidence of abuse, misuse, or other adverse events of special interest with this cannabis-based medicine. A specific study on driving ability found no impairment.

Why it matters

Clinical trials show what a drug can do under ideal conditions; real-world studies show what happens in daily practice. This data confirmed that the clinical trial results translated to real patients, with effectiveness maintained and no emerging safety concerns.

The numbers in context

41% clinically relevant response at 3 months (vs. 36% in pivotal trial). Average daily doses approximately 25% lower than in clinical trials. No evidence of abuse, misuse, or driving impairment.

How the study worked

Review of post-marketing safety registries from the UK and Germany, a safety study from Spain, and two German observational studies including one on driving ability.

What this study cannot tell us

Observational studies are inherently less rigorous than RCTs. Selection bias may affect which patients continue treatment. Post-marketing registries may underreport adverse events. The driving study details were not fully described.

How to read the evidence

Post-marketing observational data from multiple countries, providing real-world validation of clinical trial findings.

When this study was published

Published in 2014.

The bigger picture

Post-marketing surveillance is particularly important for cannabis-based medicines because concerns about abuse potential and impairment are central to the regulatory debate. Finding no abuse signal and no driving impairment in real-world use addresses two of the most frequently raised concerns.

Questions still open

Does long-term use beyond 3 months maintain the same response rate? Why do patients use lower doses than clinical trials? Would other cannabis-based medicines show similar post-marketing safety profiles?

Common questions

Does THC/CBD spray work as well in practice as in clinical trials?

Yes. Post-marketing data showed a 41% clinically relevant response rate at 3 months, comparable to the 36% in the pivotal trial, and patients achieved this with approximately 25% lower doses.

Can you drive while using THC/CBD spray for MS?

A specific observational study included in this review found no impairment of driving ability with THC/CBD spray use. There was also no evidence of abuse or misuse in the post-marketing data.

Read the original research

Advances in the management of MS spasticity: recent observational studies.

European neurology, 72 Suppl 1, 12-4

View on PubMed ↗Publisher’s paper ↗

Citation

Fernández, Oscar. (2014). Advances in the management of MS spasticity: recent observational studies.. European neurology, 72 Suppl 1, 12-4. https://doi.org/10.1159/000367618