Sativex Works for MS Spasticity Even in Patients Who Have Failed Other Treatments | Research

The takeaway

Post hoc analysis of a clinical trial showed that the THC:CBD spray Sativex improved MS spasticity and sleep quality regardless of how many previous antispasticity medications had failed.

Read this if you have MS spasticity that has not responded well to standard medications like baclofen or tizanidine.

Effective even after failure of both baclofen and tizanidine

What the researchers found

A key question for any treatment is whether it works in difficult-to-treat patients. This post hoc analysis examined whether the THC:CBD spray Sativex helped MS spasticity patients who had already failed standard treatments.

Among 241 patients, researchers identified two groups: those who had failed at least one course of baclofen or tizanidine (162 patients), and those who had failed both (57 patients). In both groups, Sativex significantly outperformed placebo.

The treatment achieved both minimal clinically important improvement (18%+ spasticity reduction) and clinically important improvement (30%+ reduction) more often than placebo, regardless of pretreatment history. Sleep quality and walking ability also improved. Tolerability was unaffected by the number of prior treatment failures.

Why it matters

Treatment-resistant patients are the population most in need of alternative therapies. This analysis demonstrates that Sativex's effectiveness is not limited to "easy" cases and that patients who have exhausted conventional options can still benefit.

The numbers in context

241 intent-to-treat patients. Group 1 (1+ failed therapy): 162 patients. Group 2 (2+ failed therapies): 57 patients. Significant improvement on MCID (18%+ improvement) and CID (30%+ improvement) versus placebo in all groups. Sleep quality and walking speed also improved.

How the study worked

Post hoc analysis of an enriched-design randomized controlled trial of THC:CBD spray versus placebo. Patients were stratified by history of failed baclofen and/or tizanidine therapy. Outcomes included spasticity NRS score, sleep quality, and timed 10-meter walk.

What this study cannot tell us

Post hoc analysis is exploratory and hypothesis-generating rather than confirmatory. The subgroups were defined after the trial completed, which increases the risk of finding spurious results. Sample sizes, particularly for the dual-failure group, were small.

How to read the evidence

Post hoc analysis of an enriched-design RCT. Good underlying trial quality, but subgroup analysis is exploratory.

When this study was published

Published in 2016. Sativex has continued to accumulate evidence for MS spasticity since.

The bigger picture

This finding strengthens the clinical case for Sativex as a treatment for MS spasticity by showing it helps precisely the patients who need it most: those who have already tried and failed other treatments.

Questions still open

Would Sativex perform even better as a first-line rather than last-resort treatment? Is there a ceiling to how many failed therapies predict non-response?

Common questions

Does Sativex work if other MS spasticity drugs have failed?

Yes. This analysis showed Sativex was effective even in patients who had failed both baclofen and tizanidine, the two standard MS spasticity medications.

Does previous treatment failure affect Sativex tolerability?

No. Side effects and tolerability were not influenced by how many previous treatments had failed.

Read the original research

Influence of Previous Failed Antispasticity Therapy on the Efficacy and Tolerability of THC:CBD Oromucosal Spray for Multiple Sclerosis Spasticity.

European neurology, 75(5-6), 236-43

View on PubMed ↗Publisher’s paper ↗

Citation

Haupts, Michael; Vila, Carlos; Jonas, Anna; Witte, Kerstin; Álvarez-Ossorio, Lourdes. (2016). Influence of Previous Failed Antispasticity Therapy on the Efficacy and Tolerability of THC:CBD Oromucosal Spray for Multiple Sclerosis Spasticity.. European neurology, 75(5-6), 236-43. https://doi.org/10.1159/000445943