Review of Sativex for multiple sclerosis spasticity | Research

The takeaway

Clinical trials showed Sativex spray reduced MS spasticity severity and improved daily functioning, with side effects mostly mild to moderate and manageable through gradual dose increases.

Read this if you have MS spasticity and want to understand the clinical evidence for cannabis-based treatment.

Gradual dose uptitration markedly reduced side effects

What the researchers found

This review compiled clinical trial evidence for Sativex oromucosal spray in MS-related spasticity. Randomized controlled trials reported reductions in spasticity severity when Sativex was added to existing treatments, along with improved ability to perform daily activities.

Both patients and caregivers perceived functional improvement. Common adverse events included dizziness, diarrhea, fatigue, nausea, headache, and somnolence, but these were generally mild to moderate and could be substantially reduced by gradually increasing the dose rather than starting at full dose.

The review positioned Sativex as a useful add-on therapy when existing spasticity medications provided insufficient relief.

Why it matters

MS spasticity significantly impacts quality of life, and existing drug treatments often provide limited benefit with poor tolerability. Sativex offered an additional option, particularly for patients who had not responded adequately to conventional anti-spasticity medications.

The numbers in context

Common adverse events: dizziness, diarrhea, fatigue, nausea, headache, somnolence. Side effects were mild-to-moderate intensity. Gradual uptitration markedly reduced adverse event incidence.

How the study worked

Review of published randomized controlled trials and clinical experience data for Sativex in MS spasticity. Included the GW Pharmaceuticals integrated safety analysis.

What this study cannot tell us

Review focused on initial clinical trial data. Long-term safety and efficacy data was still accumulating. The subjective nature of spasticity measurement makes blinding challenging. Industry data was included.

How to read the evidence

Review of randomized controlled trials. Good quality evidence base, though the review itself was narrative rather than systematic.

When this study was published

Published in 2011. Sativex has since been approved for MS spasticity in multiple countries with additional long-term safety data.

The bigger picture

Sativex became one of the first cannabis-derived prescription medicines approved in multiple countries for MS spasticity. Its clinical profile helped shift the conversation about medical cannabis from anecdotal use to evidence-based prescribing.

Questions still open

Does Sativex maintain efficacy over years of use? Which MS patients benefit most? Can responders be identified early to avoid unnecessary treatment?

Common questions

Does Sativex cure MS spasticity?

No. Sativex was studied as an add-on to existing treatments and reduced symptom severity rather than curing the underlying condition. It was most beneficial for patients whose spasticity was not adequately controlled by conventional medications.

How are side effects managed?

The key strategy is gradual dose increase (uptitration) rather than starting at full dose. This approach markedly reduced the incidence of dizziness, fatigue, and nausea that occurred when starting at higher doses.

Read the original research

THC and CBD oromucosal spray (Sativex®) in the management of spasticity associated with multiple sclerosis.

Expert review of neurotherapeutics, 11(5), 627-37

View on PubMed ↗Publisher’s paper ↗

Citation

Sastre-Garriga, Jaume; Vila, Carlos; Clissold, Stephen; Montalban, Xavier. (2011). THC and CBD oromucosal spray (Sativex®) in the management of spasticity associated with multiple sclerosis.. Expert review of neurotherapeutics, 11(5), 627-37. https://doi.org/10.1586/ern.11.47